Structure Therapeutics has reported positive topline results from the ACCESS clinical programme for its investigational oral glucagon-like-peptide-1 (GLP-1) receptor agonist, aleniglipron, targeting adults with obesity or are overweight and at least one weight-related comorbidity.
In the core Phase IIb ACCESS study, participants receiving aleniglipron at the 120mg dose experienced a statistically significant placebo-adjusted mean weight loss of 11.3% at 36 weeks. The adverse event-related treatment discontinuation rate across all active groups was 10.4%.
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The study included 230 adult participants who had obesity with a body mass index (BMI) of 30kg/m² or higher, or were overweight with a BMI of 27kg/m² or higher, each with at least one weight-related comorbidity.
Participants began treatment at 5mg, with dose escalation to 45mg, 90mg, or 120mg once a day. After 36 weeks, 86% of those receiving the 120mg dose achieved a minimum of 5% weight loss while 70% reported weight loss of at least 10%.
In the exploratory ACCESS II trial, the 240mg dose showed a placebo-adjusted mean weight loss of up to 15.3% at 36 weeks. Aleniglipron showed a tolerability profile that is consistent with the GLP-1 receptor agonist class.
This study included 85 adults to assess aleniglipron doses of 120mg, 180mg and 240mg.
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By GlobalDataIn a separate body composition study involving 71 participants, initiating treatment with a lower 2.5mg dose enhanced tolerability, and no adverse event-related discontinuations occurred during the initial dosing period.
The ACCESS open-label extension indicated that weight loss persisted through 44 weeks, with enhanced tolerability observed when treatment commenced at an initial 2.5mg dose.
Throughout all studies, there were no reports of drug-induced liver injury, ongoing liver enzyme increases, or QTc prolongation.
Structure Therapeutics intends to seek a Type B End-of-Phase II meeting with the US Food and Drug Administration (FDA) in the first half of next year, for finalising Phase III design.
Structure Therapeutics CEO Raymond Stevens said: “The topline results presented today show that aleniglipron is differentiated and delivered clinically meaningful, competitive and dose-dependent weight loss with a safety profile appropriate for chronic use in a disease that impacts millions of people.”
