Clinical research
OASIS 4: Oral semaglutide 25 mg for weight management
Phase 3, randomised, double-blind, placebo-controlled. 307 randomised 2:1 (205 active, 102 placebo), over 64 weeks of treatment plus a 7-week off-treatment follow-up. Sponsor: Novo Nordisk.
OASIS 4 (NCT05564117) tested oral semaglutide 25 mg once daily, with a 12-week dose escalation at 25 mg once daily against placebo in 307 adults with obesity (bmi 30 or above) or overweight (bmi 27–29.9) with at least one weight-related comorbidity, excluding people with diabetes. mean baseline weight 106 kg, mean bmi 38.13.6% mean weight reduction on the treatment-policy estimand versus 2.2% placebo; 16.6% versus 2.7% among those who remained on treatment. One in three adherent participants achieved 20% or greater reduction Primary source linked: the source is a citable peer-reviewed / registry record, which we have not independently re-extracted from the full paper in this session.
Study design
| Design | Phase 3, randomised, double-blind, placebo-controlled |
|---|---|
| Population | 307 adults with obesity (BMI 30 or above) or overweight (BMI 27–29.9) with at least one weight-related comorbidity, excluding people with diabetes. Mean baseline weight 106 kg, mean BMI 38 |
| Sample size | 307 randomised 2:1 (205 active, 102 placebo) |
| Intervention | Oral semaglutide 25 mg once daily, with a 12-week dose escalation (25 mg once daily) |
| Comparator | Placebo |
| Duration | 64 weeks of treatment plus a 7-week off-treatment follow-up |
| Primary endpoint | Co-primary: percentage change in body weight and the proportion achieving at least 5% reduction at week 64 |
| Sponsor | Novo Nordisk |
Results
13.6% mean weight reduction on the treatment-policy estimand versus 2.2% placebo; 16.6% versus 2.7% among those who remained on treatment. One in three adherent participants achieved 20% or greater reduction
| Arm | Reported change |
|---|---|
| Oral semaglutide, treatment-policy | 13.6% |
| Oral semaglutide, adherent | 16.6% |
| Placebo | 2.2% |
Adverse events & discontinuations
Serious adverse events occurred less frequently with oral semaglutide than with placebo, 3.9% against 8.8%
Limitations
Industry-funded. Small by the standards of this field at 307 participants, against 2,539 in SURMOUNT-1. Excludes people with diabetes. Two estimands are published and differ by three percentage points. The 7-week off-treatment period is too short to establish durability.
Practical interpretation
This is one trial, reported by Novo Nordisk, read directly against the registry and publication linked below — GLP Ranked has not re-run the statistics or obtained the patient-level data. Results describe group averages under trial conditions and may not describe any individual's outcome, including with a compounded, non-FDA-approved version of a similar active ingredient. Always check the primary source before citing a specific number.
Sources
- Wharton S, Lingvay I, Bogdanski P, et al. N Engl J Med 2025;393(11):1077-1087 — Peer-reviewed publication
- OASIS 4 — ClinicalTrials.gov record NCT05564117 — Trial registry record
Cite this page
GLP Ranked. "OASIS 4: Oral semaglutide 25 mg for weight management." Updated 2026-07-24. https://glpranked.com/research/oasis-4/
GLP Ranked. "OASIS 4: Oral semaglutide 25 mg for weight management." Updated 2026-07-24. https://glpranked.com/research/oasis-4/