NCT05412004

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

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: Phase 3
• Study type: Interventional
• Enrollment: 469 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with moderate to severe obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP) therapy in GPI1 and those who are and plan to stay on PAP therapy in GPI2.

Conditions

• Obstructive Sleep Apnea
• Obesity

Interventions

Type	Name	Description
DRUG	Tirzepatide	Administered SC
DRUG	Placebo	Administered SC

Timeline

• Start date: 2022-06-21
• Primary completion: 2024-03-12
• Completion: 2024-03-29
• First posted: 2022-06-09
• Last updated: 2025-04-30
• Results posted: 2025-04-30

Locations

58 sites across 10 countries: United States, Australia, Brazil, China, Czechia, Germany, Japan, Mexico, Puerto Rico, Taiwan

Regulatory

• FDA-regulated drug study