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1. Clinical validation of an AI-based pathology tool for scoring of metabolic dysfunction-associated steatohepatitis

Author

Pulaski, Hanna, Harrison, Stephen A., Mehta, Shraddha S., Sanyal, Arun J., Vitali, Marlena C., Manigat, Laryssa C., Hou, Hypatia, Madasu Christudoss, Susan P., Hoffman, Sara M., Stanford-Moore, Adam, Egger, Robert, Glickman, Jonathan, Resnick, Murray, Patel, Neel, Taylor, Cristin E., Myers, Robert P., Chung, Chuhan, Patterson, Scott D., Sejling, Anne-Sophie, Minnich, Anne, Baxi, Vipul, Subramaniam, G. Mani, Anstee, Quentin M., Loomba, Rohit, Ratziu, Vlad, Montalto, Michael C., Anderson, Nick P., Beck, Andrew H., and Wack, Katy E.

Published
2024
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2. Design of the phase 3 MAESTRO clinical program to evaluate resmetirom for the treatment of nonalcoholic steatohepatitis

Author

Harrison, Stephen A, Ratziu, Vlad, Anstee, Quentin M, Noureddin, Mazen, Sanyal, Arun J, Schattenberg, Jörn M, Bedossa, Pierre, Bashir, Mustafa R, Schneider, David, Taub, Rebecca, Bansal, Meena, Kowdley, Kris V, Younossi, Zobair M, and Loomba, Rohit

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Clinical Trials and Supportive Activities, Liver Disease, Hepatitis, Digestive Diseases, Chronic Liver Disease and Cirrhosis, Detection, screening and diagnosis, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, 4.2 Evaluation of markers and technologies, Oral and gastrointestinal, Good Health and Well Being, Adult, Humans, Non-alcoholic Fatty Liver Disease, Liver, Liver Cirrhosis, Biomarkers, Pharmacology and Pharmaceutical Sciences, Gastroenterology & Hepatology, Clinical sciences, Pharmacology and pharmaceutical sciences
Abstract

BackgroundNon-alcoholic steatohepatitis (NASH) is a progressive form of non-alcoholic fatty liver disease (NAFLD) associated with steatosis, hepatocellular injury, inflammation and fibrosis. In a Phase 2 trial in adults with NASH (NCT02912260), resmetirom, an orally administered, liver-targeted thyroid hormone receptor-β selective agonist, significantly reduced hepatic fat (via imaging) and resolved NASH without worsening fibrosis (via liver biopsy) in a significant number of patients compared with placebo.AimsTo present the design of the Phase 3 MAESTRO clinical programme evaluating resmetirom for treatment of NASH (MAESTRO-NAFLD-1 [NCT04197479], MAESTRO-NAFLD-OLE [NCT04951219], MAESTRO-NASH [NCT03900429], MAESTRO-NASH-OUTCOMES [NCT05500222]).MethodsMAESTRO-NASH is a pivotal serial biopsy trial in up to 2000 adults with biopsy-confirmed at-risk NASH. Patients are randomised to a once-daily oral placebo, 80 mg resmetirom, or 100 mg resmetirom. Liver biopsies are conducted at screening, week 52 and month 54. MAESTRO-NAFLD-1 is a 52-week safety trial in ~1400 adults with NAFLD/presumed NASH (based on non-invasive testing); ~700 patients from MAESTRO-NAFLD-1 are enrolled in MAESTRO-NAFLD-OLE, a 52-week active treatment extension to further evaluate safety. MAESTRO-NASH-OUTCOMES is enrolling 700 adults with well-compensated NASH cirrhosis to evaluate the potential for resmetirom to slow progression to hepatic decompensation events. Non-invasive tests (biomarkers, imaging) are assessed longitudinally throughout, in addition to validated patient-reported outcomes.ConclusionThe MAESTRO clinical programme was designed in conjunction with regulatory authorities to support approval of resmetirom for treatment of NASH. The surrogate endpoints, based on week 52 liver biopsy, serum biomarkers and imaging, are confirmed by long-term clinical liver-related outcomes in MAESTRO-NASH (month 54) and MAESTRO-NASH-OUTCOMES (time to event).

Published
2024

3. Impact of age on NIS2+™ and other non-invasive blood tests for the evaluation of liver disease and detection of at-risk MASH

Author

Anstee, Quentin M, Magnanensi, Jeremy, Hajji, Yacine, Caron, Alexandra, Majd, Zouher, Rosenquist, Christian, Hum, Dean W, Staels, Bart, Connelly, Margery A, Loomba, Rohit, Harrison, Stephen A, Ratziu, Vlad, and Sanyal, Arun J

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Chronic Liver Disease and Cirrhosis, Clinical Research, Liver Disease, Digestive Diseases, Oral and gastrointestinal, Clinical sciences
Published
2024

4. Utility of pathologist panels for achieving consensus in NASH histologic scoring in clinical trials: Data from a phase 3 study.

Author

Sanyal, Arun, Anstee, Quentin, Ratziu, Vlad, Kowdley, Kris, Rinella, Mary, Harrison, Stephen, Resnick, Murray, Capozza, Thomas, Sawhney, Sangeeta, Shelat, Nirav, Younossi, Zobair, and Loomba, Rohit

Subjects
Humans, Consensus, Pathologists, Non-alcoholic Fatty Liver Disease, Reproducibility of Results, Inflammation, Fibrosis
Abstract

BACKGROUND: Liver histopathologic assessment is the accepted surrogate endpoint in NASH trials; however, the scoring of NASH Clinical Research Network (CRN) histologic parameters is limited by intraobserver and interobserver variability. We designed a consensus panel approach to minimize variability when using this scoring system. We assessed agreement between readers, estimated linear weighted kappas between 2 panels, compared them with published pairwise kappa estimates, and addressed how agreement or disagreement might impact the precision and validity of the surrogate efficacy endpoint in NASH trials. METHODS: Two panels, each comprising 3 liver fellowship-trained pathologists who underwent NASH histology training, independently evaluated scanned whole slide images, scoring fibrosis, inflammation, hepatocyte ballooning, and steatosis from baseline and month 18 biopsies for 100 patients from the precirrhotic NASH study REGENERATE. The consensus score for each parameter was defined as agreement by ≥2 pathologists. If consensus was not reached, all 3 pathologists read the slide jointly to achieve a consensus score. RESULTS: Between the 2 panels, the consensus was 97%-99% for steatosis, 91%-93% for fibrosis, 88%-92% for hepatocyte ballooning, and 84%-91% for inflammation. Linear weighted kappa scores between panels were similar to published NASH CRN values. CONCLUSIONS: A panel of 3 trained pathologists independently scoring 4 NASH CRN histology parameters produced high consensus rates. Interpanel kappa values were comparable to NASH CRN metrics, supporting the accuracy and reproducibility of this method. The high concordance for fibrosis scoring was reassuring, as fibrosis is predictive of liver-specific outcomes and all-cause mortality.

Published
2024

5. A multisociety Delphi consensus statement on new fatty liver disease nomenclature

Author

Rinella, Mary E, Lazarus, Jeffrey V, Ratziu, Vlad, Francque, Sven M, Sanyal, Arun J, Kanwal, Fasiha, Romero, Diana, Abdelmalek, Manal F, Anstee, Quentin M, Arab, Juan Pablo, Arrese, Marco, Bataller, Ramon, Beuers, Ulrich, Boursier, Jerome, Bugianesi, Elisabetta, Byrne, Christopher D, Narro, Graciela E Castro, Chowdhury, Abhijit, Cortez-Pinto, Helena, Cryer, Donna R, Cusi, Kenneth, El-Kassas, Mohamed, Klein, Samuel, Eskridge, Wayne, Fan, Jiangao, Gawrieh, Samer, Guy, Cynthia D, Harrison, Stephen A, Kim, Seung Up, Koot, Bart G, Korenjak, Marko, Kowdley, Kris V, Lacaille, Florence, Loomba, Rohit, Mitchell-Thain, Robert, Morgan, Timothy R, Powell, Elisabeth E, Roden, Michael, Romero-Gómez, Manuel, Silva, Marcelo, Singh, Shivaram Prasad, Sookoian, Silvia C, Spearman, C Wendy, Tiniakos, Dina, Valenti, Luca, Vos, Miriam B, Wong, Vincent Wai-Sun, Xanthakos, Stavra, Yilmaz, Yusuf, Younossi, Zobair, Hobbs, Ansley, Villota-Rivas, Marcela, Newsome, Philip N, and group, NAFLD Nomenclature consensus

