Structure Therapeutics reports weight loss data for obesity drug candidate
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Structure Therapeutics Inc. (NASDAQ: GPCR) announced results from clinical trials of aleniglipron, an oral small molecule drug candidate for obesity treatment. The company reported placebo-adjusted mean weight loss of 11.3% with the 120 mg dose and up to 15.3% with the 240 mg dose at 36 weeks in separate studies.
The Phase 2b ACCESS study enrolled 230 participants with obesity or overweight conditions with weight-related comorbidities. Participants received daily doses of 45 mg, 90 mg, or 120 mg of aleniglipron. The 120 mg dose group showed a 12.1% mean weight reduction compared to 0.8% in the placebo group. All dose groups achieved statistical significance with p-values less than 0.0001.
In the exploratory ACCESS II study with 85 participants, higher doses of 120 mg, 180 mg, and 240 mg were tested. The 240 mg dose group demonstrated a 14.2% mean weight reduction compared to a 1.0% weight gain in the placebo group, resulting in a placebo-adjusted reduction of 15.3%.
Adverse event-related treatment discontinuation rates averaged 10.4% across all active treatment arms in the Phase 2b study. The most common side effects were gastrointestinal issues including nausea and vomiting, consistent with other GLP-1 receptor agonist medications. When participants began treatment with a lower 2.5 mg starting dose instead of 5 mg, no treatment discontinuations due to adverse events were observed.
The company plans to request a meeting with the FDA in the first half of 2026 to discuss Phase 3 trial design and expects to begin Phase 3 studies by mid-2026. The Phase 3 program is designed to start with a 2.5 mg dose and evaluate multiple doses up to 240 mg.
Aleniglipron is designed as an oral alternative to injectable GLP-1 receptor agonist medications currently used for obesity treatment.
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