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Structure Therapeutics (GPCR) investor relations material
Structure Therapeutics Study Update summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Study design and objectives
Phase 2b ACCESS and supplementary studies evaluated efficacy, safety, and tolerability of Eleniglipron/Aleniglipron in adults with obesity or overweight plus comorbidities, using doses up to 240 mg over 36–44 weeks, with alternative titration schemes and exploratory studies at higher doses.
Participants were randomized to active drug (45, 90, 120 mg) or placebo, with a 5 mg starting dose and four-week titration steps; key endpoints included percent body weight reduction and secondary metabolic outcomes.
Over 500 participants were treated across all studies, including open-label extension and body composition studies using a lower 2.5 mg starting dose to improve tolerability.
Studies addressed weight loss durability, higher dosing, and improved tolerability with lower starting dose.
Phase 3 program is planned to start mid-2026, with an FDA meeting in early 2026 to finalize design.
Efficacy and weight loss outcomes
At 36 weeks, placebo-adjusted mean weight loss was 8.2% (45 mg), 9.8% (90 mg), and 11.3% (120 mg), with up to 15.3% at 240 mg in exploratory studies; all doses achieved statistical significance on primary and key secondary endpoints.
No evidence of weight loss plateau through 44 weeks; weight loss continued in open-label extension.
Over 70% of participants on 120 mg lost at least 10% of body weight, and nearly 40% lost at least 15%.
Clinically meaningful improvements in systolic blood pressure (-6.4 to -7.5 mmHg) and HbA1c (-0.28% to -0.37%) were observed, even in participants without diabetes.
Safety and tolerability
GI-related adverse events (nausea, vomiting) were most common, peaking early and mostly mild to moderate, with overall AE-related discontinuation rates of 7.7% to 13.3% (mean 10.4%) in Phase 2b.
No AE-related discontinuations occurred at higher doses (180/240 mg) after titration in ACCESS II and in studies using a 2.5 mg starting dose.
No cases of drug-induced liver injury, persistent liver enzyme elevations, or QTc prolongation were observed in over 500 patients.
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