Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity
Primary result · Mean % change in body weight from baselineResult — go to the resultEstimated difference −11.4 percentage points 95% CI −13.9 to −9.0Authors' conclusion
Oral semaglutide at a dose of 25 mg once daily resulted in a greater mean reduction in body weight than placebo in participants with overweight or obesity.
Study context
- Population
- Adults without diabetes with body-mass index (BMI) ≥30, or BMI ≥27 with ≥1 obesity-related complicationrandomized 2:1
- Participants
- 205 vs 102
- Comparison
- Oral semaglutide 25 mg once daily vs placebo, plus lifestyle interventions
- Oral semaglutiden = 205
- Placebon = 102reference
- Primary endpoint
- Coprimary: % change in body weight and body-weight reduction ≥5%
- Follow-up
- Week 64
Methodological detailsdouble-blind, placebo-controlled, multicentre (22 sites in four countries), 71-week trial
- Double-blind
- Placebo-controlled
- Multicentre (22 sites in four countries)
- 71-week trial
Primary result
Mean % change in body weight from baseline
Estimated difference
−11.4 percentage points
95% CI −13.9 to −9.0
P < 0.001
Change by group
Oral semaglutide
−13.6
estimated mean · %
Placebo
−2.2
estimated mean · %
Oral semaglutidevs Placebo
estimated difference −11.4 percentage points (95% CI −13.9 to −9.0); P < 0.001
As reported in the abstract
- Body-weight reduction ≥5% significantly more likely with oral semaglutide vs placebo
- P < 0.001
Secondary outcomes
Body-weight reductions ≥10%, ≥15% and ≥20%
- Significantly more likely with oral semaglutide vs placebo
- P < 0.001 for all comparisons
Improved IWQOL-Lite-CT Physical Function score
- Significantly more likely with oral semaglutide vs placebo
- P < 0.001
Safety
Gastrointestinal adverse events
Original publication
Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity. N Engl J Med. Published 18 September 2025. doi:10.
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