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A Master Protocol to Investigate the Efficacy and Safety of Tirzepatide Once Weekly in Participants Who Have Obstructive Sleep Apnea and Obesity: A Randomized, Double-Blind, Placebo-Controlled Trial

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Trial Profile

A Master Protocol to Investigate the Efficacy and Safety of Tirzepatide Once Weekly in Participants Who Have Obstructive Sleep Apnea and Obesity: A Randomized, Double-Blind, Placebo-Controlled Trial

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 May 2025

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At a glance

  • Drugs Tirzepatide (Primary)
  • Indications Obesity; Sleep apnoea syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms SURMOUNT-OSA
  • Sponsors Eli Lilly and Company

Most Recent Events

  • 20 Dec 2024 According to an Eli Lilly and Company Media Release, the U.S. Food and Drug Administration (FDA) approved Zepbound (tirzepatide) as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. based on results from this trial.
  • 21 Jun 2024 According to an Eli Lilly and Company Media Release, the company has submitted Lilly submitted tirzepatide for the treatment of moderate-to-severe OSA and obesity to the U.S. Food and Drug Administration (FDA) with regulatory action anticipated as early as the end of this year.
  • 21 Jun 2024 Results presented in the Eli Lilly and Company Media Release.

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