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Liver Disease, Digestive Diseases, Clinical Research, Hepatitis, Chronic Liver Disease and Cirrhosis, Substance Misuse, Oral and gastrointestinal, Good Health and Well Being, Female, Male, Humans, Non-alcoholic Fatty Liver Disease, Delphi Technique, Ethanol, Consensus, Hepatomegaly, NAFLD Nomenclature consensus group, ALD, Delphi, MASH, MASLD, Met-ALD, NAFLD, alcohol, metabolic, nomenclature, stigma, Public Health and Health Services, Gastroenterology & Hepatology, Clinical sciences
Abstract

The principal limitations of the terms NAFLD and NASH are the reliance on exclusionary confounder terms and the use of potentially stigmatising language. This study set out to determine if content experts and patient advocates were in favour of a change in nomenclature and/or definition. A modified Delphi process was led by three large pan-national liver associations. The consensus was defined a priori as a supermajority (67%) vote. An independent committee of experts external to the nomenclature process made the final recommendation on the acronym and its diagnostic criteria. A total of 236 panellists from 56 countries participated in 4 online surveys and 2 hybrid meetings. Response rates across the 4 survey rounds were 87%, 83%, 83%, and 78%, respectively. Seventy-four percent of respondents felt that the current nomenclature was sufficiently flawed to consider a name change. The terms "nonalcoholic" and "fatty" were felt to be stigmatising by 61% and 66% of respondents, respectively. Steatotic liver disease was chosen as an overarching term to encompass the various aetiologies of steatosis. The term steatohepatitis was felt to be an important pathophysiological concept that should be retained. The name chosen to replace NAFLD was metabolic dysfunction-associated steatotic liver disease (MASLD). There was consensus to change the definition to include the presence of at least 1 of 5 cardiometabolic risk factors. Those with no metabolic parameters and no known cause were deemed to have cryptogenic steatotic liver disease. A new category, outside pure metabolic dysfunction-associated steatotic liver disease, termed metabolic and alcohol related/associated liver disease (MetALD), was selected to describe those with metabolic dysfunction-associated steatotic liver disease, who consume greater amounts of alcohol per week (140-350 g/wk and 210-420 g/wk for females and males, respectively). The new nomenclature and diagnostic criteria are widely supported and non-stigmatising, and can improve awareness and patient identification.

Published
2023

6. A multisociety Delphi consensus statement on new fatty liver disease nomenclature.

Author

Rinella, Mary, Lazarus, Jeffrey, Ratziu, Vlad, Francque, Sven, Sanyal, Arun, Kanwal, Fasiha, Romero, Diana, Abdelmalek, Manal, Anstee, Quentin, Arab, Juan, Arrese, Marco, Bataller, Ramon, Beuers, Ulrich, Boursier, Jerome, Bugianesi, Elisabetta, Byrne, Christopher, Castro Narro, Graciela, Chowdhury, Abhijit, Cortez-Pinto, Helena, Cryer, Donna, Cusi, Kenneth, El-Kassas, Mohamed, Klein, Samuel, Eskridge, Wayne, Fan, Jiangao, Gawrieh, Samer, Guy, Cynthia, Harrison, Stephen, Kim, Seung, Koot, Bart, Korenjak, Marko, Kowdley, Kris, Lacaille, Florence, Powell, Elisabeth, Roden, Michael, Romero-Gómez, Manuel, Silva, Marcelo, Singh, Shivaram, Sookoian, Silvia, Spearman, C, Tiniakos, Dina, Valenti, Luca, Vos, Miriam, Wong, Vincent, Xanthakos, Stavra, Yilmaz, Yusuf, Younossi, Zobair, Hobbs, Ansley, Villota-Rivas, Marcela, Newsome, Philip, Mitchell-Thain, Robert, Morgan, Timothy, and Loomba, Rohit

Subjects
Male, Female, Humans, Non-alcoholic Fatty Liver Disease, Delphi Technique, Hepatomegaly, Surveys and Questionnaires
Abstract

The principal limitations of the terms NAFLD and NASH are the reliance on exclusionary confounder terms and the use of potentially stigmatising language. This study set out to determine if content experts and patient advocates were in favor of a change in nomenclature and/or definition. A modified Delphi process was led by three large pan-national liver associations. The consensus was defined a priori as a supermajority (67%) vote. An independent committee of experts external to the nomenclature process made the final recommendation on the acronym and its diagnostic criteria. A total of 236 panelists from 56 countries participated in 4 online surveys and 2 hybrid meetings. Response rates across the 4 survey rounds were 87%, 83%, 83%, and 78%, respectively. Seventy-four percent of respondents felt that the current nomenclature was sufficiently flawed to consider a name change. The terms nonalcoholic and fatty were felt to be stigmatising by 61% and 66% of respondents, respectively. Steatotic liver disease was chosen as an overarching term to encompass the various aetiologies of steatosis. The term steatohepatitis was felt to be an important pathophysiological concept that should be retained. The name chosen to replace NAFLD was metabolic dysfunction-associated steatotic liver disease. There was consensus to change the definition to include the presence of at least 1 of 5 cardiometabolic risk factors. Those with no metabolic parameters and no known cause were deemed to have cryptogenic steatotic liver disease. A new category, outside pure metabolic dysfunction-associated steatotic liver disease, termed metabolic and alcohol related/associated liver disease (MetALD), was selected to describe those with metabolic dysfunction-associated steatotic liver disease, who consume greater amounts of alcohol per week (140-350 g/wk and 210-420 g/wk for females and males, respectively). The new nomenclature and diagnostic criteria are widely supported and nonstigmatising, and can improve awareness and patient identification.

Published
2023

7. Tropifexor plus cenicriviroc combination versus monotherapy in nonalcoholic steatohepatitis: Results from the phase 2b TANDEM study.

Author

Anstee, Quentin, Lucas, Kathryn, Francque, Sven, Abdelmalek, Manal, Sanyal, Arun, Ratziu, Vlad, Gadano, Adrian, Rinella, Mary, Charlton, Michael, Mena, Edward, Schattenberg, Jörn, Noureddin, Mazen, Lazas, Donald, Goh, George, Sarin, Shiv, Yilmaz, Yusuf, Martic, Miljen, Stringer, Rowan, Kochuparampil, Jossy, Chen, Li, Rodriguez-Araujo, Gerardo, Chng, Elaine, Naoumov, Nikolai, Brass, Clifford, Pedrosa, Marcos, and Loomba, Rohit

Subjects
Humans, Non-alcoholic Fatty Liver Disease, Double-Blind Method, Treatment Outcome, Fibrosis, Body Weight
Abstract

BACKGROUND AND AIMS: With distinct mechanisms of action, the combination of tropifexor (TXR) and cenicriviroc (CVC) may provide an effective treatment for NASH. This randomized, multicenter, double-blind, phase 2b study assessed the safety and efficacy of TXR and CVC combination, compared with respective monotherapies. APPROACH AND RESULTS: Patients (N = 193) were randomized 1:1:1:1 to once-daily TXR 140 μg (TXR 140 ), CVC 150 mg (CVC), TXR 140 μg + CVC 150 mg (TXR 140 + CVC), or TXR 90 μg + CVC 150 mg (TXR 90 + CVC) for 48 weeks. The primary and secondary end points were safety and histological improvement, respectively. Rates of adverse events (AEs) were similar across treatment groups. Pruritus was the most frequently experienced AE, with highest incidence in the TXR 140 group (40.0%). In TXR and combination groups, alanine aminotransferase (ALT) decreased from baseline to 48 weeks (geometric mean change: -21%, TXR 140 ; -16%, TXR 140 + CVC; -13%, TXR 90 + CVC; and +17%, CVC). Reductions in body weight observed at week 24 (mean changes from baseline: TXR 140 , -2.5 kg; TXR 140 + CVC, -1.7 kg; TXR 90 + CVC, -1.0 kg; and CVC, -0.1 kg) were sustained to week 48. At least 1-point improvement in fibrosis stage/steatohepatitis resolution without worsening of fibrosis was observed in 32.3%/25.8%, 31.6%/15.8%, 29.7%/13.5%, and 32.5%/22.5% of patients in the TXR 140 , CVC, TXR 140 + CVC, and TXR 90 + CVC groups, respectively. CONCLUSIONS: The safety profile of TXR + CVC combination was similar to respective monotherapies, with no new signals. TXR monotherapy showed sustained ALT and body weight decreases. No substantial incremental efficacy was observed with TXR + CVC combination on ALT, body weight, or in histological end points compared with monotherapy.

