1. Tirzepatide for Weight Reduction in Chinese Adults With Obesity: The SURMOUNT-CN Randomized Clinical Trial.
- Author
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Zhao, Lin, Cheng, Zhifeng, Lu, Yibing, Liu, Ming, Chen, Hong, Zhang, Min, Wang, Rui, Yuan, Yuan, and Li, Xiaoying
- Subjects
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WEIGHT loss , *OBESITY , *BODY weight , *TERMINATION of treatment , *ADULTS , *WAIST-hip ratio - Abstract
Key Points: Question: What is the effect of once-weekly subcutaneous tirzepatide injection on body weight reduction in Chinese adults with obesity or overweight without diabetes? Findings: In this randomized clinical trial (N = 210), mean percent change in body weight at week 52 was −13.6% and −17.5% with tirzepatide 10 mg and 15 mg, respectively, compared with −2.3% with placebo; the differences between each tirzepatide group and the placebo group were statistically significant. Meaning: Among Chinese adults with obesity or overweight, tirzepatide resulted in greater reduction in body weight than placebo. Importance: Obesity has become a global public health concern and China has the largest number of affected people worldwide. Objective: To assess the efficacy and safety of treatment with tirzepatide for weight reduction in Chinese adults with obesity or overweight and weight-related comorbidities. Design, Setting, and Participants: This randomized, double-blind, placebo-controlled, phase 3 clinical trial conducted at 29 centers in China from September 2021 to December 2022 included Chinese adults (aged ≥18 years) with a body mass index (BMI) greater than or equal to 28 or greater than or equal to 24 and at least 1 weight-related comorbidity, excluding diabetes. Interventions: Participants were randomly assigned (1:1:1) to receive once-weekly, subcutaneous 10-mg (n = 70) or 15-mg (n = 71) tirzepatide or placebo (n = 69), plus a lifestyle intervention, for 52 weeks. Main Outcomes and Measures: Co–primary end points were the percent change in body weight from baseline and weight reduction of at least 5% at week 52. Efficacy and safety analyses were performed on an intention-to-treat population. Results: Of 210 randomized participants (103 [49.0%] female; mean [SD] age, 36.1 [9.1] years; body weight, 91.8 [16.0] kg; BMI, 32.3 [3.8]), 201 (95.7%) completed the trial. The mean change in body weight at week 52 was −13.6% (95% CI, −15.8% to −11.4%) with tirzepatide 10 mg, −17.5% (95% CI, −19.7% to −15.3%) with tirzepatide 15 mg, and −2.3% with placebo (difference between 10 mg and placebo, −11.3% [95% CI, −14.3% to −8.3%; P <.001]; difference between 15 mg and placebo, −15.1% [95% CI, −18.2% to −12.1%; P <.001]). The percentage of participants achieving body weight reductions of 5% or greater was 87.7% with tirzepatide 10 mg, 85.8% with tirzepatide 15 mg, and 29.3% with placebo (P <.001 for comparisons with placebo). The most frequent treatment-emergent adverse events with tirzepatide were gastrointestinal. Most were mild to moderate in severity, with few events leading to treatment discontinuation (<5%). Conclusions and Relevance: In Chinese adults with obesity or overweight, once-weekly treatment with tirzepatide 10 mg or 15 mg resulted in statistically significant and clinically meaningful weight reduction with an acceptable safety profile. Trial Registration: ClinicalTrials.gov Identifier: NCT05024032 This randomized clinical trial investigates the safety and efficacy of treatment with once-weekly tirzepatide for weight reduction in Chinese adults with overweight or obesity without diabetes over a 52-week period. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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