Oral small molecule GLP-1 receptor agonist aleniglipron in people with overweight or obesity: a randomized, double-blind, placebo-controlled phase 2b trial
An erratum to this article was published (Nat Med, Aug 2026 ↗)
Authors' conclusion
Clinically relevant weight reductions of up to 11.3% with a tolerability profile consistent with the GLP-1RA class support further development of aleniglipron for obesity treatment.
Study context
- Population
- Adults with obesity or overweight (mean BMI 39.5 kg m-2, 54% female)
- Participants
- 230 adults
- Comparison
- Once-daily oral aleniglipron 45, 90 or 120 mg vs placebo
- Primary endpoint
- Placebo-adjusted LS mean body-weight change from baseline
- Follow-up
- Week 36
Methodological detailsdouble-blind, placebo-controlled, phase 2b
- Double-blind
- Placebo-controlled
- Phase 2b
Primary result
As reported in the abstract
Placebo-adjusted LS mean
−8.2 %
95% CI −11.1 to −5.3%P < 0.0001
Aleniglipron 45 mg
Placebo-adjusted LS mean
−9.8 %
95% CI −12.5 to −7.2%P < 0.0001
Aleniglipron 90 mg
Placebo-adjusted LS mean
−11.3 %
95% CI −13.9 to −8.6%P < 0.0001
Aleniglipron 120 mg
Further findings
Weight loss in ongoing open-label extension · median treatment duration of 20 weeks
- Continued weight loss was observed
- Interim analysis
Safety
Gastrointestinal events, discontinuations and liver injury
- Treatment-related discontinuations across aleniglipron arms
- 10.4%
- Events of drug-induced liver injury
- 0
- GI events generally mild to moderate, decreased in frequency over time; little to no recurrence of vomiting after reintroduction following permitted dose interruptions
Original publication
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