At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 469 enrolled
Drug / intervention
Tirzepatide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Tirzepatide and Placebo for Obstructive Sleep Apnea and Obesity. Completed, enrolled 469 participants across 58 sites in 10 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstructive Sleep Apnea, Obesity
CountriesAustralia, Brazil, China, Czechia, Germany, Japan, Mexico, Puerto Rico, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedJun 2022
Enrollment StartJun 2022
Primary CompletionMar 2024
Study CompletionMar 2024
TodayJul 2026
First PostedJun 9, 2022
Enrollment StartJun 21, 2022
Primary CompletionMar 12, 2024
Study CompletionMar 29, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 4.1 years ago
Interventions
Tirzepatidedrug
Administered SC
Placebodrug
Administered SC