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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name SURMOUNT-OSA

NCTNCT05412004 (opens ClinicalTrials.gov in a new tab)Other id18357Other idI8F-MC-GPIFOther idI8F-MC-GPI1Other idI8F-MC-GPI2
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
469 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
10 countries

United States, Australia, Brazil, China, Czechia, Germany, Japan, Mexico, Puerto Rico, Taiwan

Start
21 Jun 2022
Primary completion
12 Mar 2024
Completion
29 Mar 2024
First posted
9 Jun 2022
Last update posted
30 Apr 2025
Conditions
Obstructive Sleep Apnea · Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025
  1. Ph 3

    SURMOUNT-OSA

    NCT05412004

    21 Jun 2022 to 29 Mar 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TirzepatideDrug
  • PlaceboDrug

Arms4

  • Experimental

    Tirzepatide MTD_GPI1

    Participants not on positive airway pressure (PAP) therapy received a maximum tolerated dose (MTD) of 10 milligrams (mg) or 15 mg of Tirzepatide once weekly (QW) as a subcutaneous (SC) injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks

  • Placebo comparator

    Placebo_GPI1

    Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.

  • Experimental

    Tirzepatide MTD_GPI2

    Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks

  • Placebo comparator

    Placebo_GPI2

    Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Apnea-Hypopnea Index (AHI)

    Time frame · Baseline, Week 52

    Registry description

    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 outcomes(8)

  1. Percent Change From Baseline in Apnea-Hypopnea Index (AHI)

    Time frame · Baseline, Week 52

    Registry description

    Percent Change From Baseline in AHI was evaluated.

  2. Percentage of Participants With ≥50% AHI Reduction From Baseline

    Time frame · Week 52

    Registry description

    Percentage of participants achieving ≥50% AHI reduction from baseline to Week 52 was evaluated.

  3. Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10

    Time frame · Week 52

    Registry description

    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.

  4. Change From Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% Min/Hour)

    Time frame · Baseline, Week 52

    Registry description

    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.

  5. 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)

    Time frame · Baseline, Week 52

    Registry description

    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).

  6. Percent Change From Baseline in Body Weight

    Time frame · Baseline, Week 52

    Registry description

    Percent Change from Baseline in Body Weight was evaluated.

  7. Change From Baseline in High Sensitivity C Reactive Protein (hsCRP) Concentration

    Time frame · Baseline, Week 52

    Registry description

    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.

  8. Change From Baseline in Systolic Blood Pressure (SBP)

    Time frame · Baseline, Week 48

    Registry description

    Change in systolic blood pressure from baseline to Week 48 was evaluated.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Week 52

Change From Baseline in Apnea-Hypopnea Index (AHI)

GroupValue (events per hour)Spread
Tirzepatide MTD_GPI1-25.252.06
Placebo_GPI1-5.252.11
Tirzepatide MTD_GPI2-29.271.99
Placebo_GPI2-5.512.21
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Baseline, Week 52

Percent Change From Baseline in Apnea-Hypopnea Index (AHI)

GroupValue (percentage change)Spread
Tirzepatide MTD_GPI1-50.685.90
Placebo_GPI1-3.037.07
Tirzepatide MTD_GPI2-58.725.28
Placebo_GPI2-2.506.95
Secondary outcomeNumber· Week 52

Percentage of Participants With ≥50% AHI Reduction From Baseline

GroupValue (percentage of participants)
Tirzepatide MTD_GPI161.22
Placebo_GPI118.96
Tirzepatide MTD_GPI272.40
Placebo_GPI223.25
Secondary outcomeNumber· Week 52

Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10

GroupValue (percentage of participants)
Tirzepatide MTD_GPI142.17
Placebo_GPI115.88
Tirzepatide MTD_GPI250.24
Placebo_GPI214.33
Secondary outcomeGeometric least squares mean· Baseline, Week 52

Change From Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% Min/Hour)

GroupValue (%.min/hr)Spread
Tirzepatide MTD_GPI1-95.194.081
Placebo_GPI1-25.079.804
Tirzepatide MTD_GPI2-102.983.758
Placebo_GPI2-41.6911.313
Secondary outcomeLeast squares mean· Baseline, Week 52

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)

GroupValue (T score)Spread
Tirzepatide MTD_GPI1-4.470.69
Placebo_GPI1-2.440.70
Tirzepatide MTD_GPI2-6.980.82
Placebo_GPI2-3.080.88
Secondary outcomeLeast squares mean· Baseline, Week 52

Percent Change From Baseline in Body Weight

GroupValue (Percent change)Spread
Tirzepatide MTD_GPI1-17.650.69
Placebo_GPI1-1.560.68
Tirzepatide MTD_GPI2-19.620.71
Placebo_GPI2-2.340.74
Secondary outcomeGeometric least squares mean· Baseline, Week 52