Published
2023

9. Clinical Trial Landscape in NASH

Author

Harrison, Stephen A, Loomba, Rohit, Dubourg, Julie, Ratziu, Vlad, and Noureddin, Mazen

Subjects
Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Liver Disease, Clinical Research, Rare Diseases, Chronic Liver Disease and Cirrhosis, Liver Cancer, Cancer, Clinical Trials and Supportive Activities, Digestive Diseases, Obesity, Hepatitis, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Oral and gastrointestinal, Good Health and Well Being, Humans, Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2, Fibrosis, Liver Neoplasms, NASH, NAFLD, Cirrhosis, Liver, Clinical Sciences, Gastroenterology & Hepatology, Clinical sciences
Abstract

Nonalcoholic fatty liver disease consists of a spectrum starting from nonalcoholic fatty liver disease that may progress to nonalcoholic steatohepatitis (NASH), which can lead to fibrosis, cirrhosis, hepatocellular carcinoma, or even liver failure. The prevalence of NASH has increased in parallel with the rising rate of obesity and type 2 diabetes. Given the high prevalence and deadly complications of NASH, there have been significant efforts to develop effective treatments. Phase 2A studies have assessed various mechanisms of action across the spectrum of the disease, while phase 3 studies have focused mainly on NASH and fibrosis stage 2 and higher, as these patients have a higher risk of disease morbidity and mortality. The primary efficacy endpoints also vary, by using noninvasive tests in early-phase trials while relying on liver histological endpoints in phase 3 studies as required by regulatory agencies. Despite initial disappointment due to the failure of several drugs, recent phase 2 and 3 studies have shown promising results, with the first Food and Drug Administration-approved drug for NASH expected to be approved in 2023. In this review, we discuss the various drugs under development for NASH, their mechanisms of action, and the results of their clinical trials. We also highlight the potential challenges in developing pharmacological therapies for NASH.

Published
2023

10. SAT-417 Impact of age as a confounding factor on non-invasive blood-based tests for the evaluation of non-alcoholic fatty liver disease: comparing NIS2+TM to established tests

Author

Anstee, Quentin, Magnanensi, Jeremy, Hajji, Yacine, Caron, Alexandra, Majd, Zouher, Rosenquist, Christian, Hum, Dean, Staels, Bart, Connelly, Margery A, Loomba, Rohit, Harrison, Stephen, Ratziu, Vlad, and Sanyal, Arun

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Public Health and Health Services, Gastroenterology & Hepatology, Clinical sciences
Published
2023

11. OS-029 Analytical and clinical validation of AIM-NASH: a digital pathology tool for artificial intelligence-based measurement of non-alcoholic steatohepatitis histology

Author

Harrison, Stephen, Pulaski, Hanna, Vitali, Marlena, Manigat, Laryssa, Kaufman, Stephanie, Hou, Hypatia, Madasu, Susan, Hoffman, Sara, Stanford-Moore, Adam, Egger, Robert, Iyer, Janani, Glickman, Jonathan, Resnick, Murray, Patel, Neel, Taylor, Cristin, Mehta, Shraddha, Myers, Robert, Chung, Chuhan, Patterson, Scott, Sejling, Anne-Sophie, Minnich, Anne, Baxi, Vipul, Subramanian, Mani, Sanyal, Arun, Anstee, Quentin, Loomba, Rohit, Ratziu, Vlad, and Wack, Katy

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Good Health and Well Being, Public Health and Health Services, Gastroenterology & Hepatology, Clinical sciences
Published
2023

12. GS-001 Primary results from MAESTRO-NASH a pivotal phase 3 52-week serial liver biopsy study in 966 patients with NASH and fibrosis

Author

Harrison, Stephen, Bedossa, Pierre, Guy, Cynthia, Schattenberg, Jörn, Loomba, Rohit, Taub, Rebecca, Labriola, Dominic, Moussa, Sam, Neff, Guy, Sanyal, Arun, Noureddin, Mazen, Bansal, Meena, Alkhouri, Naim, and Ratziu, Vlad

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Public Health and Health Services, Gastroenterology & Hepatology, Clinical sciences
Published
2023

13. Semaglutide 2·4 mg once weekly in patients with non-alcoholic steatohepatitis-related cirrhosis: a randomised, placebo-controlled phase 2 trial

Author

Loomba, Rohit, Abdelmalek, Manal F, Armstrong, Matthew J, Jara, Maximilian, Kjær, Mette Skalshøi, Krarup, Niels, Lawitz, Eric, Ratziu, Vlad, Sanyal, Arun J, Schattenberg, Jörn M, Newsome, Philip N, and investigators, NN9931-4492

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Digestive Diseases, Clinical Research, Diabetes, Liver Disease, Clinical Trials and Supportive Activities, Hepatitis, Chronic Liver Disease and Cirrhosis, 6.1 Pharmaceuticals, Good Health and Well Being, Adult, Humans, Male, Female, Middle Aged, Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease, Glucagon-Like Peptide 1, Liver Cirrhosis, NN9931-4492 investigators, Clinical sciences
Abstract

BackgroundPatients with non-alcoholic steatohepatitis (NASH)-related cirrhosis are at high risk of liver-related and all-cause morbidity and mortality. We investigated the efficacy and safety of the glucagon-like peptide-1 analogue semaglutide in patients with NASH and compensated cirrhosis.MethodsThis double-blind, placebo-controlled phase 2 trial enrolled patients from 38 centres in Europe and the USA. Adults with biopsy-confirmed NASH-related cirrhosis and body-mass index (BMI) of 27 kg/m2 or more were randomly assigned (2:1) to receive either once-weekly subcutaneous semaglutide 2·4 mg or visually matching placebo. Patients were randomly allocated via an interactive web response system, stratified by presence or absence of type 2 diabetes. Patients, investigators, and those assessing outcomes were masked to treatment assignment. The primary endpoint was the proportion of patients with an improvement in liver fibrosis of one stage or more without worsening of NASH after 48 weeks, assessed by biopsy in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of study drug. The trial is closed and completed, and registered with ClinicalTrials.gov, number NCT03987451.Findings71 patients were enrolled between June 18, 2019, and April 22, 2021; 49 (69%) patients were female and 22 (31%) were male. Patients had a mean age of 59·5 years (SD 8·0) and mean BMI of 34·9 kg/m2 (SD 5·9); 53 (75%) patients had diabetes. 47 patients were randomly assigned to the semaglutide group and 24 to the placebo group. After 48 weeks, there was no statistically significant difference between the two groups in the proportion of patients with an improvement in liver fibrosis of one stage or more without worsening of NASH (five [11%] of 47 patients in the semaglutide group vs seven [29%] of 24 in the placebo group; odds ratio 0·28 [95% CI 0·06-1·24; p=0·087). There was also no significant difference between groups in the proportion of patients who achieved NASH resolution (p=0·29). Similar proportions of patients in each group reported adverse events (42 [89%] patients in the semaglutide group vs 19 [79%] in the placebo group) and serious adverse events (six [13%] vs two [8%]). The most common adverse events were nausea (21 [45%] vs four [17%]), diarrhoea (nine [19%] vs two [8%]), and vomiting (eight [17%] vs none). Hepatic and renal function remained stable. There were no decompensating events or deaths.InterpretationIn patients with NASH and compensated cirrhosis, semaglutide did not significantly improve fibrosis or achievement of NASH resolution versus placebo. No new safety concerns were raised.FundingNovo Nordisk A/S.

Published
2023

14. Designing an exploratory phase 2b platform trial in NASH with correlated, co-primary binary endpoints

Author

Meyer, Elias Laurin, Mesenbrink, Peter, Di Prospero, Nicholas A., Pericàs, Juan M., Glimm, Ekkehard, Ratziu, Vlad, Sena, Elena, and König, Franz

Subjects
Statistics - Applications
Abstract

Non-alcoholic steatohepatitis (NASH) is the progressive form of nonalcoholic fatty liver disease (NAFLD) and a disease with high unmet medical need. Platform trials provide great benefits for sponsors and trial participants in terms of accelerating drug development programs. In this article, we describe some of the activities of the EU-PEARL consortium (EU Patient-cEntric clinicAl tRial pLatforms) regarding the use of platform trials in NASH, in particular the proposed trial design, decision rules and simulation results. For a set of assumptions, we present the results of a simulation study recently discussed with two health authorities and the learnings from these meetings from a trial design perspective. Since the proposed design uses co-primary binary endpoints, we furthermore discuss the different options and practical considerations for simulating correlated binary endpoints.

