Efficacy and safety of monlunabant in adults with obesity and metabolic syndrome: a double-blind, randomised, placebo-controlled, phase 2a trial
Authors' conclusion
Participants receiving monlunabant showed statistically significant and clinically meaningful weight loss compared with those receiving placebo for all tested doses. Only slightly greater weight loss was observed at higher doses, whereas adverse events appeared dose dependent. Further investigation is needed to assess the safety and efficacy of lower doses of monlunabant, to evaluate its potential as a medication for obesity.
Study context
- Population
- Adults with obesity and metabolic syndrome183 completed
- Participants
- 243 adults
- Comparison
- Once-daily oral monlunabant 10 mg, 20 mg or 50 mg vs placebo
- Monlunabant 10 mgn = 61
- Monlunabant 20 mgn = 61
- Monlunabant 50 mgn = 60
- Placebon = 61reference
- Primary endpoint
- Mean bodyweight (kg) change from baseline vs placebo
- Follow-up
- Week 16
Methodological detailsdouble-blind, placebo-controlled, dose-ranging, phase 2a, 25 outpatient research centres in Canada
- Double-blind
- Placebo-controlled
- Dose-ranging
- Phase 2a
- 25 outpatient research centres in Canada
Primary result
As reported in the abstract
Bodyweight change from baseline
Each group vs placeboLeast squares mean difference, kg (95% CI)
Monlunabant 10 mg
−6.4(−8.0 to −4.9)
Monlunabant 20 mg
−6.9(−8.5 to −5.3)
Monlunabant 50 mg
−8.0(−9.7 to −6.4)
Further findings
- No deaths were reported
Safety
Adverse events (mostly mild to moderate GI and psychiatric disorders)
| Outcome | Monlunabant 10 mg | Monlunabant 20 mg | Monlunabant 50 mg | Placebo |
|---|---|---|---|---|
| Withdrawals due to adverse events | 13% | 27% | 42% | 0 events |
Withdrawals due to adverse events
- Withdrawals appeared dose-dependent, driven by nausea, anxiety, diarrhoea, irritability and sleep disorder
Original publication
Efficacy and safety of monlunabant in adults with obesity and metabolic syndrome: a double-blind, randomised, placebo-controlled, phase 2a trial. Lancet Diabetes Endocrinol. Published 29 September 2025. doi:10.
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