Change From Baseline in High Sensitivity C Reactive Protein (hsCRP) Concentration

GroupValue (Milligram per liter (mg/L))Spread
Tirzepatide MTD_GPI1-1.420.151
Placebo_GPI1-0.700.203
Tirzepatide MTD_GPI2-1.370.130
Placebo_GPI2-0.330.236

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Tirzepatide MTD_GPI1Participants not on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.0 / 1149 / 11491 / 114
Placebo_GPI1Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.0 / 1207 / 12091 / 120
Tirzepatide MTD_GPI2Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.0 / 1197 / 11998 / 119
Placebo_GPI2Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.0 / 11412 / 11482 / 114

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies7

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Randomized controlled trial · 2026

6 results

Tirzepatide on obstructive sleep apnea-related cardiometabolic risk: secondary outcomes of the SURMOUNT-OSA randomized trial.

Malhotra et al. 2026Nature medicinecited by 15

PMID 41540105PMC12920140DOI 10.1038/s41591-025-04071-1PUB-41540105

Free to read · publisher termsCC BY-NC-ND6 results
Read at sourceSee results (6)

Indexing hint: Randomized controlled trial · 2026

9 results

Association of tirzepatide with changes in OSA-related measures based on baseline characteristics - post hoc analyses of SURMOUNT-OSA.

Falcon et al. 2026Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine

PMID 42675225PMC13530102DOI 10.1007/s44470-026-00162-zPUB-42675225

CC BY9 results
Download PDFSee results (9)

Indexing hint: Randomized controlled trial · 2025

8 results

Effect of tirzepatide treatment on patient-reported outcomes among SURMOUNT-OSA participants with obstructive sleep apnea and obesity.

Kanu et al. 2025Sleep medicinecited by 17

PMID 40774158PMC12720398DOI 10.1016/j.sleep.2025.106719PUB-40774158

CC BY8 results
Download PDFSee results (8)

Indexing hint: Randomized controlled trial · 2025

6 results

Tirzepatide for sleep-disordered breathing in SURMOUNT-OSA: Time course and association with body weight.

Malhotra et al. 2025Sleep medicinecited by 9

PMID 41135142PMC12723708DOI 10.1016/j.sleep.2025.106853PUB-41135142

Rights unknown6 results
Source linkSee results (6)

Indexing hint: Clinical trial · 2024

Tirzepatide for the treatment of obstructive sleep apnea: Rationale, design, and sample baseline characteristics of the SURMOUNT -OSA phase 3 trial.

Malhotra et al. 2024Contemporary clinical trialscited by 67

PMID 38547961PMC11168245DOI 10.1016/j.cct.2024.107516PUB-38547961

Free to read · publisher termsCC BY-NC-ND
Read at source

More studies

2 studies on this page

PubMed tag: none · 2026

Patients' Experiences of Obstructive Sleep Apnea and Tirzepatide Treatment: An Exit Interview Study.

Shinde et al. 2026The patient

PMID 41793578PMC13287229DOI 10.1007/s40271-026-00808-3PUB-41793578

Free to read · publisher termsCC BY-NC
Read at source

Indexing hint: Randomized controlled trial · 2024

Corrected

Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity.

Malhotra et al. 2024The New England journal of medicinecited by 616

PMID 38912654PMC11598664DOI 10.1056/nejmoa2404881PUB-38912654

Rights unknown
Source linkRead the notice

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedLin YN, Sun XW, Dai SJ, Zhuang HX, Liu JJ, Li QY. Association between early body weight reduction and treatment outcomes in participants with obstructive sleep apnoea and obesity: a post hoc analysis of SURMOUNT-OSA trials. EClinicalMedicine. 2026 Sep 15;100:104203. doi: 10.1016/j.eclinm.2026.104203. eCollection 2026 Oct. PMID 42774617

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: For GPI1 Participants: \- 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: \- 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: * Have an AHI ≥15 on PSG as part of the trial at screening * Have a body mass index (BMI) ≥30 kilogram/square meter (kg/m²) * Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight Exclusion Criteria: For GPI2 Participants: * 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 * Are unwilling to stop PAP therapy for 7 days prior to polysomnography (PSG) testing during the course of the study For GPI1 and GPI2 Participants: * Female participants must not be pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed. * Have type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), history of ketoacidosis, or hyperosmolar state/coma. * Have HbA1c ≥ 6.5% (≥ 48 mmol/mol) at baseline * Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing at time of baseline * Have significant craniofacial abnormalities that may affect breathing at baseline * Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration * Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia. * Active device treatment of OSA other than PAP therapy (for example, dental appliance), or other treatment, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at baseline and throughout the study. * Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator. * Have a self-reported change in body weight \>5 kg within 3 months prior to screening * Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed more than 1 year prior to screening) * Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months (for example, mucosal ablation, gastric artery embolization, intragastric balloon, and duodenal-jejunal bypass sleeve)

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