Structure Therapeutics’ oral GLP‑1 aleniglipron achieved up to 16.2% weight loss in the Phase 2b ACCESS trial, with durable efficacy, favorable safety, and Phase 3 initiation planned for Q3 2026.
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
Structure Therapeutics has reported detailed Phase 2b ACCESS trial results for aleniglipron, its investigational once-daily oral GLP-1 receptor agonist, in Nature Medicine. The data were also presented at the American Diabetes Association (ADA) 86th Scientific Sessions, highlighting the therapy’s potential as an oral treatment option for chronic weight management.
Statistically Significant Weight Loss and Cardiometabolic Benefits
The randomized, double-blind, placebo-controlled Phase 2b ACCESS trial (NCT06693843) met its primary endpoint, with all three maintenance-dose groups achieving statistically significant weight reductions versus placebo over 36 weeks. Key secondary endpoints were also met, including improvements in systolic and diastolic blood pressure, waist circumference, high-sensitivity C-reactive protein (hsCRP), and HbA1c, suggesting broader cardiometabolic benefits beyond weight reduction.
Durability Beyond 36 Weeks
A predefined interim analysis from the ongoing open-label extension study showed continued weight loss beyond the double-blind treatment period, with no apparent plateau after a median of approximately 20 additional weeks of follow-up. Participants who transitioned from the 45 mg, 90 mg, and 120 mg treatment arms achieved weight reductions of 13.3%, 16.2%, and 15.3%, respectively.
The findings suggest weight loss may continue beyond 36 weeks of treatment, supporting the durability of aleniglipron’s effect and providing additional evidence for long-term obesity management.
Manageable Safety Profile
Safety findings were consistent with the established GLP-1 drug class profile. Gastrointestinal adverse events, primarily nausea and vomiting, were generally mild to moderate and decreased over time. Overall discontinuation due to treatment-related adverse events remained low at 10.4%, with most occurring during the initial dose-escalation period.
Investigators also reported that participants who temporarily interrupted treatment were often able to restart therapy or resume dose escalation without a substantial increase in vomiting events, supporting a manageable tolerability profile during long-term treatment.
Competitive Positioning in Oral GLP-1 Development
Aleniglipron enters an increasingly competitive oral obesity market that includes several investigational GLP-1 receptor agonists. The continued weight loss observed in the extension study and the low discontinuation rate may support its positioning as development advances.
Regulatory Pathway and Pipeline Expansion
Structure Therapeutics plans to initiate Phase 3 development in the third quarter of 2026 following discussions with the U.S. Food and Drug Administration. The program is expected to use a 2.5 mg starting dose and evaluate multiple maintenance-dose regimens based on findings from the ACCESS study.
The company also plans to present additional obesity pipeline data during ADA 2026, including programs involving amylin-based therapies and combination approaches intended to enhance weight-loss efficacy through complementary biological pathways.
Path Forward
Julio Rosenstock, MD, Chair of the aleniglipron Steering Committee, highlighted the continued weight loss observed beyond the core treatment period and the potential clinical value of a once-daily oral GLP-1 therapy.
If Phase 3 studies confirm the efficacy, durability, and tolerability observed in ACCESS, aleniglipron could emerge as a competitive oral GLP-1 option for long-term obesity management.
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About the Writer
Chikkula Pavan Kumar (LinkedIn), PharmD is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.