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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 23 Dec 2025

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At a glance

  • Drugs HRS 9531 (Primary)
  • Indications Obesity
  • Focus Registrational; Therapeutic Use
  • Sponsors Kailera Therapeutics

Most Recent Events

  • 18 Dec 2025 Status changed from planning to not yet recruiting.
  • 21 Nov 2025 New trial record
  • 14 Oct 2025 According to Kailera Therapeutics media release, company completed End-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA) and plans to initiate its global Phase 3 program by year end. company look forward to starting our global Phase 3 trials of KAI-9531 by the end of this year.

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