STEP 1

Once-Weekly Semaglutide in Adults with Overweight or Obesity

Patient / Population Intervention / Exposure Comparison Outcome

In 1,961 adults with overweight or obesity without type 2 diabetes, subcutaneous semaglutide 2.4 mg weekly reduced body weight at 68 weeks compared with placebo.

1,961

Design

Double-blind RCT, 68 weeks

Endpoint

Percent change in body weight

Relevance

ResultWeight loss −14.9 % vs −2.4 % (difference −12.4 pp; p<0.001); ≥15 % loss in 50 % of the semaglutide group.

Wilding JPH, et al. N Engl J Med. 2021;384(11):989-1002. 10.1056/NEJMoa2032183

Discussion & critique

Basis of the Wegovy approval — STEP 4 later showed weight regain on withdrawal, framing obesity as a chronic disease requiring continuous therapy.