Announcement • Jun 06
Structure Therapeutics Announces Publication In Nature Medicine Highlighting Phase 2b ACCESS Program Of Aleniglipron For Obesity
Structure Therapeutics Inc. announced a publication in Nature Medicine detailing results from the Phase 2b ACCESS clinical trial of aleniglipron for the treatment of people living with obesity and/or overweight with at least one weight related co-morbidity. The Nature Medicine publication, titled, "Oral small molecule GLP-1 receptor agonist aleniglipron in people with overweight or obesity: a randomized, double-blind, placebo-controlled phase 2b trial," was released concurrent with an oral presentation during the American Diabetes Association’s 86th Scientific Sessions. The data highlights the efficacy from three maintenance dose levels in the core Phase 2b ACCESS study, as well as a predefined interim analysis of the open-label extension (OLE) safety study that demonstrated the durability of weight loss beyond 36 weeks, and improved tolerability from a lower 2.5 mg starting dose. The data from these studies provide support for the study design of the upcoming Phase 3 program which is expected to initiate in the third quarter of 2026. Aleniglipron is an oral, small-molecule glucagon-like peptide-1 receptor agonist (GLP1-RA) in development for the treatment of obesity. At Week 36, each of the three doses in the ACCESS study achieved statistical significance on the primary endpoint and all key secondary endpoints. Other cardiovascular risk factors showed improvement with aleniglipron, such as systolic and diastolic blood pressure, hsCRP, waist circumference and HbA1c. The interim analysis from the OLE study showed that patients continued to lose weight after a median follow up of 20 weeks, with weight loss of 13.3%, 16.2%, and 15.3% in the participants coming from 45 mg, 90 mg, and 120 mg aleniglipron arms from the double-blind treatment period, respectively. Adverse events (AEs) in the patients treated with aleniglipron are similar to those seen in the GLP-1 class of medicines. Gastrointestinal (GI) events were generally mild to moderate and decreased in frequency over time and most patient discontinuations occurred during the initial titrations in dose. There was no apparent dose-response relationship for the most common GI AEs across all aleniglipron treatment arms, and treatment discontinuations due to any treatment related adverse event (TEAE) were limited. The heat maps of dose levels overlaid with vomiting events add clarity to interpretation of the AE profile and add valuable insights into the participant experience on aleniglipron. Upon examination of each participant’s dosing across the study, it becomes clear that although some participants required dose interruptions or reductions, when the dose was re-initiated or up-titrated again, vomiting rarely recurred. This suggests that participants on aleniglipron may successfully restart treatment or continue to increase dosing after an interruption. This could potentially increase the likelihood to remain on treatment for extended periods of time, which is essential for a clinically meaningful treatment of obesity. Structure Therapeutics will have multiple other presentations related to its obesity pipeline, including amylin and combination data, at the ADA 86th Scientific Sessions. Details of the additional presentations are as follows: Title: Exploring a Lower Starting Dose of Aleniglipron, an Oral Small Molecule GLP-1RA, to Improve GI Tolerability in Obesity: Beyond the ACCESS Trials. Session: Late Breaking Poster Session (3101-LB). Date: Sunday, June 7. Time: 12:30 p.m. – 1:30 p.m. CT. Title: Combination Treatment of Oral Small Molecule GLP-1 Receptor Agonist Aleniglipron and Small Molecule Amylin Receptor Agonist ACCG-2671 Demonstrated Additional Weight Loss than Monotreatment in Obese NHPs. Session: Late Breaking Poster Session (3061-LB). Date: Sunday, June 7. Time: 12:30 p.m. – 1:30 p.m. CT. Title: Comparison of Conditioned Taste Avoidance Profiles between GLP-1 Peptides, Amylin Peptides, and Small Molecule Amylin Receptor Agonists. Session: Late Breaking Poster Session (3062-LB). Date: Sunday, June 7. Time: 12:30 p.m. – 1:30 p.m. CT. Title: Safety, Tolerability, and Efficacy of Aleniglipron in Doses up to 240 mg in People Living with Obesity: The Phase 2 ACCESS II Trial. Session: General Poster Session (2637-P). Date: Monday, June 8. Time: 12:30 p.m. – 1:30 p.m. CT.
