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NCT05412004 · ClinicalTrials.gov registry record · Phase 3
Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 469
- Enrollment target
NCT05412004: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT05412004 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 469 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05412004, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 469 participants
- Enrollment target
Study 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.
Primary Outcome
AHI, Apnea-Hypopnea Index, is the number of apneas or hypopneas recorded via polysomnography during the study per hour of sleep. Apnea is defined as a cessation of airflow lasting at least 10 seconds, hypopnea as a decrease in airflow by at least 30% from baseline for at least 10 seconds occurring with a drop in oxygen saturation (SpO₂) by at least 4%. AHI values are categorized as 5-15 events/hr = mild; 15-\<30 events/hr = moderate; and ≥ 30 events/hr = severe. a significant reduction in values
Interventions
- DRUG Placebo
- DRUG Tirzepatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 469 participants |
| Start Date | 2022-06-21 |
| Est. Completion | 2024-03-29 |
| Phase | Phase 3 |
What the finished NCT05412004 record still lists
NCT05412004 is an interventional study that assigns participants to a tested intervention. The registered 469 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05412004 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05412004 about?
NCT05412004 is a clinical study titled "Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea". 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.
What is the current status of trial NCT05412004?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 469 participants. The study started on 2022-06-21. Estimated completion is 2024-03-29.
What interventions are being tested in trial NCT05412004?
The interventions under investigation include: Placebo (DRUG), Tirzepatide (DRUG).
Who is sponsoring clinical trial NCT05412004?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05412004's enrollment target sits among peer trials
469 815th of 2000 higher than 1,185 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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