Published
2022
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15. TOPLINE RESULTS FROM A NEW ANALYSIS OF THE REGENERATE TRIAL OF OBETICHOLIC ACID FOR THE TREATMENT OF NONALCOHOLIC STEATOHEPATITIS

Author

Sanyal, Arun J, Loomba, Rohit, Anstee, Quentin M, Ratziu, Vlad, Kowdley, Kris V, Rinella, Mary E, Sheikh, Muhammad Y, Trotter, James F, Knapple, Whitfield L, Lawitz, Eric J, Abdelmalek, Manal F, Newsome, Philip N, Hansen, Bettina E, Mathurin, Philippe, Dufour, Jean-Francois, Berrey, M Michelle, Shiff, Steven J, Sawhney, Sangeeta, Capozza, Thomas, Leyva, Rina, Harrison, Stephen A, and Younossi, Zobair M

Subjects
Medical Biochemistry and Metabolomics, Clinical Sciences, Immunology, Gastroenterology & Hepatology, Clinical sciences
Published
2023

16. Reliability of histologic assessment for NAFLD and development of an expanded NAFLD activity score

Author

Pai, Rish K, Jairath, Vipul, Hogan, Malcolm, Zou, Guangyong, Adeyi, Oyedele A, Anstee, Quentin M, Aqel, Bashar A, Behling, Cynthia, Carey, Elizabeth J, Clouston, Andrew D, Corey, Kathleen, Feagan, Brian G, Kleiner, David E, Ma, Christopher, McFarlane, Stefanie C, Noureddin, Mazen, Ratziu, Vlad, Valasek, Mark A, Younossi, Zobair M, Harrison, Stephen A, and Loomba, Rohit

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Digestive Diseases, Chronic Liver Disease and Cirrhosis, Clinical Research, Liver Disease, Hepatitis, Biopsy, Fibrosis, Humans, Liver, Non-alcoholic Fatty Liver Disease, Reproducibility of Results, Severity of Illness Index, Medical Biochemistry and Metabolomics, Immunology, Gastroenterology & Hepatology, Clinical sciences
Abstract

Background and aimsThe NASH Clinical Research Network histologic scoring system, the gold-standard NASH histology assessment for clinical trials, has demonstrated intrarater and interrater variability. An expert panel in a previous systematic Research and Development/University of California Los Angeles (RAND/UCLA) study determined that existing histologic scoring systems do not fully capture NASH disease activity and fibrosis, and standardized definitions of histologic features are needed. We evaluated the reliability of existing and alternate histologic measures and their correlations with a disease activity visual analog scale to propose optimal components for an expanded NAFLD activity score (NAS).Approach and resultsFour liver pathologists who were involved in the prior RAND/UCLA study underwent standardized training and multiple discussions with the goal of improving agreement. They were blinded to clinical information and scored histologic measures twice, ≥2 weeks apart, for 40 liver biopsies representing the full spectrum of NAFLD. Index intraclass correlation coefficient (ICC) estimates demonstrated intrarater (0.80-0.85) and interrater (0.60-0.72) reliability. Hepatocyte ballooning items had similar interrater ICCs (0.68-0.79), including those extending scores from 0-2 to 0-4. Steatosis measures (interrater ICCs, 0.72-0.80) correlated poorly with disease activity. Correlations with disease activity were largest for hepatocyte ballooning and Mallory-Denk bodies (MDBs), with both used to develop the expanded NAS (intrarater ICC, 0.90; interrater ICC, 0.80). Fibrosis measures had ICCs of 0.70-0.87.ConclusionsAfter extensive preparation among a group of experienced pathologists, we demonstrated improved reliability of multiple existing histologic NAFLD indices and fibrosis staging systems. Hepatocyte ballooning and MDBs most strongly correlated with disease activity and were used for the expanded NAS. Further validation including evaluation of responsiveness is required.

Published
2022

19. Treatment with bulevirtide in HIV-infected patients with chronic hepatitis D: ANRS HD EP01 BuleDelta and compassionate cohort

Author

Raffi, François, Alric, Laurent, Miailhes, Patrick, Tran, Albert, Stern, Christiane, Causse, Xavier, Tripon, Simona, Riachi, Ghassan, Chazouillères, Olivier, Abergel, Armando, d’Alteroche, Louis, Gournay, Jérôme, Lagadic, Garance, Carrieri, Patrizia, Brichler, Ségolène, Siguier, Martin, Krause, Jessica, Foucher, Juliette, Ben Ali, Souad, Meszaros, Magdalena, Varaut, Anne, Canva, Valérie, de Lédinghen, Victor, Fougerou-Leurent, Claire, Le Pabic, Estelle, Pol, Stanislas, Alfaiate, Dulce, Lacombe, Karine, Hilleret, Marie-Noëlle, Lascoux-Combe, Caroline, Minello, Anne, Billaud, Eric, Rosa, Isabelle, Gervais, Anne, Ratziu, Vlad, Ganne, Nathalie, Pageaux, Georges-Philippe, Leroy, Vincent, Loustaud-Ratti, Véronique, Mathurin, Philippe, Chas, Julie, Jezequel, Caroline, Métivier, Sophie, Dumortier, Jérôme, Arpurt, Jean-Pierre, Asselah, Tarik, Roche, Bruno, Le Gruyer, Antonia, Valantin, Marc-Antoine, Scholtès, Caroline, Gordien, Emmanuel, Tual, Christelle, Kortebi, Amel, Coulibaly, Fatoumata, Rosenthal, Eric, Subic-Levrero, Miroslava, Roulot, Dominique, and Zoulim, Fabien

Published
2024
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20. Effect of Peg-IFN on the viral kinetics of patients with HDV infection treated with bulevirtide

Author

El Messaoudi, Selma, Brichler, Ségolène, Fougerou-Leurent, Claire, Gordien, Emmanuel, Gerber, Athenaïs, Kortebi, Amal, Lagadic, Garance, Subic-Levrero, Miroslava, Metivier, Sophie, Pol, Stanislas, Minello, Anne, Ratziu, Vlad, Leroy, Vincent, Mathurin, Philippe, Alric, Laurent, Coulibaly, Fatoumata, Pawlotsky, Jean-Michel, Zoulim, Fabien, de Lédinghen, Victor, and Guedj, Jérémie

Published
2024
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22. Expert Panel Review to Compare FDA and EMA Guidance on Drug Development and Endpoints in Nonalcoholic Steatohepatitis

Author

Loomba, Rohit, Ratziu, Vlad, Harrison, Stephen A, McFarlane, Stefanie C, Tamaki, Nobuharu, Abdelmalek, Manal F, Rinella, Mary E, Anstee, Quentin M, Younossi, Zobair M, Sanyal, Arun, and Jairath, Vipul

Subjects
Clinical Trials as Topic, Drug Development, Europe, Humans, Non-alcoholic Fatty Liver Disease, Severity of Illness Index, United States, United States Food and Drug Administration, NASH Clinical Trial Design International Working Group, Clinical Sciences, Neurosciences, Paediatrics and Reproductive Medicine, Gastroenterology & Hepatology
Published
2022

24. TVB-2640 (FASN Inhibitor) for the Treatment of Nonalcoholic Steatohepatitis: FASCINATE-1, a Randomized, Placebo-Controlled Phase 2a Trial

Author

Loomba, Rohit, Mohseni, Rizwana, Lucas, K Jean, Gutierrez, Julio A, Perry, Robert G, Trotter, James F, Rahimi, Robert S, Harrison, Stephen A, Ajmera, Veeral, Wayne, Jeffrey D, O'Farrell, Marie, McCulloch, William, Grimmer, Katharine, Rinella, Mary, Wai-Sun Wong, Vincent, Ratziu, Vlad, Gores, Gregory J, Neuschwander-Tetri, Brent A, and Kemble, George

Subjects
Clinical Trials and Supportive Activities, Nutrition, Clinical Research, Hepatitis, Liver Disease, Digestive Diseases, Chronic Liver Disease and Cirrhosis, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Oral and gastrointestinal, Adult, Biomarkers, Enzyme Inhibitors, Fatty Acid Synthase, Type I, Female, Humans, Lipids, Lipogenesis, Liver, Liver Cirrhosis, Male, Middle Aged, Nitriles, Non-alcoholic Fatty Liver Disease, Piperidines, Single-Blind Method, Time Factors, Treatment Outcome, Triazoles, United States, Palmitate, PRO-C3, Clinical Sciences, Neurosciences, Paediatrics and Reproductive Medicine, Gastroenterology & Hepatology
Abstract

