Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial
Authors' conclusion
In adults with overweight or obesity without type 2 diabetes, oral semaglutide 50 mg once per day led to a superior and clinically meaningful decrease in bodyweight compared with placebo.
Study context
- Population
- Adults with BMI ≥30 kg/m², or ≥27 kg/m² with bodyweight-related complications and comorbidities, without T2D; 50 outpatient clinics in Asia, Europe and North Americarandomised 1:1
- Participants
- 667 adults
- Comparison
- Oral semaglutide 50 mg once daily vs placebo, plus lifestyle intervention, for 68 weeks
- Oral semaglutide 50 mgn = 334
- Placebon = 333reference
- Primary endpoint
- Coprimary: percentage change in bodyweight and bodyweight reduction ≥5%
- Follow-up
- Week 68
Methodological detailsdouble-blind, placebo-controlled, phase 3, superiority, multicentre (50 outpatient clinics, nine countries)
- Double-blind
- Placebo-controlled
- Phase 3
- Superiority
- Multicentre (50 outpatient clinics, nine countries)
Primary result
As reported in the abstract
Bodyweight change and bodyweight reduction ≥5%
Oral semaglutide 50 mg
−15.1
mean · SE 0.5 · %
Placebo
−2.4
mean · SE 0.5 · %
Oral semaglutide 50 mg vs PlaceboEstimated treatment difference, percentage points (95% CI)P value
Bodyweight change
−12.7(−14.2 to −11.3)
P < 0.0001Oral semaglutide 50 mg vs PlaceboOdds ratio (95% CI)P value
Bodyweight reduction ≥5%
12.6(8.5–18.7)
P < 0.0001Further findings
| Outcome | Oral semaglutide 50 mg | Placebo | OR (CI) | |
|---|---|---|---|---|
| Bodyweight reduction ≥10% · week 68 | 69% | 12% | 14.7 (9.6–22.6) | |
| Bodyweight reduction ≥15% · week 68 | 54% | 6% | 17.9 (10.4–30.7) | |
| Bodyweight reduction ≥20% · week 68 | 34% | 3% | 18.5 (8.8–38.9) | |
| 0.050.21520Odds ratio (log scale) |
Safety
Adverse events
Gastrointestinal adverse events (mostly mild to moderate)
- Adverse events: participants who received ≥1 dose
Original publication
Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. Published 26 June 2023. doi:10.
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