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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: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 18 Dec 2025

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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

  • 08 Dec 2025 According to Structure Therapeutics Media Release, The Company plans to request a Type B End-of-Phase 2 meeting with the United States Food and Drug Administration (FDA) in the first half of 2026 to finalize the Phase 3 design
  • 08 Dec 2025 According to Structure Therapeutics Media Release, Primary endpoint has been met. (Percent change in body weight from baseline to week 36.)
  • 08 Dec 2025 Results presented in the Structure Therapeutics Media Release

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