Trial · NCT05412004
Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea
NCT05412004, Phase 3, Completed, Eli Lilly and Company; results first posted 2025-04-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea. Trials, record NCT05412004. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05412004
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea
- NCT number
- NCT05412004
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 469 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Obstructive Sleep Apnea, Obesity
- Interventions
- Tirzepatide, Placebo
- First posted
- 2022-06-09
- Last updated
- 2025-04-30
- Other registries' IDs
- eudract:2021-004552-41
- Results first posted
- 2025-04-30
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Apnea-Hypopnea Index (AHI) | Baseline, Week 52 | 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 indicates a positive outcome. |
| Secondary | Percent Change From Baseline in Apnea-Hypopnea Index (AHI) | Baseline, Week 52 | Percent Change From Baseline in AHI was evaluated. |
| Secondary | Percentage of Participants With ≥50% AHI Reduction From Baseline | Week 52 | Percentage of participants achieving ≥50% AHI reduction from baseline to Week 52 was evaluated. |
| Secondary | Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10 | Week 52 | The percentage of participants with OSA remission (AHI \<5 events per hour of sleep) or with mild OSA without excessive daytime sleepiness (AHI 5-14 events per hour of sleep with ESS ≤10) at Week 52 was evaluated. The ESS is used to assess improvements in excessive daytime sleepiness from baseline to Week 52. The ESS is an 8-item, participant-completed measure that asks the participant to rate, on a scale of 0 (no chance of dozing) to 3 (high chance of dozing), their usual chances of dozing in 8 different daytime situations, with a recall period of "in recent times." The ESS total score is the sum of the 8-item scores and ranges from 0 to 24, with higher scores indicating greater daytime sleepiness. |
| Secondary | Change From Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% Min/Hour) | Baseline, Week 52 | SASHB was determined by measuring the respiratory event-associated area under the curve for oxygen desaturation from pre-event baseline and represents the cumulative burden of intermittent hypoxia caused by OSA-related sleep-disordered breathing at sleep. |
| Secondary | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Sleep-Related Impairment 8a (PROMIS SRI) and PROMIS Short Form Sleep Disturbance 8b (PROMIS SD) | Baseline, Week 52 | PROMIS SRI consists of 8 items that assess self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and perceived functional impairments associated with sleep problems. PROMIS SRI has a recall period of "in the past 7 days" and each item is rated on a 5-point scale from "not at all" to "very much." PROMIS SD consists of 8 items that assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. PROMIS SD has a recall period of "in the past 7 days" and each item is rated on a 5-point scale ranging from "not at all" to "very much," "never" to "always," or "very poor" to "very good." For both PROMIS SRI and PROMIS SD, item responses are used to generate T-scores which are standardized scores with a mean of 50 and a standard deviation of 10 (score range cannot be specified for T-scores). Higher T-scores indicate worse outcomes; more sleep-related impairment (PROMIS SRI) or more sleep disturbance (PROMIS SD). |
| Secondary | Percent Change From Baseline in Body Weight | Baseline, Week 52 | Percent Change from Baseline in Body Weight was evaluated. |
| Secondary | Change From Baseline in High Sensitivity C Reactive Protein (hsCRP) Concentration | Baseline, Week 52 | HsCRP is a marker for inflammation and was measured from blood samples to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. |