Background & aimsIncreased de novo lipogenesis creates excess intrahepatic fat and lipotoxins, propagating liver damage in nonalcoholic steatohepatitis. TVB-2640, a fatty acid synthase inhibitor, was designed to reduce excess liver fat and directly inhibit inflammatory and fibrogenic pathways. We assessed the safety and efficacy of TVB-2640 in patients with nonalcoholic steatohepatitis in the United States.Methods3V2640-CLIN-005 (FASCINATE-1) was a randomized, placebo-controlled, single-blind study at 10 US sites. Adults with ≥8% liver fat, assessed by magnetic resonance imaging proton density fat fraction, and evidence of liver fibrosis by magnetic resonance elastography ≥2.5 kPa or liver biopsy were eligible. Ninety-nine patients were randomized to receive placebo or 25 mg or 50 mg of TVB-2640 (orally, once-daily for 12 weeks). The primary end points of this study were safety and relative change in liver fat after treatment.ResultsLiver fat increased in the placebo cohort by 4.5% relative to baseline; in contrast TVB-2640 reduced liver fat by 9.6% in the 25-mg cohort (n = 30; least squares mean: -15.5%; 95% confidence interval, -31.3 to -0.23; P = .053), and 28.1% in the 50-mg cohort (n = 28; least squares mean: -28.0%; 95% confidence interval, -44.5 to -11.6; P = .001). Eleven percent of patients in the placebo group achieved a ≥30% relative reduction of liver fat compared to 23% in the 25-mg group, and 61% in the 50-mg group (P < .001). Secondary analyses showed improvements of metabolic, pro-inflammatory and fibrotic markers. TVB-2640 was well tolerated; adverse events were mostly mild and balanced among the groups.ConclusionsTVB-2640 significantly reduced liver fat and improved biochemical, inflammatory, and fibrotic biomarkers after 12 weeks, in a dose-dependent manner in patients with nonalcoholic steatohepatitis. ClinicalTrials.gov, Number NCT03938246.

Published
2021

27. Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL

Author

Sánchez-Montalva, Adrian, Estevez, Ana Belén, Sánchez, Àlex, Sanjuan, Anna, Sena, Elena, Granados, Emma, Arévalo de Andrés, Esther, Nuñez, Fátima, Arteaga, Gara, Fuentes Ruiz, Gabriela Perez, Fernández, Guillermo, Rivera-Esteban, Jesus, Comella, Joan, Ramos-Quiroga, Josep Antoni, Genescà, Joan, Espinosa, Juan, Pericàs, Juan Manuel, Murcia, Lada, Cash-Gibson, Lucinda, de Valles Silvosa, Maria, Barroso de Sousa, María Fernanda, Sánchez-Maroto Carrizo, Olga, Ibañez-Jiménez, Pol, Augustin, Salvador, Perez-Hoyos, Santiago, Rodríguez-Navarro, Sarai, Muñoz-Martínez, Sergio, Serres, Silvia, Kalko, Susana, Michon, Amelie, Ussi, Anton, Lydall, Ben, van de Ketterij, Edwin, Quiles, Ignacio, Carapina, Tamara, Kumaus, Constantin, Ramazanova, Dariga, Meyer, Elias Laurin, Koenig, Franz, Roig, Marta Bofill, Brunner, Martin, Posch, Martin, Krotka, Pavla, Zehetmayer, Sonja, Carton, Charlotte, Legius, Eric, Begum, Amina, Pariante, Carmine, Worrell, Courtney, Lombardo, Giulia, Sforzini, Luca, Brown, Mollie, Gullet, Nancy, Amasi-Hartoonian, Nare, Ferner, Rosalie, Kose, Melisa, Spitaleri, Andrea, Ghodousi, Arash, Di Serio, Clelia, Cirillo, Daniela, Cugnata, Federica, Saluzzo, Francesca, Benedetti, Francesco, Scarale, Maria Giovanna, Zini, Michela, Rancoita, Paola Maria, Alagna, Riccardo, Poletti, Sara, Dhaenens, Britt, Van Der Lei, Johan, de Steenwinkel, Jurriaan, Moinat, Maxim, Oostenbrink, Rianne, Hoogendijk, Witte, Hölscher, Michael, Heinrich, Norbert, Otte, Christian, Potratz, Cornelia, Zocholl, Dario, Kulakova, Eugenia, Tacke, Frank, Brasanac, Jelena, Leubner, Jonas, Krajewska, Maja, Freitag, Michaela Maria, Gold, Stefan, Zoller, Thomas, Chae, Woo Ri, Daniel, Christel, Kara, Leila, Vaterkowski, Morgan, Griffon, Nicolas, Wolkenstein, Pierre, Pais, Raluca, Ratziu, Vlad, Voets, David, Maes, Christophe, Kalra, Dipak, Thienpoint, Geert, Deckerck, Jens, Lea, Nathan, Singleton, Peter, Viele, Kert, Jacko, Peter, Berry, Scott, Parke, Tom, Aydin, Burç, Kubiak, Christine, Demotes, Jacques, Ueda, Keiko, Matei, Mihaela, Contrino, Sergio, Röhl, Claas, Cordero, Estefania, Greenhalgh, Fiona, Jarke, Hannes, Angelova, Juliana, Boudes, Mathieu, Dressler, Stephan, Strammiello, Valentina, Anstee, Quentin, Gutierrez-Ibarluzea, Iñaki, Otte, Maximilian, Heimbach, Natalie, Hofner, Benjamin, Burgwinkel, Cora, Kaestel, Hue, Hees, Katharina, Nguyen, Quynh, Prieto-Alhambra, Daniel, Tan, Eng Hooi (Cheryl), Raviglione, Mario, de Colombani, Pierpaolo, Villa, Simone, Maron, Eduard, Evans, Gareth, Savitz, Adam J., Van Dessel, Ann, Duca, Anna, Kaminski, Anne, Wouters, Bie, Porter, Brandon, Charron, Catherine, Spiertz, Cecile, Zizzamia, Christopher, Millar, Daniel, Hasselbaink, Danny, Orr, David, Kesters, Divya, Hubin, Ellen, Davies, Emma, Didden, Eva-Maria, Guz, Gabriela, Verstraete, Evelyn, Mao, Gary, Capuano, George, Martynowicz, Heddie, De Smedt, Heidi, Larsson, Ingela, Bruegelmans, Ines, Coste, Isabelle, Gonzalez Moreno, Jesus Maria, Niewczas, Julia, Xu, Jiajun, Rombouts, Karin, Woo, Katherine, Wuyts, Kathleen, Hersh, Kathryn, Oldenburg, Khrista, Zhang, Lingjiao, Schmidt, Mark, Szuch, Mark, Todorovic, Marija, Mangelaars, Maartje, Grewal, Melissa, Sandor, Molli, Di Prospero, Nick, Van Houten, Pamela, Minnick, Pansy, Bastos, Polyana, Patrizi, Robert, Morello, Salvatore, De Wilde, Severijn, Sun, Tao, Kline, Timothy, de Marez, Tine, Mielke, Tobias, Reijns, Tom, Popova, Vanina, Flossbach, Yanina, Tymofyeyev, Yevgen, De Groote, Zeger, Sverdlov, Alex, Bobirca, Alexandra, Krause, Annekatrin, Bobrica, Catalin, Heintz, Daniela, Magirr, Dominic, Glimm, Ekkehard, Baffert, Fabienne, Castiglione, Federica, Caruso, Franca, Patalano, Francesco, Bretz, Frank, Heimann, Guenter, Carbarns, Ian, Rodríguez, Ignacio, Ratescu, Ioana, Hampson, Lisa, Pedrosa, Marcos, Hark, Mareile, Mesenbrink, Peter, Penna, Sabina Hernandez, Bergues-Lang, Sarah, Baltes-Engler, Susanne, Arsiwala, Tasneem, Mondragon, Valeria Jordan, Guo, Hua, Da Costa, Jose Leite, Burman, Carl-Fredrik, Kirk, George, Aaes-Jørgensen, Anders, Dirach, Jorgen, Kjær, Mette Skalshøi, Martin, Alexandra, Hristov, Diyan, Rousseaux, Florent, Hittel, Norbert, Dornheim, Robert, Evans, Daniel, Sykes, Nick, Couvert, Camille, Leuven, Catherine, Notelet, Loïc, Gidh-Jain, Madhavi, Jouannin, Mathieu, Ammour, Nadir, Pierre, Suzanne, Haufe, Volker, Dong, Yingwen, Dubanchet, Catherine, de Préville, Nathalie, Baltauss, Tania, Jian, Zhu, Shnider, Sara, Bar-El, Tal, Bakker, Annette, Nievo, Marco, Iloeje, Uche, Conradie, Almari, Auffarrth, Ece, Lombard, Leandra, Benhayoun, Majda, Olugbosi, Morounfolu, Seidel, Stephanie S., Gumí, Berta, Guzmán, Claudia García, Molero, Eva, Pairó, Gisela, Machin, Núria, Cardelús, Raimon, Ramasastry, Saira, Pelzer, Saskia, Kremer, Andreas, Lindfors, Erno, Lynch, Chris, Spiertz, Cécile, Machín, Núria, and Pericàs, Juan M.

