1. Aleniglipron achieved 11.3% and 15.3% weight loss in Phase 2b studies. 2. No adverse events led to treatment discontinuations at the lower 2.5 mg dose. 3. Plans for Phase 3 clinical trials slated for mid-2026 are underway. 4. Aleniglipron shows potential as best-in-class oral therapy for obesity. 5. Structure Therapeutics emphasizes accessibility and scalability of treatment options.
FAQ
Why Bullish?
Strong weight loss results and no severe side effects support positive market reception similar to prior obesity treatment launches like Saxenda.
How important is it?
New data in obesity treatments aligns with growing market demand, increasing investor interest in GPCR.
Why Long Term?
Phase 3 development expected to start mid-2026 suggests significant future growth for GPCR.
Structure Therapeutics Reports Positive Topline Data from ACCESS Program for Aleniglipron (NASDAQ: GPCR)
On December 8, 2025, Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage biopharmaceutical company focused on innovative treatments for metabolic diseases, announced promising topline data from its ACCESS clinical program for aleniglipron. This investigational oral small molecule is aimed at treating individuals with obesity and related weight-related co-morbidities. The study results demonstrate a significant weight loss potential for aleniglipron, paving the way for its advancement into Phase 3 clinical development anticipated in mid-2026.
Key Findings from the Phase 2b ACCESS Study
The Phase 2b ACCESS study revealed a placebo-adjusted mean weight loss of 11.3% (27.3 lbs) with the 120 mg dose after 36 weeks of treatment. Notably, the study also reported a 10.4% adverse event (AE)-related treatment discontinuation rate. In the ongoing exploratory ACCESS II study, participants receiving the 240 mg dose experienced an impressive placebo-adjusted mean weight loss of 15.3% (35.5 lbs), further supporting the efficacy of aleniglipron.
- Mean Weight Loss (120 mg): 11.3% (27.3 lbs)
- Mean Weight Loss (240 mg): 15.3% (35.5 lbs)
- Discontinuation Rate: 10.4%
Clinical Implications of the ACCESS Studies
Raymond Stevens, Ph.D., CEO of Structure Therapeutics, emphasized the significance of the results, stating, “Aleniglipron is differentiated and delivers clinically meaningful, competitive, and dose-dependent weight loss with a safety profile appropriate for chronic use in a disease affecting millions.” These findings indicate that aleniglipron could serve as a cornerstone therapy for obesity, being both accessible and scalable.
Dr. Julio Rosenstock, Chair of the ACCESS program Steering Committee, noted the absence of a weight loss plateau by Week 36, calling the results encouraging. He emphasized the potential of non-peptide small molecule GLP-1 receptor agonists like aleniglipron to transform obesity treatment and enhance patient access.
Details of the Phase 2b ACCESS Study
The core Phase 2b ACCESS study examined 230 adult participants with obesity or overweight and included a randomized, double-blind, placebo-controlled design. Participants underwent a 4-week titration period commencing at 5 mg of aleniglipron, reaching target doses of 45 mg, 90 mg, or 120 mg daily. All active arms achieved statistical significance regarding primary and key secondary endpoints.
| Dose | Mean % Change in Body Weight at 36 Weeks | Placebo-Adjusted Mean % Change | P-value |
|---|---|---|---|
| Aleniglipron 45 mg | -9.0% | -8.2% | p<0.0001 |
| Aleniglipron 90 mg | -10.7% | -9.8% | p<0.0001 |
| Aleniglipron 120 mg | -12.1% | -11.3% | p<0.0001 |
| Placebo | -0.8% | N/A | N/A |
Further analysis indicated that 86% of participants on the 120 mg dose achieved a minimum of 5% weight loss, while 70% reached 10% weight loss. Additionally, clinically relevant improvements in systolic blood pressure and HbA1c levels were observed.
Current Studies and Future Directions
The exploratory ACCESS II study, involving 85 adults, is assessing the efficacy of two higher doses of aleniglipron (120 mg, 180 mg, and 240 mg), with results consistent across weight loss measurements compared to placebo. The Body Composition Study, which initiates with a lower 2.5 mg starting dose, aims to evaluate aleniglipron’s effect on body fat loss.
“Obesity remains a complex, chronic disease,” stated Joe Nadglowski, President and CEO of the Obesity Action Coalition. “Aleniglipron’s results signify a crucial advancement in accessible treatment options for individuals struggling with obesity.”