Phase 2b and ACCESS II studies show up to 15.3% weight reduction with promising tolerability, positioning aleniglipron as a potential best-in-class oral therapy for obesity.
Structure Therapeutics (GPCR) has announced highly encouraging topline results from its multi-study ACCESS clinical program evaluating aleniglipron, an investigational once-daily oral GLP-1 receptor agonist designed to treat obesity and overweight patients with weight-related comorbidities. The data released include 36-week results from the Phase 2b ACCESS core study, the exploratory ACCESS II study evaluating higher doses, interim insights from a Body Composition study, and early findings from an ongoing open-label extension (OLE).
Across both controlled studies, aleniglipron demonstrated robust, clinically meaningful, and dose-dependent weight loss with a tolerability profile consistent with existing GLP-1 therapies, making it one of the most promising oral candidates under development.
Phase 2b ACCESS: Up to 12.1% Mean Weight Loss
The randomized, double-blind Phase 2b trial enrolled 230 adults living with obesity (BMI ≥ 30) or overweight with comorbidities (BMI ≥ 27). After 36 weeks, aleniglipron achieved:
- 11.3% placebo-adjusted weight loss at 120 mg (27.3 lbs; p<0.0001)
- Mean weight loss of 12.1% in the 120 mg arm
- 86% of patients achieving ≥5% weight loss
- 70% achieving ≥10% weight loss
Patients also saw clinically meaningful improvements in systolic blood pressure and HbA1c. Treatment discontinuations related to adverse events averaged 10.4%, consistent with the GLP-1 class.
ACCESS II: Higher Doses Deliver Up to 15.3% Weight Loss
ACCESS II evaluated doses up to 240 mg across 85 participants. At 36 weeks:
- Placebo-adjusted reductions reached 15.3% at 240 mg (35.5 lbs; p<0.0001)
- All doses achieved statistical significance
- Weight loss showed no signs of plateauing, suggesting continued benefit beyond 36 weeks.
Improved Tolerability with Lower Starting Dose
A separate Body Composition study using a 2.5 mg starting dose showed significantly better tolerability in early titration, with no treatment discontinuations through the 5 mg phase. This supports a refined dosing schedule for Phase 3.
Open-Label Extension: Continued Weight Loss at 44 Weeks
Preliminary OLE results show sustained weight loss beyond Week 36, further underscoring aleniglipron’s potential durability.
A Potential Oral Backbone Therapy for Obesity
CEO Dr. Raymond Stevens said the data demonstrate “competitive, dose-dependent weight loss with no plateau,” positioning aleniglipron as a scalable oral therapy that could meaningfully expand access to GLP-1 treatments.
With obesity affecting more than 650 million people globally, experts believe aleniglipron could become a transformative option—if Phase 3 results align with this promising early profile.
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