STEP-1 established the modern GLP-1 era for weight management. Semaglutide at the 2.4-milligram weekly dose (marketed as Wegovy) achieved 14.9 percent mean body-weight loss at 68 weeks in 1,961 adults with obesity. The Phase 3 randomized controlled trial was published in the New England Journal of Medicine in March 2021 (Wilding JPH et al, NEJM 2021;384:989-1002). Follow-on SELECT trial added cardiovascular benefit, leading to FDA approval for cardiovascular risk reduction.
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That's −17.8 kg — you'd weigh .
Based on the 20.9% trial-mean. Individual outcomes vary.STEP-1 is the pivotal phase-3 trial of semaglutide 2.4 mg for chronic weight management. Its results led directly to the FDA approval of Wegovy in 2021.
Adults with overweight or obesity, without type 2 diabetes — isolating the weight-loss effect of semaglutide 2.4 mg from any glycemic confounder.
Weekly subcutaneous semaglutide, escalated every 4 weeks to minimise GI side-effects. The same titration ladder is used in clinical practice today.
Semaglutide 2.4 mg produced a six-fold greater mean weight loss versus placebo over 68 weeks — the largest single-agent phase-3 weight-loss effect reported at the time of publication.
Safety in STEP-1 mirrored the established GLP-1 class profile — transient gastrointestinal events dominating the first months and resolving as patients reached maintenance dose.
Three implications still shape how semaglutide 2.4 mg is prescribed today — including in TRT Bangkok's Wegovy program.
14.9% mean weight loss was the largest phase-3 single-agent obesity-trial result published at the time — the benchmark that subsequent trials had to beat.
STEP-1 led directly to the June 2021 FDA approval of Wegovy (semaglutide 2.4 mg) for chronic weight management in adults with obesity or overweight + comorbidity.
STEP-1 became the reference comparator for every subsequent weight-loss trial — including the head-to-head SURMOUNT-5 study of tirzepatide vs semaglutide.
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STEP-1 reference: Wilding JPH, Batterham RL, Calanna S, et al. Once-weekly semaglutide in adults with overweight or obesity. N Engl J Med. 2021;384(11):989-1002. STEP-2 through STEP-5 expanded results: STEP-2 (T2D patients, -9.6 percent), STEP-3 (intensive behavioral therapy, -16.0 percent), STEP-4 (maintenance, additional 7.9 percent loss with continuation), STEP-5 (104-week, -15.2 percent sustained). SELECT (NEJM 2023) showed 20 percent reduction in major adverse cardiovascular events over 5 years.
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STEP-1 (Semaglutide Treatment Effect in People with obesity) is a Phase 3 randomized controlled trial of weekly semaglutide 2.4 mg (Wegovy) for chronic weight management. Published in NEJM March 2021 (Wilding JPH et al, NEJM 2021;384:989-1002).
1,961 adults with obesity (BMI ≥ 30) or overweight (BMI ≥ 27) plus one weight-related condition, EXCLUDING type 2 diabetes. Mean baseline weight 105.3 kg, mean BMI 37.9. 74.1% female. Most had at least one comorbidity.
Semaglutide 2.4 mg weekly subcutaneous injection vs placebo. Dose escalation over 16 weeks (0.25 → 0.5 → 1.0 → 1.7 → 2.4 mg). All participants received lifestyle counseling. Treatment duration: 68 weeks.
Mean percent change in body weight at week 68: −14.9% with semaglutide vs −2.4% with placebo. Difference: −12.4 percentage points (95% CI −13.4 to −11.5, P<0.001). 86.4% of semaglutide patients achieved ≥5% weight loss; 50.5% achieved ≥15%.
Most common: nausea (44.2%), diarrhea (31.5%), vomiting (24.8%), constipation (23.4%). Most mild-to-moderate, occurring during titration. Discontinuation due to adverse events: 7.0% (semaglutide) vs 3.1% (placebo). Gallbladder disorders: 2.6% vs 1.2%.
The SELECT trial (2023, NEJM) followed STEP-1 — randomized 17,604 patients with obesity and pre-existing cardiovascular disease (no diabetes) to semaglutide 2.4 mg vs placebo for ~5 years. Result: 20% reduction in major adverse cardiovascular events. Wegovy now FDA-approved for CV risk reduction.
Yes. STEP-2 (T2D patients): −9.6% weight loss. STEP-3 (intensive behavioral therapy): −16.0%. STEP-4 (maintenance): patients who continued semaglutide lost additional 7.9%; those who switched to placebo regained 6.9%. STEP-5 (2-year): −15.2% sustained at 104 weeks.
SURMOUNT-1 (tirzepatide 15 mg, 72 weeks): −20.9% weight loss. STEP-1 (semaglutide 2.4 mg, 68 weeks): −14.9%. Tirzepatide produced ~40% greater weight loss. The SURMOUNT-5 head-to-head trial (2025) confirmed tirzepatide's superiority in direct comparison.
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See clinic →The STEP-1 trial (Wilding et al., New England Journal of Medicine 2021) enrolled 1,961 adults with overweight or obesity over 68 weeks at 129 international sites. Participants receiving semaglutide 2.4mg subcutaneously weekly achieved a mean weight reduction of 14.9 percent versus 2.4 percent with placebo. 86.4 percent of semaglutide participants achieved 5 percent or greater weight loss versus 31.5 percent in the placebo arm, with 50.5 percent achieving 15 percent or more weight loss. The trial established semaglutide as the first GLP-1 receptor agonist to demonstrate weight loss approaching bariatric surgery thresholds.
Last reviewed by Dr. Kenika Tonkam, Medical Director, TRT Bangkok · June 3, 2026
