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Structure Therapeutics Doses First Patients in Phase 2b Obesity Trial of Oral GLP-1R Agonist GSBR-1290

• Structure Therapeutics initiates Phase 2b ACCESS trial to evaluate GSBR-1290, an oral GLP-1 receptor agonist, for obesity or overweight with comorbidities. • The ACCESS study will assess multiple doses of GSBR-1290 up to 120 mg over 36 weeks, using a 'low and slow' titration regimen for improved tolerability. • A parallel Phase 2 ACCESS II study will evaluate higher doses (180 and 240 mg) of GSBR-1290, with topline data from both trials expected in Q4 2025. • GSBR-1290 offers potential manufacturing advantages over peptide-based GLP-1R therapies, according to Structure Therapeutics' CEO.

Structure Therapeutics Inc. (NASDAQ: GPCR) has announced the dosing of the first patients in its Phase 2b ACCESS clinical study. This trial is designed to evaluate the efficacy and safety of GSBR-1290, an orally-available, nonpeptide small molecule glucagon-like-peptide-1 receptor (GLP-1R) agonist, in adults living with obesity or who are overweight with a weight-related comorbidity.
The Phase 2b ACCESS study is a randomized, double-blind, placebo-controlled trial aiming to enroll approximately 220 participants. It will assess multiple doses of GSBR-1290, up to 120 mg, administered with an optimized “low and slow” titration regimen over a 36-week period. The primary endpoint is the percent change in body weight from baseline to week 36.

ACCESS II Study

Complementing the ACCESS study, the Phase 2 ACCESS II trial will evaluate even higher doses of GSBR-1290 (180 and 240 mg) over 36 weeks. ACCESS II aims to enroll approximately 82 adults living with obesity, or overweight with at least one weight-related comorbidity, following the same titration schedule as the ACCESS study. The first patient in ACCESS II is expected to be dosed by the end of 2024.

Management Commentary

Raymond Stevens, Ph.D., Founder and CEO of Structure Therapeutics, stated, “We have designed the ACCESS and ACCESS II studies to generate a robust dataset to determine the target doses to move into Phase 3 clinical development with the goal of bringing GSBR-1290 to patients as rapidly as possible. In addition to its very competitive efficacy and tolerability profile, as an oral, nonpeptide small molecule GLP-1R agonist, we believe GSBR-1290 offers attractive manufacturing scalability advantages over peptide-based GLP-1R therapies, and we are excited to advance GSBR-1290 as our lead program.”
Blai Coll, M.D., Ph.D., Chief Medical Officer of Structure Therapeutics, added, “Our 36-week ACCESS study is designed to assess multiple therapeutic doses of GSBR-1290 with a start low and go slow 4-week titration approach to optimize tolerability and increase the likelihood of maximizing weight loss. Based on the data from our earlier studies, clean safety profile and proportional exposure of GSBR-1290, we are also initiating the ACCESS II study to evaluate higher doses of GSBR-1290. We look forward to data from both studies expected in the fourth quarter of 2025.”

Study Design Details

Participants in both the ACCESS and ACCESS II studies will begin with a 5mg dose of GSBR-1290 (or placebo), with a 4-week titration schedule to reach target doses. Secondary endpoints include safety and tolerability of the monthly titration scheme, as well as pharmacokinetics of GSBR-1290. Topline data from both studies are anticipated in the fourth quarter of 2025.
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Reference News

[1]
Structure Therapeutics Announces First Patients Dosed in Phase 2b ACCESS Clinical Study ...
globenewswire.com · Nov 13, 2024

Structure Therapeutics initiates Phase 2b ACCESS study evaluating GSBR-1290, an oral GLP-1R agonist for obesity, with to...

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