Published
2024
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28. A multisociety Delphi consensus statement on new fatty liver disease nomenclature

Author

Rinella, Mary E., Lazarus, Jeffrey V., Ratziu, Vlad, Francque, Sven M., Sanyal, Arun J., Kanwal, Fasiha, Romero, Diana, Abdelmalek, Manal F., Anstee, Quentin M., Arab, Juan Pablo, Arrese, Marco, Bataller, Ramon, Beuers, Ulrich, Boursier, Jerome, Bugianesi, Elisabetta, Byrne, Christopher D., Narro, Graciela E. Castro, Chowdhury, Abhijit, Cortez-Pinto, Helena, Cryer, Donna R., Cusi, Kenneth, El-Kassas, Mohamed, Klein, Samuel, Eskridge, Wayne, Fan, Jiangao, Gawrieh, Samer, Guy, Cynthia D., Harrison, Stephen A., Kim, Seung Up, Koot, Bart G., Korenjak, Marko, Kowdley, Kris V., Lacaille, Florence, Loomba, Rohit, Mitchell-Thain, Robert, Morgan, Timothy R., Powell, Elisabeth E., Roden, Michael, Romero-Gómez, Manuel, Silva, Marcelo, Singh, Shivaram Prasad, Sookoian, Silvia C., Spearman, C. Wendy, Tiniakos, Dina, Valenti, Luca, Vos, Miriam B., Wong, Vincent Wai-Sun, Xanthakos, Stavra, Yilmaz, Yusuf, Younossi, Zobair, Hobbs, Ansley, Villota-Rivas, Marcela, and Newsome, Philip N.

Published
2024
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31. Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS): Assessment & validation of imaging modality performance across the NAFLD spectrum in a prospectively recruited cohort study (the LITMUS imaging study): Study protocol

Author

Pavlides, Michael, Mózes, Ferenc E., Akhtar, Salma, Wonders, Kristy, Cobbold, Jeremy, Tunnicliffe, Elizabeth M., Allison, Michael, Godfrey, Edmund M., Aithal, Guruprasad P., Francis, Susan, Romero-Gomez, Manuel, Castell, Javier, Fernandez-Lizaranzu, Isabel, Aller, Rocio, González, Rebeca Sigüenza, Agustin, Salvador, Pericàs, Juan M., Boursier, Jerome, Aube, Christophe, Ratziu, Vlad, Wagner, Mathilde, Petta, Salvatore, Antonucci, Michela, Bugianesi, Elisabetta, Faletti, Riccardo, Miele, Luca, Geier, Andreas, Schattenberg, Jörn M., Tilman, Emrich, Ekstedt, Mattias, Lundberg, Peter, Berzigotti, Annalisa, Huber, Adrian T., Papatheodoridis, George, Yki-Järvinen, Hannele, Porthan, Kimmo, Schneider, Moritz Jörg, Hockings, Paul, Shumbayawonda, Elizabeth, Banerjee, Rajarshi, Pepin, Kay, Kalutkiewicz, Mike, Ehman, Richard L., Trylesinksi, Aldo, Coxson, Harvey O., Martic, Miljen, Yunis, Carla, Tuthill, Theresa, Bossuyt, Patrick M., Anstee, Quentin M., Neubauer, Stefan, and Harrison, Stephen

Published
2023
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32. Results from a new efficacy and safety analysis of the REGENERATE trial of obeticholic acid for treatment of pre-cirrhotic fibrosis due to non-alcoholic steatohepatitis

Author

Sanyal, Arun J., Ratziu, Vlad, Loomba, Rohit, Anstee, Quentin M., Kowdley, Kris V., Rinella, Mary E., Sheikh, Muhammad Y., Trotter, James F., Knapple, Whitfield, Lawitz, Eric J., Abdelmalek, Manal F., Newsome, Philip N., Boursier, Jérôme, Mathurin, Philippe, Dufour, Jean-François, Berrey, M. Michelle, Shiff, Steven J., Sawhney, Sangeeta, Capozza, Thomas, Leyva, Rina, Harrison, Stephen A., and Younossi, Zobair M.

Published
2023
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33. A global research priority agenda to advance public health responses to fatty liver disease

