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This double-blind trial randomized 1961 individuals with overweight or obesity in a 2:1 ratio to 68 weeks of once-weekly 2.4 mg subcutaneous semaglutide versus placebo plus lifestyle intervention. The semaglutide group had a mean change in body weight of −14.9% from baseline compared with −2.4% in the placebo group. Participants achieving weight reductions of 5% or more, 10% or more, and 15% or more were significantly higher in the semaglutide group. Cardiometabolic risk factors also were improved to a greater extent in the semaglutide group.
Semaglutide 2.4 mg weekly in individuals who are overweight or obese, in addition to lifestyle intervention, led to significant, clinically relevant weight reduction.
– Ana Perdigoto, MD, PhD
This abstract is available on the publisher's site.
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; P<0.001). 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 (P<0.001 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).
Once-Weekly Semaglutide in Adults with Overweight or Obesity
N. Engl. J. Med 2021 Feb 10;[EPub Ahead of Print], JPH Wilding, RL Batterham, S Calanna, M Davies, LF Van Gaal, I Lingvay, BM McGowan, J Rosenstock, MTD Tran, TA Wadden, S Wharton, K Yokote, N Zeuthen, RF Kushner