Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea (SURMOUNT-OSA)

I8F-MC-GPIF -

The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP) therapy in GPI-1 and those who are and plan to stay on PAP therapy in GPI-2.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Obesity
What the trial is testing?
Tirzepatide
Could I receive a Placebo?
Yes
Enrollment Goal
469
Trial Dates
Jun 21, 2022 - Mar 29, 2024
How long will I be in the trial?
Your participation could last about 60 Weeks and may include up to 12 visits to the study center.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • For GPI1 : Participants who are unable or unwilling to use PAP therapy.Participants must not have used PAP for at least 4 weeks prior to screening

  • For GPI2 : Participants must have been on PAP therapy for at least 3 consecutive months prior to screening and plan to continue PAP therapy during the study

  • For both GPI1 and GPI2 : Participants must have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight

Participants Must Not:

  • For GPI2 : Participants must not have personal or job-related responsibilities, or in the opinion of the investigator have any situation, that would make it unsafe to stop PAP therapy for 7 days prior to PSG testing during the course of the study

  • For GPI2 : Participants must not be unwilling to stop PAP therapy for 7 days prior to PSG testing during the course of the study

  • For GPI1 and GPI2 : Female participants must not be pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed

  • For GPI1 and GPI2 : Participants must not have Type 1 diabetes or Type 2 diabetes

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