Positive topline data from its ACCESS study has led Structure Therapeutics to advance its oral GLP-1, aleniglipron, into phase 3 trials, scheduled for mid-2026.
The data includes 36-week data from the core phase 2b ACCESS study and the ongoing exploratory ACCESS II study, and interim data from the ongoing Body Composition study and the ACCESS open label extension (OLE) study.
In the phase 2b Access trial, a 120 mg dose led to a mean weight loss of 11.3% (27.3 lbs) and a 240 mg dose to 15.3% (35.5 lbs) at 36 weeks. Although the 120 mg dose led to 10.4% adverse event-related treatment discontinuation, there were no discontinuations when patients started with a 2.5 mg dose. The most common AEs were gastrointestinal (GI)-related and the two most common AEs in the titration phase were nausea and vomiting.
Aleniglipron is an investigational, once-daily, nonpeptide small molecule GLP-1 receptor agonist. The weight loss treatment is for patients with obesity or overweight with a weight-related comorbidity.