Semaglutide versus placebo in individuals with poor weight loss after bariatric surgery: a double-blinded, randomized, placebo-controlled trial
Primary result · Change in % body weight from baselineResult — go to the resultMean adjusted treatment difference −19.18 % 95% CI −23.4 to −14.8Authors' conclusion
BARI-STEP demonstrates that in people with a suboptimal clinical response after MBS, semaglutide results in substantial and clinically significant body weight reduction along with improvement in metabolic parameters and quality of life, compared to placebo.
Study context
- Population
- Adults ≥1 year after gastric bypass or SG with suboptimal clinical response (<20% weight loss from surgery); mean (SD) age 47.3 (10.3) years, 82.9% female63 in ITT sample
- Participants
- 70 adults
- Comparison
- Semaglutide 2.4 mg weekly vs placebo, adjunct to lifestyle intervention
- Semaglutide 2.4 mgn = 35
- Placebon = 35reference
- Primary endpoint
- Percentage weight loss, ITT analysis
- Follow-up
- 68 weeks
Methodological detailsdouble-blinded, placebo-controlled, randomized (1:1)
- Double-blinded
- Placebo-controlled
- Randomized (1:1)
Primary result
Change in % body weight from baseline · week 68
Mean adjusted treatment difference
−19.18 %
95% CI −23.4 to −14.8
P < 0.001
Change by group
Semaglutide 2.4 mg
−18.0
mean · SD 9.2 · %
Placebo
+0.4
mean · SD 7.0 · %
Semaglutide 2.4 mgvs Placebo
mean adjusted treatment difference −19.18 % (95% CI −23.4 to −14.8); P < 0.001
As reported in the abstract
Safety
Adverse events
- Serious adverse events (AEs)
- 8
- Suspected unexpected serious adverse reaction
- 1
- Treatment-related deaths
- 0
- AEs consistent with known safety and tolerability profile of semaglutide; no new safety concerns
Original publication
Semaglutide versus placebo in individuals with poor weight loss after bariatric surgery: a double-blinded, randomized, placebo-controlled trial. Nat Med. Published 22 May 2026. doi:10.
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