Author

Lazarus, Jeffrey V., Mark, Henry E., Allen, Alina M., Arab, Juan Pablo, Carrieri, Patrizia, Noureddin, Mazen, Alazawi, William, Alkhouri, Naim, Alqahtani, Saleh A., Arrese, Marco, Bataller, Ramon, Berg, Thomas, Brennan, Paul N., Burra, Patrizia, Castro-Narro, Graciela E., Cortez-Pinto, Helena, Cusi, Kenneth, Dedes, Nikos, Duseja, Ajay, Francque, Sven M., Hagström, Hannes, Huang, Terry T-K., Wajcman, Dana Ivancovsky, Kautz, Achim, Kopka, Christopher J., Krag, Aleksander, Miller, Veronica, Newsome, Philip N., Rinella, Mary E., Romero, Diana, Sarin, Shiv Kumar, Silva, Marcelo, Spearman, C. Wendy, Tsochatzis, Emmanuel A., Valenti, Luca, Villota-Rivas, Marcela, Zelber-Sagi, Shira, Schattenberg, Jörn M., Wong, Vincent Wai-Sun, Younossi, Zobair M., Aberg, Fredrik, Adams, Leon, Al-Naamani, Khalid, Albadawy, Reda M., Alexa, Zinaida, Allison, Michael, Alnaser, Faisal A., Alswat, Khalid, Alvares-da-Silva, Mario Reis, Alvaro, Domenico, Alves-Bezerra, Michele, Andrade, Raul J., Anstee, Quentin M., Awuku, Yaw Asante, Baatarkhuu, Oidov, Baffy, Gyorgy, Bakieva, Shokhista, Bansal, Meena B., Barouki, Robert, Batterham, Rachel L., Behling, Cynthia, Belfort-DeAguiar, Renata, Berzigotti, Annalisa, Betel, Michael, Bianco, Cristiana, Bosi, Emanuele, Boursier, Jerome, Brunt, Elizabeth M., Bugianesi, Elisabetta, Byrne, Christopher J., Cabrera Cabrejos, Maria Cecilia, Caldwell, Stephen, Carr, Rotonya, Castellanos Fernández, Marlen Ivón, Castera, Laurent, Castillo-López, Maria Gabriela, Caussy, Cyrielle, Cerda-Reyes, Eira, Ceriello, Antonio, Chan, Wah- Kheong, Chang, Yoosoo, Charatcharoenwitthaya, Phunchai, Chavez-Tapia, Norberto, Chung, Raymond T., Colombo, Massimo, Coppell, Kirsten, Cotrim, Helma P., Craxi, Antonio, Crespo, Javier, Dassanayake, Anuradha, Davidson, Nicholas O., De Knegt, Robert, de Ledinghen, Victor, Demir, Münevver, Desalegn, Hailemichael, Diago, Moises, Dillon, John F., Dimmig, Bruce, Dirac, M. Ashworth, Dirchwolf, Melisa, Dufour, Jean-François, Dvorak, Karel, Ekstedt, Mattias, El-Kassas, Mohamed, Elsanousi, Osama M., Elsharkawy, Ahmed M., Elwakil, Reda, Eskridge, Wayne, Eslam, Mohammed, Esmat, Gamal, Fan, Jian- Gao, Ferraz, Maria Lucia, Flisiak, Robert, Fortin, Davide, Fouad, Yasser, Freidman, Scott L., Fuchs, Michael, Gadano, Adrian, Gastaldelli, Amalia, Geerts, Anja, Geier, Andreas, George, Jacob, Gerber, Lynn H., Ghazinyan, Hasmik, Gheorghe, Liana, Kile, Denise Giangola, Girala, Marcos, Boon Bee, George Goh, Goossens, Nicolas, Graupera, Isabel, Grønbæk, Henning, Hamid, Saeed, Hebditch, Vanessa, Henry, Zachary, Hickman, Ingrid J., Hobbs, L. Ansley, Hocking, Samantha L., Hofmann, Wolf Peter, Idilman, Ramazan, Iruzubieta, Paula, Isaacs, Scott, Isakov, Vasily A., Ismail, Mona H., Jamal, Mohammad H., Jarvis, Helen, Jepsen, Peter, Jornayvaz, François, Sudhamshu, K.C., Kakizaki, Satoru, Karpen, Saul, Kawaguchi, Takumi, Keating, Shelley E., Khader, Yousef, Kim, Seung Up, Kim, Won, Kleiner, David E., Koek, Ger, Joseph Komas, Narcisse Patrice, Kondili, Loreta A., Koot, Bart G., Korenjak, Marko, Kotsiliti, Eleni, Koulla, Yiannoula, Kugelmas, Carina, Kugelmas, Marcelo, Labidi, Asma, Lange, Naomi F., Lavine, Joel E., Lazo, Mariana, Leite, Nathalie, Lin, Han-Chieh, Lkhagvaa, Undram, Long, Michelle T., Lopez-Jaramillo, Patricio, Lozano, Adelina, Macedo, Maria Paula, Malekzadeh, Reza, Marchesini, Giulio, Marciano, Sebastian, Martinez, Kim, Martínez Vázquez, Sophia E., Mateva, Lyudmila, Mato, José M., Nlombi, Charles Mbendi, McCary, Alexis Gorden, McIntyre, Jeff, McKee, Martin, Mendive, Juan M., Mikolasevic, Ivana, Miller, Pamela S., Milovanovic, Tamara, Milton, Terri, Moreno-Alcantar, Rosalba, Morgan, Timothy R., Motala, Ayesha, Muris, Jean, Musso, Carla, Nava-González, Edna J., Negro, Francesco, Nersesov, Alexander V., Neuschwander-Tetri, Brent A., Nikolova, Dafina, Norris, Suzanne, Novak, Katja, Ocama, Ponsiano, Ong, Janus P., Ong-Go, Arlinking, Onyekwere, Charles, Padilla, Martin, Pais, Raluca, Pan, Calvin, Panduro, Arturo, Panigrahi, Manas K., Papatheodoridis, Georgios, Paruk, Imran, Patel, Keyur, Gonçalves, Carlos Penha, Figueroa, Marlene Pérez, Pérez-Escobar, Juanita, Pericàs, Juan M., Perseghin, Gianluca, Pessoa, Mário Guimarães, Petta, Salvatore, Marques Souza de Oliveira, Claudia Pinto, Prabhakaran, Dorairaj, Pyrsopoulous, Nikolaos, Rabiee, Atoosa, Ramji, Alnoor, Ratziu, Vlad, Ravendhran, Natarajan, Ray, Katrina, Roden, Michael, Romeo, Stefano, Romero-Gómez, Manuel, Rotman, Yaron, Rouabhia, Samir, Rowe, Ian A., Sadirova, Shakhlo, Alkhatry, Maryam Salem, Salupere, Riina, Satapathy, Sanjaya K., Schwimmer, Jeffrey B., Sebastiani, Giada, Seim, Lynn, Seki, Yosuke, Serme, Abdel Karim, Shapiro, David, Sharvadze, Lali, Shaw, Jonathan E., Shawa, Isaac Thom, Shenoy, Thrivikrama, Shibolet, Oren, Shimakawa, Yusuke, Shubrook, Jay H., Singh, Shivaram Prasad, Sinkala, Edford, Skladany, Lubomir, Skrypnyk, Igor, Song, Myeong Jun, Sookoian, Silvia, Sridharan, Kannan, Stefan, Norbert, Stine, Jonathan G., Stratakis, Nikolaos, Sheriff, Dhastagir Sultan, Sundaram, Shikha S., Svegliati-Baroni, Gianluca, Swain, Mark G., Tacke, Frank, Taheri, Shahrad, Tan, Soek-Siam, Tapper, Elliot B., Targher, Giovanni, Tcaciuc, Eugen, Thiele, Maja, Tiniakos, Dina, Tolmane, Ieva, Torre, Aldo, Torres, Esther A., Treeprasertsuk, Sombat, Trenell, Michael, Turcan, Svetlana, Turcanu, Adela, Valantinas, Jonas, van Kleef, Laurens A., Velarde Ruiz Velasco, Jose Antonio, Vesterhus, Mette, Vilar-Gomez, Eduardo, Waked, Imam, Wattacheril, Julia, Wedemeyer, Heiner, Wilkins, Fonda, Willemse, José, Wong, Robert J., Yilmaz, Yusuf, Yki-Järvinen, Hannele, Yu, Ming-Lung, Yumuk, Volkan, Zeybel, Müjdat, Zheng, Kenneth I., Zheng, Ming-Hua, and Huang, Terry T.-K.

Published
2023
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36. Tropifexor for nonalcoholic steatohepatitis: an adaptive, randomized, placebo-controlled phase 2a/b trial

Author

Sanyal, Arun J., Lopez, Patricia, Lawitz, Eric J., Lucas, Kathryn J., Loeffler, Juergen, Kim, Won, Goh, George B. B., Huang, Jee-Fu, Serra, Carla, Andreone, Pietro, Chen, Yi-Cheng, Hsia, Stanley H., Ratziu, Vlad, Aizenberg, Diego, Tobita, Hiroshi, Sheikh, Aasim M., Vierling, John M., Kim, Yoon Jun, Hyogo, Hideyuki, Tai, Dean, Goodman, Zachary, Schaefer, Felicity, Carbarns, Ian R. I., Lamle, Sophie, Martic, Miljen, Naoumov, Nikolai V., and Brass, Clifford A.

Published
2023
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37. Performance of non-invasive tests and histology for the prediction of clinical outcomes in patients with non-alcoholic fatty liver disease: an individual participant data meta-analysis

Author

Anstee, Quentin M, Daly, Ann K, Govaere, Olivier, Cockell, Simon, Tiniakos, Dina, Bedossa, Pierre, Burt, Alastair, Oakley, Fiona, Cordell, Heather J, Day, Christopher P, Wonders, Kristy, Missier, Paolo, McTeer, Matthew, Vale, Luke, Oluboyede, Yemi, Breckons, Matt, Bossuyt, Patrick M, Zafarmand, Hadi, Vali, Yasaman, Lee, Jenny, Nieuwdorp, Max, Holleboom, Adriaan G, Verheij, Joanne, Ratziu, Vlad, Clément, Karine, Patino-Navarrete, Rafael, Pais, Raluca, Paradis, Valerie, Schuppan, Detlef, Schattenberg, Jörn M, Surabattula, Rambabu, Myneni, Sudha, Straub, Beate K, Vidal-Puig, Toni, Vacca, Michele, Rodrigues-Cuenca, Sergio, Allison, Mike, Kamzolas, Ioannis, Petsalaki, Evangelia, Campbell, Mark, Lelliott, Chris J, Davies, Susan, Orešič, Matej, Hyötyläinen, Tuulia, McGlinchey, Aiden, Mato, Jose M, Millet, Óscar, Dufour, Jean-François, Berzigotti, Annalisa, Masoodi, Mojgan, Pavlides, Michael, Harrison, Stephen, Neubauer, Stefan, Cobbold, Jeremy, Mozes, Ferenc, Akhtar, Salma, Olodo-Atitebi, Seliat, Banerjee, Rajarshi, Kelly, Matt, Shumbayawonda, Elizabeth, Dennis, Andrea, Andersson, Anneli, Wigley, Ioan, Romero-Gómez, Manuel, Gómez-González, Emilio, Ampuero, Javier, Castell, Javier, Gallego-Durán, Rocío, Fernández, Isabel, Montero-Vallejo, Rocío, Karsdal, Morten, Rasmussen, Daniel Guldager Kring, Leeming, Diana Julie, Sinisi, Antonia, Musa, Kishwar, Sandt, Estelle, Tonini, Manuela, Bugianesi, Elisabetta, Rosso, Chiara, Armandi, Angelo, Marra, Fabio, Gastaldelli, Amalia, Svegliati, Gianluca, Boursier, Jérôme, Francque, Sven, Vonghia, Luisa, Driessen, Ann, Ekstedt, Mattias, Kechagias, Stergios, Yki-Järvinen, Hannele, Porthan, Kimmo, Arola, Johanna, van Mil, Saskia, Papatheodoridis, George, Cortez-Pinto, Helena, Rodrigues, Cecilia M P, Valenti, Luca, Pelusi, Serena, Petta, Salvatore, Pennisi, Grazia, Miele, Luca, Geier, Andreas, Trautwein, Christian, Reißing, Johanna, Aithal, Guruprasad P, Francis, Susan, Palaniyappan, Naaventhan, Bradley, Christopher, Hockings, Paul, Schneider, Moritz, Newsome, Philip, Hübscher, Stefan, Wenn, David, Rosenquist, Christian, Trylesinski, Aldo, Mayo, Rebeca, Alonso, Cristina, Duffin, Kevin, Perfield, James W, Chen, Yu, Yunis, Carla, Tuthill, Theresa, Harrington, Magdalena Alicia, Miller, Melissa, Chen, Yan, McLeod, Euan James, Ross, Trenton, Bernardo, Barbara, Schölch, Corinna, Ertle, Judith, Younes, Ramy, Oldenburger, Anouk, Coxson, Harvey, Ostroff, Rachel, Alexander, Leigh, Biegel, Hannah, Kjær, Mette Skalshøi, Harder, Lea Mørch, Davidsen, Peter, Ellegaard, Jens, Balp, Maria-Magdalena, Brass, Clifford, Jennings, Lori, Martic, Miljen, Löffler, Jürgen, Applegate, Douglas, Shankar, Sudha, Torstenson, Richard, Lindén, Daniel, Fournier-Poizat, Céline, Llorca, Anne, Kalutkiewicz, Michael, Pepin, Kay, Ehman, Richard, Horan, Gerald, Ho, Gideon, Tai, Dean, Chng, Elaine, Patterson, Scott D, Billin, Andrew, Doward, Lynda, Twiss, James, Thakker, Paresh, Derdak, Zoltan, Landgren, Henrik, Lackner, Carolin, Gouw, Annette, Hytiroglou, Prodromos, Mózes, Ferenc E, Lee, Jenny A, Alzoubi, Osama, Staufer, Katharina, Trauner, Michael, Paternostro, Rafael, Stauber, Rudolf E, van Dijk, Anne-Marieke, Mak, Anne Linde, de Saint Loup, Marc, Shima, Toshihide, Gaia, Silvia, Shalimar, Lupșor-Platon, Monica, Wong, Vincent Wai-Sun, Li, Guanlin, Wong, Grace Lai-Hung, Karlas, Thomas, Wiegand, Johannes, Sebastiani, Giada, Tsochatzis, Emmanuel, Liguori, Antonio, Yoneda, Masato, Nakajima, Atsushi, Hagström, Hannes, Akbari, Camilla, Hirooka, Masashi, Chan, Wah-Kheong, Mahadeva, Sanjiv, Rajaram, Ruveena, Zheng, Ming-Hua, George, Jacob, Eslam, Mohammed, Viganò, Mauro, Ridolfo, Sofia, Aithal, Guruprasad Padur, Lee, Dae Ho, Nasr, Patrik, Cassinotto, Christophe, de Lédinghen, Victor, Mendoza, Yuly P, Noureddin, Mazen, Truong, Emily, and Harrison, Stephen A

