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The New England Journal of Medicine ORIGINAL ARTICLE
Once-Weekly Semaglutide in Adults with Overweight or Obesity (STEP 1)
Wilding JPH, et al.
Study Snapshot
Study drug: Semaglutide 2.4 mg once weekly Drug
Treatment duration: 68 weeks with lifestyle support Duration
Primary objective: change in body weight at week 68 Objective
The New England Journal of Medicine POPULATION AND RANDOMIZATION
Participant Design
Population: Adults with BMI >=30, or >=27 with one weight-related condition Population
Sample size: 1,961 participants Sample
Randomization: 2:1 semaglutide vs placebo Design
The New England Journal of Medicine OUTCOME DEFINITION
Endpoints
Endpoint 1: Percent change in body weight at week 68 Endpoint 1
Endpoint 2: Share of participants with >=5% weight loss Endpoint 2
Secondary endpoint: Change in waist circumference Secondary
The New England Journal of Medicine PRIMARY RESULTS
Efficacy Results
Mean weight change: -14.9% semaglutide vs -2.4% placebo Main Result
Participants achieving >=5% weight loss: 86% vs 32% Response
Results assessed at week 68 Timing
The New England Journal of Medicine ADVERSE EVENTS
Safety Profile
Common side effects: nausea, diarrhea, vomiting, constipation Common AEs
Stopped due to side effects: 7.0% semaglutide vs 3.1% placebo Discontinuation
Serious adverse events: similar between groups Serious AEs
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