Highlights
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Goals
To explore changes in body weight and cardiometabolic risk factors after treatment discontinuation in the STEP 1 extension trial.
Materials and methods
STEP 1 (NCT03548935) randomized 1961 adults with body mass index ≥30 kg/m 2 (or ≥ 27 kg/m 2 with ≥1 weight-related comorbidity) without diabetes to 2.4 mg subcutaneous semaglutide once per week for 68 weeks (including 16-week dose escalation) or placebo, as an adjunct to lifestyle intervention.
At week 68, treatments (including lifestyle intervention) were stopped.
A no-treatment extension evaluated a representative subset of participants who had completed the 68-week treatment for an additional year. This subset comprised all eligible participants from any site in Canada, Germany, and the United Kingdom, and sites in the United States and Japan with the largest recruitment in the main phase. All analyzes in the extension were exploratory.
Results
Extension analyzes included 327 participants. From weeks 0 to 68, mean weight loss was 17.3% (SD: 9.3) with semaglutide and 2.0% (6.1) with placebo.
Following treatment discontinuation, semaglutide and placebo participants regained 11.6 (7.7) and 1.9 (4.8) percentage points of lost weight, respectively, at week 120, resulting in net losses of 5.6% (8.9) and 0.1% (5.8), respectively, from week 0-120.
Cardiometabolic improvements observed from weeks 0 to 68 with semaglutide reverted to baseline at week 120 for most parameters.
Conclusions
One year after withdrawal of once-weekly subcutaneous semaglutide 2.4 mg and lifestyle intervention, participants regained two-thirds of their previous weight loss, with similar changes in cardiometabolic parameters.
The findings confirm the chronicity of obesity and suggest that ongoing treatment is required to maintain improvements in weight and health.
