Structure Therapeutics Announces Positive Topline Results for Oral GLP-1 Agonist Aleniglipron from ACCESS Program

Structure Therapeutics Demonstrates Promising Weight Loss Data with Oral GLP-1 Agonist Aleniglipron

Structure Therapeutics Inc. announced positive topline data from its ACCESS clinical program evaluating aleniglipron, an investigational once-daily oral small molecule GLP-1 receptor agonist targeting obesity and overweight patients with co-morbidities. The data include 36-week results from the Phase 2b ACCESS study and the exploratory ACCESS II study, as well as interim findings from ongoing Body Composition and ACCESS open-label extension (OLE) studies.

In the 36-week Phase 2b ACCESS study involving 230 participants, the 120 mg dose of aleniglipron achieved a significant placebo-adjusted mean weight loss of 11.3% (27.3 lbs), with 86% of participants reaching at least 5% weight loss and 70% achieving 10% or greater. The adverse event-related treatment discontinuation rate averaged 10.4% across all active doses.

The ACCESS II exploratory study assessed higher doses, up to 240 mg. At 36 weeks, the highest dose showed a placebo-adjusted mean weight loss of 15.3% (35.5 lbs), with all doses reaching statistical significance (p<0.0001). Gastrointestinal side effects such as nausea and vomiting were the most common adverse events, mostly emerging early in treatment.

Structure Therapeutics also reported interim data from the Body Composition and ACCESS OLE studies. Both trials explored a lower starting dose of 2.5 mg, which improved treatment tolerability and demonstrated no adverse event-related discontinuations during early dosing phases. OLE data further indicated continuous weight loss through 44 weeks without evidence of plateau.

The safety profile of aleniglipron was favorable, with no liver injury or QTc prolongation observed across studies. The findings support plans to initiate a Phase 3 program by mid-year, following a planned Type B meeting with the FDA to finalize trial design. The Phase 3 trial aims to evaluate multiple doses, starting with 2.5 mg titration up to 240 mg.

Raymond Stevens, Ph.D., CEO of Structure Therapeutics, emphasized that aleniglipron’s oral small molecule approach could provide an accessible, scalable treatment option for millions affected by obesity. Julio Rosenstock, MD, Chair of the ACCESS Steering Committee, highlighted the potential transformative impact of once-daily oral GLP-1 receptor agonists on global obesity care.

Structure Therapeutics continues to advance its metabolic franchise, leveraging structure-based drug discovery to develop novel small molecule therapies addressing chronic metabolic diseases with unmet needs.