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Once-Weekly Semaglutide in Adults with Overweight or Obesity
- Source :
- NEW ENGLAND JOURNAL OF MEDICINE, The New England journal of medicine
- Publication Year :
- 2021
- Publisher :
- Massachusetts Medical Society, 2021.
-
Abstract
- Obesity is a global health challenge with few pharmacologic options. Whether adults with obesity can achieve weight loss with once-weekly semaglutide at a dose of 2.4 mg as an adjunct to lifestyle intervention has not been confirmed.In this double-blind trial, we enrolled 1961 adults with a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or greater (≥27 in persons with ≥1 weight-related coexisting condition), who did not have diabetes, and randomly assigned them, in a 2:1 ratio, to 68 weeks of treatment with once-weekly subcutaneous semaglutide (at a dose of 2.4 mg) or placebo, plus lifestyle intervention. The coprimary end points were the percentage change in body weight and weight reduction of at least 5%. The primary estimand (a precise description of the treatment effect reflecting the objective of the clinical trial) assessed effects regardless of treatment discontinuation or rescue interventions.The mean change in body weight from baseline to week 68 was -14.9% in the semaglutide group as compared with -2.4% with placebo, for an estimated treatment difference of -12.4 percentage points (95% confidence interval [CI], -13.4 to -11.5; P0.001). More participants in the semaglutide group than in the placebo group achieved weight reductions of 5% or more (1047 participants [86.4%] vs. 182 [31.5%]), 10% or more (838 [69.1%] vs. 69 [12.0%]), and 15% or more (612 [50.5%] vs. 28 [4.9%]) at week 68 (P0.001 for all three comparisons of odds). The change in body weight from baseline to week 68 was -15.3 kg in the semaglutide group as compared with -2.6 kg in the placebo group (estimated treatment difference, -12.7 kg; 95% CI, -13.7 to -11.7). Participants who received semaglutide had a greater improvement with respect to cardiometabolic risk factors and a greater increase in participant-reported physical functioning from baseline than those who received placebo. Nausea and diarrhea were the most common adverse events with semaglutide; they were typically transient and mild-to-moderate in severity and subsided with time. More participants in the semaglutide group than in the placebo group discontinued treatment owing to gastrointestinal events (59 [4.5%] vs. 5 [0.8%]).In participants with overweight or obesity, 2.4 mg of semaglutide once weekly plus lifestyle intervention was associated with sustained, clinically relevant reduction in body weight. (Funded by Novo Nordisk; STEP 1 ClinicalTrials.gov number, NCT03548935).
- Subjects :
- Adult
Diarrhea
Male
Pediatrics
medicine.medical_specialty
Injections, Subcutaneous
Glucagon-Like Peptides
Once weekly
030204 cardiovascular system & hematology
Overweight
Body Mass Index
law.invention
Prediabetic State
03 medical and health sciences
0302 clinical medicine
Double-Blind Method
Randomized controlled trial
Cholelithiasis
Glucagon-Like Peptide 1
law
Weight loss
Weight Loss
Global health
Humans
Medicine
Healthy Lifestyle
Obesity
030212 general & internal medicine
business.industry
Semaglutide
food and beverages
Nausea
General Medicine
Middle Aged
medicine.disease
Lipids
Body Composition
Female
Human medicine
Anti-Obesity Agents
medicine.symptom
business
Body mass index
Subjects
Details
- ISSN :
- 15334406 and 00284793
- Volume :
- 384
- Database :
- OpenAIRE
- Journal :
- New England Journal of Medicine
- Accession number :
- edsair.doi.dedup.....87fd38f53a058d926dc8c22a4bf5fe5e