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 48 | Change in systolic blood pressure from baseline to Week 48 was evaluated. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Apnea-Hypopnea Index (AHI) | Baseline, Week 52 | Modified intent-to-treat (mITT) population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome. | events per hour | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apnea-Hypopnea Index (AHI) | Baseline, Week 52 | mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome. | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With ≥50% AHI Reduction From Baseline | Week 52 | mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10 | Week 52 | mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% Min/Hour) | Baseline, Week 52 | mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome. | %.min/hr | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Sleep-Related Impairment 8a (PROMIS SRI) and PROMIS Short Form Sleep Disturbance 8b (PROMIS SD) | Baseline, Week 52 | mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome. | T score | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Body Weight | Baseline, Week 52 | mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in High Sensitivity C Reactive Protein (hsCRP) Concentration | Baseline, Week 52 | mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome. | Milligram per liter (mg/L) | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 48 | mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome. | Millimeters of mercury (mm Hg) | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Apnea-Hypopnea Index (AHI) | Tirzepatide MTD_GPI1 | -25.25 | Standard Error 2.06 | events per hour | |
| Change From Baseline in Apnea-Hypopnea Index (AHI) | Placebo_GPI1 | -5.25 | Standard Error 2.11 | events per hour | |
| Change From Baseline in Apnea-Hypopnea Index (AHI) | Tirzepatide MTD_GPI2 | -29.27 | Standard Error 1.99 | events per hour | |
| Change From Baseline in Apnea-Hypopnea Index (AHI) | Placebo_GPI2 | -5.51 | Standard Error 2.21 | events per hour | |
| Percent Change From Baseline in Apnea-Hypopnea Index (AHI) | Tirzepatide MTD_GPI1 | -50.68 | Standard Error 5.90 | percentage change | |
| Percent Change From Baseline in Apnea-Hypopnea Index (AHI) | Placebo_GPI1 | -3.03 | Standard Error 7.07 | percentage change | |
| Percent Change From Baseline in Apnea-Hypopnea Index (AHI) | Tirzepatide MTD_GPI2 | -58.72 | Standard Error 5.28 | percentage change | |
| Percent Change From Baseline in Apnea-Hypopnea Index (AHI) | Placebo_GPI2 | -2.50 | Standard Error 6.95 | percentage change | |
| Percentage of Participants With ≥50% AHI Reduction From Baseline | Tirzepatide MTD_GPI1 | 61.22 | percentage of participants | ||
| Percentage of Participants With ≥50% AHI Reduction From Baseline | Placebo_GPI1 | 18.96 | percentage of participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tirzepatide MTD_GPI1 | 114 | |
| Overall Study | STARTED | Placebo_GPI1 | 120 | |
| Overall Study | STARTED | Tirzepatide MTD_GPI2 | 120 | |
| Overall Study | STARTED | Placebo_GPI2 | 115 | |
| Overall Study | Received at Least One Dose of Study Drug | Tirzepatide MTD_GPI1 | 114 | |
| Overall Study | Received at Least One Dose of Study Drug | Placebo_GPI1 | 120 | |
| Overall Study | Received at Least One Dose of Study Drug | Tirzepatide MTD_GPI2 | 119 | |
| Overall Study | Received at Least One Dose of Study Drug | Placebo_GPI2 | 114 | |
| Overall Study | COMPLETED | Tirzepatide MTD_GPI1 | 101 | |
| Overall Study | COMPLETED | Placebo_GPI1 | 86 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events1,608
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Tirzepatide MTD_GPI1 | 1 | 114 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo_GPI1 | 0 | 120 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Tirzepatide MTD_GPI2 | 0 | 119 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo_GPI2 | 2 | 114 | 2 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Tirzepatide MTD_GPI1 | 0 | 114 | 0 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Placebo_GPI1 | 0 | 120 | 0 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Tirzepatide MTD_GPI2 | 1 | 119 | 1 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Placebo_GPI2 | 0 | 114 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Tirzepatide MTD_GPI1 | 0 | 114 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo_GPI1 | 0 | 120 | 0 |
1 to 10 of 1,608Source ClinicalTrials.gov
See all 1,608 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tirzepatide MTD_GPI1 | 0 | 114 |
| Total, all-cause mortality | Placebo_GPI1 | 0 | 120 |
| Total, all-cause mortality | Tirzepatide MTD_GPI2 | 0 | 119 |
| Total, all-cause mortality | Placebo_GPI2 | 0 | 114 |
| Total, other adverse events | Tirzepatide MTD_GPI1 | 91 | 114 |
| Total, other adverse events | Placebo_GPI1 | 91 | 120 |
| Total, other adverse events | Tirzepatide MTD_GPI2 | 98 | 119 |
| Total, other adverse events | Placebo_GPI2 | 82 | 114 |
| Total, serious adverse events | Tirzepatide MTD_GPI1 | 9 | 114 |
| Total, serious adverse events | Placebo_GPI1 | 7 | 120 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05412004
GET https://conductscience.org/api/trials/v1/NCT05412004/results?page=2