Aleniglipron Achieves Over 16% Weight Loss at 44 Weeks in Phase 2 Trial
Aleniglipron delivered placebo-adjusted mean weight loss of 16.3% at 180 mg and 16.0% at 240 mg after 44 weeks in the Phase 2 ACCESS II trial, with no plateau observed. Open-label extension data showed up to 16.2% weight loss by week 56 at 120 mg and low discontinuation rates (2–3.7%).
1. Phase 2 ACCESS II Efficacy Data
Aleniglipron achieved placebo-adjusted mean weight losses of 16.3% (39 lbs) at 180 mg and 16.0% (37 lbs) at 240 mg after 44 weeks, both with p<0.0001, and showed no evidence of a weight loss plateau in 85 adults living with obesity.
2. Open-Label Extension and Safety Profile
In the ACCESS OLE study, 120 mg of aleniglipron delivered continued weight loss up to 16.2% (40.5 lbs) by week 56, with adverse event-related discontinuation rates of 2.0% in the OLE and 3.4% in a body composition study, and just 3.7% in ACCESS II at doses ≥120 mg.
3. Regulatory Pathway and Next Steps
The company has scheduled an End-of-Phase 2 meeting with the FDA in Q2 2026 and plans to initiate Phase 3 development in the second half of 2026, with a conference call held to discuss the full ACCESS program results.