Semaglutide
STEP 1: Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity (NEJM 2021)
Evidence under physician review
Approved indication wording and source pending sign-off.
- Study
- STEP 1: Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity (NEJM 2021) · NCT03548935
- Population
- Adults 18 years or older with BMI ≥30 kg/m², or BMI ≥27 kg/m² plus at least one weight-related comorbidity (hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease), and a history of at least one unsuccessful dietary effort to lose weight. Excluded HbA1c ≥48 mmol/mol (6.5%) — i.e. diabetes — and a self-reported weight change over 5 kg within 90 days of screening. Randomized 2:1 to semaglutide 2.4 mg (1306) or placebo (655); 129 sites in 16 countries.
- Dose
- Once-weekly subcutaneous semaglutide 2.4 mg (escalated from 0.25 mg through 0.5, 1.0 and 1.7 mg at 4-week intervals, maintenance dose reached at week 16) versus matching placebo, each as an adjunct to a reduced-calorie diet and increased physical activity.
- Citation
- Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021;384(11):989-1002. doi:10.1056/NEJMoa2032183. Epub 2021 Feb 10. PMID: 33567185.