Published
2023
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38. Biomarkers for staging fibrosis and non-alcoholic steatohepatitis in non-alcoholic fatty liver disease (the LITMUS project): a comparative diagnostic accuracy study

Author

Vali, Yasaman, Lee, Jenny, Boursier, Jerome, Petta, Salvatore, Wonders, Kristy, Tiniakos, Dina, Bedossa, Pierre, Geier, Andreas, Francque, Sven, Allison, Mike, Papatheodoridis, Georgios, Cortez-Pinto, Helena, Pais, Raluca, Dufour, Jean-Francois, Leeming, Diana Julie, Harrison, Stephen A, Chen, Yu, Cobbold, Jeremy F, Pavlides, Michael, Holleboom, Adriaan G, Yki-Jarvinen, Hannele, Crespo, Javier, Karsdal, Morten, Ostroff, Rachel, Zafarmand, Mohammad Hadi, Torstenson, Richard, Duffin, Kevin, Yunis, Carla, Brass, Clifford, Ekstedt, Mattias, Aithal, Guruprasad P, Schattenberg, Jörn M, Bugianesi, Elisabetta, Romero-Gomez, Manuel, Ratziu, Vlad, Anstee, Quentin M, and Bossuyt, Patrick M

Published
2023
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42. NAFLD and NASH biomarker qualification in the LITMUS consortium – Lessons learned

Author

Rasmussen, Daniel Guldager Kring, Anstee, Quentin M., Torstenson, Richard, Golding, Bruno, Patterson, Scott D., Brass, Clifford, Thakker, Paresh, Harrison, Stephen, Billin, Andrew N., Schuppan, Detlef, Dufour, Jean-François, Andersson, Anneli, Wigley, Ioan, Shumbayawonda, Elizabeth, Dennis, Andrea, Schoelch, Corinna, Ratziu, Vlad, Yunis, Carla, Bossuyt, Patrick, and Karsdal, Morten Asser

Published
2023
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43. Screening HIV Patients at Risk for NAFLD Using MRI-PDFF and Transient Elastography: A European Multicenter Prospective Study

Author

Lemoine, Maud, Assoumou, Lambert, Girard, Pierre-Marie, Valantin, Marc Antoine, Katlama, Christine, De Wit, Stephane, Campa, Pauline, Rougier, Hayette, Meynard, Jean-Luc, Necsoi, Coca, Huefner, Anja D., Van Luzen, Jan, Schulze zur Wiesch, Julian, Bastard, Jean-Philippe, Fellahi, Soraya, Mauss, Stefan, Stankov, Metodi V., Baumgarten, Axel, Post, Gerrit, Serfaty, Lawrence, Ratziu, Vlad, Menu, Yves, Schlue, Jerome, Bedossa, Pierre, Capeau, Jacqueline, Costagliola, Dominique, Behrens, Georg, and Ingiliz, Patrick

Published
2023
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46. A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis

Author

Sanyal, Arun J., primary, Bedossa, Pierre, additional, Fraessdorf, Mandy, additional, Neff, Guy W., additional, Lawitz, Eric, additional, Bugianesi, Elisabetta, additional, Anstee, Quentin M., additional, Hussain, Samina Ajaz, additional, Newsome, Philip N., additional, Ratziu, Vlad, additional, Hosseini-Tabatabaei, Azadeh, additional, Schattenberg, Jörn M., additional, Noureddin, Mazen, additional, Alkhouri, Naim, additional, and Younes, Ramy, additional

Published
2024
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47. Bulevirtide Combined with Pegylated Interferon for Chronic Hepatitis D

Author

Asselah, Tarik, primary, Chulanov, Vladimir, additional, Lampertico, Pietro, additional, Wedemeyer, Heiner, additional, Streinu-Cercel, Adrian, additional, Pântea, Victor, additional, Lazar, Stefan, additional, Placinta, Gheorghe, additional, Gherlan, George S., additional, Bogomolov, Pavel, additional, Stepanova, Tatyana, additional, Morozov, Viacheslav, additional, Syutkin, Vladimir, additional, Sagalova, Olga, additional, Manuilov, Dmitry, additional, Mercier, Renee-Claude, additional, Ye, Lei, additional, Da, Ben L., additional, Chee, Grace, additional, Lau, Audrey H., additional, Osinusi, Anu, additional, Bourliere, Marc, additional, Ratziu, Vlad, additional, Pol, Stanislas, additional, Hilleret, Marie-Noëlle, additional, and Zoulim, Fabien, additional

Published
2024
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48. GS-006 Glucagon and GLP-1 receptor dual agonist survodutide improved liver histology in people with MASH and fibrosis: Results from a randomized, double-blind, placebo-controlled phase 2 trial

Author

Sanyal, Arun J, primary, Bedossa, Pierre, additional, Fraessdorf, Mandy, additional, Neff, Guy, additional, Lawitz, Eric, additional, Bugianesi, Elisabetta, additional, Anstee, Quentin M., additional, Hussain, Samina Ajaz, additional, Newsome, Philip N., additional, Ratziu, Vlad, additional, Hosseini-Tabatabaei, Azadeh, additional, Schattenberg, Jörn M, additional, Noureddin, Mazen, additional, Alkhouri, Naim, additional, and Younes, Ramy, additional

Published
2024
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50. LBO-002 Efruxifermin significantly reduced liver fibrosis in MASH patients with F2-F3 fibrosis, with sustained improvement in liver injury and resolution of steatohepatitis over 96 weeks (HARMONY phase 2b study)

Author

Harrison, Stephen A., primary, Frias, Juan P, additional, Neff, Guy, additional, Abrams, Gary, additional, Lucas, Kathryn Jean, additional, Sanchez, William, additional, Gogia, Sudhanshu, additional, Sheikh, Muhammad Y, additional, Behling, Cynthia, additional, Bedossa, Pierre, additional, Shao, Lan, additional, Chan, Doreen, additional, Fong, Erica, additional, de Temple, Brittany, additional, Minerva, Matthew, additional, Barrett, Kimberly, additional, Shringarpure, Reshma, additional, Tillman, Erik, additional, Rolph, Tim, additional, Cheng, Andrew, additional, Ratziu, Vlad, additional, and Yale, Kitty, additional

Published
2024
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