Structure Therapeutics Reports Positive Topline Data from ACCESS Program for its Once-Daily Oral Small Molecule GLP-1 Receptor Agonist, Aleniglipron

Core Insights - Structure Therapeutics announced positive topline data from the ACCESS clinical program of aleniglipron, focusing on obesity treatment with significant weight loss results [2][4] - Aleniglipron demonstrated a clinically meaningful and statistically significant placebo-adjusted mean weight loss of 11.3% (27.3 lbs) at the 120 mg dose in the Phase 2b ACCESS study [3][5] - The company plans to advance aleniglipron into Phase 3 clinical development by mid-2026, supported by comprehensive data from multiple studies [14] Phase 2b ACCESS Study - The Phase 2b ACCESS study involved 230 adult participants with obesity or overweight, showing a 10.4% adverse event-related treatment discontinuation rate [5][7] - At 36 weeks, the mean percent change in body weight for the 120 mg dose was -12.1% compared to baseline, with a placebo-adjusted mean change of -11.3% [6] - Key secondary endpoints indicated that 86% of participants in the 120 mg cohort achieved at least 5% weight loss [6] Exploratory ACCESS II Study - The ACCESS II study evaluated higher doses of aleniglipron, with a placebo-adjusted mean weight loss of up to 15.3% (35.5 lbs) at the 240 mg dose [3][9] - Each dose cohort in the ACCESS II study met statistical significance compared to placebo, with the 240 mg group showing a mean percent change of -14.2% [9] Body Composition Study - A body composition study is assessing the effect of aleniglipron starting at a lower 2.5 mg dose, showing improved tolerability with no adverse event-related treatment discontinuations [10][12] - Initial data indicated that starting at a lower dose significantly improved tolerability compared to the 5 mg starting dose used in other studies [10] ACCESS Open-Label Extension Study - The ACCESS OLE study demonstrated continued weight loss in all dose cohorts out to 44 weeks, with no evidence of a weight loss plateau [11] - Participants who transitioned from placebo to aleniglipron at a 2.5 mg starting dose also showed improved tolerability [12] Safety Profile - Aleniglipron exhibited a favorable safety profile across all studies, with no cases of drug-induced liver injury or persistent liver enzyme elevations [13] - The most common adverse events were gastrointestinal-related, consistent with the GLP-1 receptor agonist class [7][9] Future Development Plans - The company plans to request a Type B End-of-Phase 2 meeting with the FDA in the first half of 2026 to finalize the Phase 3 trial design [14] - The Phase 3 program is expected to evaluate multiple doses up to 240 mg, with an anticipated initiation by mid-2026 [14]