Structure Therapeutics has reported positive topline data from its phase 2 ACCESS II trial of its oral GLP-1 drug, aleniglipron.
The placebo-adjusted mean weight loss at 44 weeks was 16.3% (39 lbs) for patients taking 180 mg and 16.0% (37 lbs) for those taking 240 mg. In addition, interim data from the ACCESS open label extension (OLE) showed no evidence of a weight loss plateau and demonstrated continued weight loss at 56 weeks.
The once-daily oral small molecule GLP-1 receptor agonist was tested on patients with obesity or overweight with a related comorbidity. It has demonstrated the highest efficacy of any oral GLP-1RA, comparable efficacy to injectable GLP-1RAs, and a tolerability profile consistent with the GLP-1 receptor agonist class.
Structure has a Type B End-of-Phase 2 meeting scheduled with the FDA for Q2 2026, where it will finalize phase 3 design. The company expects to start phase 3 trials in the second half of the year.