Structure Therapeutics Begins Phase 2b Study of Oral GLP-1 Agonist GSBR-1290 for Obesity

Structure Therapeutics Inc. has announced the initiation of patient dosing in its Phase 2b ACCESS study, which is investigating the drug GSBR-1290 in individuals with obesity or overweight conditions accompanied by weight-related comorbidities. The study is designed to evaluate multiple doses of the orally-administered glucagon-like-peptide-1 receptor (GLP-1R) agonist, which has already shown promising weight loss results and good safety and tolerability in earlier research.

The comprehensive development program also includes a Phase 2 ACCESS II study, which will assess even higher doses of GSBR-1290. The ACCESS study aims to enroll around 220 adults and will evaluate doses up to 120 mg of GSBR-1290 over a 36-week period using a gradual titration regimen. The ACCESS II study will involve about 82 participants and will focus on higher doses, specifically 180 mg and 240 mg, over the same duration. Both studies are anticipated to yield topline data by the fourth quarter of 2025.

Dr. Raymond Stevens, the founder and CEO of Structure Therapeutics, emphasized that these studies are designed to identify the most effective doses for Phase 3 clinical trials with the objective of delivering GSBR-1290 to patients quickly. He pointed out the drug's competitive efficacy and tolerability, as well as its manufacturing advantages over peptide-based GLP-1R therapies. Dr. Stevens noted that GSBR-1290 is part of a broader portfolio of oral small molecules targeting obesity, with additional candidates expected to be announced soon.

Dr. Blai Coll, the Chief Medical Officer of Structure Therapeutics, explained that the 36-week ACCESS study employs a "start low and go slow" titration approach to optimize tolerability and enhance weight loss outcomes. This approach begins with a low dose of GSBR-1290 or placebo and gradually increases to target doses of 45 mg, 90 mg, and 120 mg. The primary endpoint of the study is the percentage change in body weight from baseline to week 36, while secondary endpoints include the safety and tolerability of the titration regimen and the pharmacokinetics of the drug.

The ACCESS II study follows a similar design but evaluates higher target doses of GSBR-1290. Participants will start with 5 mg and follow a 4-week titration schedule up to 120 mg, 180 mg, and 240 mg. Both studies are double-blind and placebo-controlled, ensuring rigorous assessment of the drug's efficacy and safety.

GSBR-1290 is a small molecule GLP-1R agonist, a drug class validated for treating obesity and type 2 diabetes mellitus (T2DM). Developed through Structure Therapeutics' structure-based drug discovery platform, GSBR-1290 selectively activates the G-protein signaling pathway, offering potential advantages over traditional peptide therapies in terms of manufacturing scalability and patient accessibility. The company's pipeline includes other next-generation oral small molecules, such as amylin receptor agonists and combination GLP-1 receptor agonist candidates, which target various metabolic and cardiopulmonary conditions.

Structure Therapeutics is committed to advancing innovative treatments for chronic conditions with unmet medical needs. Their structure-based drug discovery platform has enabled the development of a robust pipeline of proprietary small molecule compounds designed to overcome the limitations of biologic and peptide therapies, making them more accessible to patients globally.