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A Phase 2, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Efficacy of Increasing Optimal Doses of Aleniglipron (GSBR-1290) in Participants Living With Obesity (Body Mass Index ≥ 30 kg/m2) or Overweight (Body Mass Index ≥ 27 kg/m2) With at Least One Weight-related Comorbidity (ACCESS II)

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Trial Profile

A Phase 2, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Efficacy of Increasing Optimal Doses of Aleniglipron (GSBR-1290) in Participants Living With Obesity (Body Mass Index ≥ 30 kg/m2) or Overweight (Body Mass Index ≥ 27 kg/m2) With at Least One Weight-related Comorbidity (ACCESS II)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 May 2026

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At a glance

  • Drugs Aleniglipron (Primary)
  • Indications Obesity
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms ACCESS II
  • Sponsors Gasherbrum Bio

Most Recent Events

  • 28 Apr 2026 Status changed from active, no longer recruiting to completed.
  • 16 Mar 2026 Results presented in the Structure Therapeutics Media Release.
  • 27 Feb 2026 According to Structure Therapeutics Media Release, The Company has planned an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to align on a Phase 3 registrational program with a starting titration dose of 2.5 mg and the intent to evaluate multiple maintenance doses. The Company anticipates initiating the Phase 3 program in the second half of 2026.

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