Once-Weekly Semaglutide in Adults with Overweight or Obesity (STEP 1 Trial)
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
New England Journal of Medicine · Vol. 384(11) · pp. 989–1002 · 2021
Landmark Phase 3 RCT (STEP 1) demonstrating that once-weekly semaglutide 2.4 mg produces unprecedented 14.9% mean body weight reduction over 68 weeks in adults with obesity. Establishes GLP-1 receptor agonists as the most effective pharmacological weight loss intervention to date.
Key Findings
Mean body weight reduction of 14.9% with semaglutide vs. 2.4% with placebo at 68 weeks
86.4% of participants achieved ≥5% weight loss; 69.1% achieved ≥10%
Significant improvements in cardiometabolic risk factors (BP, lipids, HbA1c)
Improved physical functioning and quality of life scores
Most common adverse effects: nausea, vomiting, diarrhea (generally transient)
Methodology
Phase 3 double-blind RCT across 16 countries. 1961 participants with BMI ≥30 or ≥27 with comorbidities. 68-week treatment with lifestyle intervention in both arms.
Limitations
Weight regain observed after discontinuation. Long-term cardiovascular outcomes data still accumulating. Cost and access barriers significant.
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