Structure Therapeutics Inc. (NASDAQ: GPCR) has released positive topline data from the Phase 2 ACCESS II trial of Aleniglipron, the once-daily oral small molecule glucagon-like peptide-1 (GLP-1) receptor agonist. The study demonstrated a significant placebo-adjusted mean weight loss of 16.3% (39 lbs) at the 180 mg dose and 16.0% (37 lbs) at the 240 mg dose at 44 weeks, with no evidence of weight loss plateau. Additionally, the ACCESS open label extension (OLE) study showed continued weight loss of up to 16.2% (40.5 lbs) with the 120 mg dose at 56 weeks, also with no evidence of weight loss plateau.
The updated interim data from the ACCESS OLE and body composition studies further supported improved tolerability and low study drug discontinuations due to adverse events, particularly with the lower 2.5 mg starting dose. The company is scheduled to hold an end-of-phase 2 meeting with the FDA in the second quarter of 2026, with phase 3 initiation remaining on track for the second half of 2026.
The Phase 2 ACCESS II study, which evaluated higher doses up to 240 mg, enrolled 85 adult participants living with obesity or overweight and at least one weight-related comorbidity. The study demonstrated statistically significant placebo-adjusted mean weight loss at 44 weeks compared to baseline for all active doses.
The company also conducted a body composition study to evaluate the effect of Aleniglipron on body fat loss over a 40-week period, with participants starting at a 2.5 mg dose and titrating up monthly to a target dose of 120 mg. The study showed that starting at a lower dose of 2.5 mg for the first four weeks supported a manageable tolerability profile and a 6.8% weight loss after a median follow-up of 20 weeks.
Furthermore, the ACCESS OLE study, following a randomized 36-week period, demonstrated continuing weight loss in all dose cohorts, with no evidence of weight loss plateau. Participants who received placebo in the initial double-blind portion and transitioned to Aleniglipron at a starting dose of 2.5 mg also showed meaningful improvement in key tolerability markers compared to the starting 5 mg titration dose in previous studies.
Aleniglipron demonstrated a compelling safety profile in more than 625 participants across all studies, with no cases of drug-induced liver injury, no persistent liver enzyme elevations, and no qtc prolongation.
The Phase 3 initiation, anticipated in the second half of 2026, is supported by data from the ACCESS, ACCESS II, body composition, and the ACCESS OLE studies. The company is set to finalize the Phase 3 design in a type B end-of-phase 2 meeting with the FDA scheduled for the second quarter of 2026.
The CEO of Structure Therapeutics, Raymond Stevens, emphasized the clear differentiation of Aleniglipron, stating that the weight loss observed across multiple studies reaffirms its potential to be a best-in-class oral GLP-1 receptor agonist. Dr. Julio Rosenstock, the Chair of the ACCESS Program Steering Committee, also expressed optimism about the weight-lowering data and the tolerability profile of the program, positioning it ready for phase 3 studies.
Structure Therapeutics Inc. is a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity. Aleniglipron is an investigational orally-available, once-daily, nonpeptide small molecule agonist of the GLP-1 receptor.
For additional information, please visit www.structuretx.com. Following these announcements, the company's shares moved 4.26%, and are now trading at a price of $88.64. For the full picture, make sure to review Structure Therapeutics's 8-K report.
