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Obstructive Sleep ApneaPhase 3SURMOUNT-OSANCT05412004

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

A Phase 3 study testing Tirzepatide in people with Obstructive Sleep Apnea and Obesity, run by Eli Lilly and Company at 58 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obstructive Sleep Apnea, Obesity
What is being tested?
Tirzepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
469 participants
Where
58 sitesin 10 countries
Study dates
21 Jun 2022to 29 Mar 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 16Show fewer
  • 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)

Trial locations and contacts

58 sites in 10 countries.

58 sites in 10 countries

United States18 sites

  • NeuroTrials Research Inc

    Atlanta, Georgia, 30328

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

  • Gadolin Research

    Beaumont, Texas, 77702

  • Teradan Clinical Trials, LLC

    Brandon, Florida, 33511

  • NeuroScience Research Center

    Canton, Ohio, 44718

  • CTI-CRC

    Cincinnati, Ohio, 45212

  • Advanced Neuro Research Center - ANRC

    El Paso, Texas, 79912

  • Lillestol Research

    Fargo, North Dakota, 58104

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho, 83404

  • Brengle Family Medicine

    Indianapolis, Indiana, 46260

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Office 18

    Pittsburgh, Pennsylvania, 15236

  • Epic Medical Research

    Red Oak, Texas, 75154

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • Artemis Institute for Clinical Research

    Riverside, California, 92503

  • Sleep Therapy Research Center

    San Antonio, Texas, 78229

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

Other trials in United States

Mexico8 sites

  • Investigacion En Salud Y Metabolismo Sc

    Chihuahua City, 31217

  • Private Practice - Dr. Arechavaleta Granell Maria del Rosario

    Guadalajara, Jalisco, 44670

  • Unidad de Investigación Clínica y Atención Médica HEPA

    Guadalajara, Jalisco, 44670

  • RM Pharma Specialists

    Mexico City, Mexico City, 03100

  • Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

    Mexico City, Mexico City, 11650

  • Servicios Integrales Nova de Monterrey S.A. de C.V.

    San Nicolás de los Garza, Nuevo León, 66450

  • Unidad Médica para la Salud Integral

    San Nicolás de los Garza, Nuevo León, 66465

  • Arké SMO S.A de C.V

    Veracruz, 91910

Other trials in Mexico

Germany7 sites

  • Advanced Sleep Research

    Berlin, 10117

  • InnoDiab Forschung Gmbh

    Essen, North Rhine-Westphalia, 45136

  • Diabeteszentrum Hamburg West

    Hamburg, 22607

  • Siteworks GmbH

    Hanover, Lower Saxony, 30449

  • Institut für Diabetesforschung GmbH Münster

    Münster, North Rhine-Westphalia, 48145

  • RED-Institut GmbH

    Oldenburg in Holstein, Schleswig-Holstein, 23758

  • Lungenpraxis Schleswig

    Schleswig, Schleswig-Holstein, 24837

Other trials in Germany

Brazil6 sites

  • Núcleo de Pesquisa Clínica do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90430-001

  • CPCLIN

    São Paulo, São Paulo, 01228-200

  • CPQuali Pesquisa Clínica

    São Paulo, 01228-000

  • Hospital das Clinicas FMUSP

    São Paulo, 04266-010

  • BR Trials - Ensaios Clinicos e Consultoria

    São Paulo, 05003-090

  • Hospital das Clinicas FMUSP

    São Paulo, 05403-000

Other trials in Brazil

China6 sites

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011

  • Zhongshan Hospital,Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 214023

Other trials in China

Japan6 sites

  • Fukuwa Clinic

    Chuo-ku, Tokyo, 104-0031

  • Kirigaokatsuda Hospital

    Kitakyushu, Fukuoka, 802-0052

  • Koujunkai Daido Clinic

    Nagoya, Aichi-ken, 457-8511

  • Osaka Kaisei Hospital

    Osaka, 532-0003

  • Sakai City Medical Center

    Sakai, Osaka, 593-8304

  • RESM Respiratory and Sleep Medical Care Clinic

    Yokohama, Kanagawa, 222-0033

Other trials in Japan

Australia2 sites

  • Flinders University

    Bedford Park, South Australia, 5042

  • Woolcock Institute of Medical Research

    Sydney, New South Wales, 2037

Other trials in Australia

Czechia2 sites

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808

  • Praglandia s.r.o

    Prague, 150 00

Other trials in Czechia

Taiwan2 sites

  • China Medical University Hospital

    Taichung, 404332

  • National Cheng Kung University Hospital

    Tainan, 704

Other trials in Taiwan

Puerto Rico1 site

  • Puerto Rico Medical Research Center

    Hato Rey, Puerto Rico, 00917

Other trials in Puerto Rico

About this study

Official title: 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

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.

Being tested
Tirzepatide, Placebo
Medical subject headings
Sleep Apnea, Obstructive, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TirzepatideDrug

    Also called LY3298176

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT05412004
Study groupRoleWhat they receive
Tirzepatide MTD_GPI1ExperimentalParticipants 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
Receives: Drug: Tirzepatide
Placebo_GPI1Placebo comparatorParticipants not on PAP therapy received placebo QW as an SC injection for 52 weeks.
Receives: Drug: Placebo
Tirzepatide MTD_GPI2ExperimentalParticipants 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
Receives: Drug: Tirzepatide
Placebo_GPI2Placebo comparatorParticipants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Baseline, Week 52

Secondary outcomes (8)

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

    Percent Change From Baseline in AHI was evaluated.

    Measured: Baseline, Week 52

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

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

    Measured: Week 52

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

    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.

    Measured: Week 52

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

    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.

    Measured: Baseline, Week 52

  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)

    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).

    Measured: Baseline, Week 52

  6. Percent Change From Baseline in Body Weight

    Percent Change from Baseline in Body Weight was evaluated.

    Measured: Baseline, Week 52

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

    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.

    Measured: Baseline, Week 52

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

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

    Measured: Baseline, Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2022
  2. Study start21 Jun 2022
  3. Primary completion12 Mar 2024
  4. Study completion29 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
469 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05412004
Sponsor's protocol ID
18357
Other IDs
I8F-MC-GPIF, I8F-MC-GPI1, I8F-MC-GPI2, 2021-004552-41
Acronym
SURMOUNT-OSA
Status last verified
Apr 2025
First submitted
25 May 2022
Last updated
30 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Lin 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.

    PubMed 42774617

  • Falcon B, Xie CC, Redline S, Grunstein R, Turnbull CD, Rapoport DM, Wang H, Chakladar S, Dimitriadis GK, Lau E, Bednarik J, Liao B, Malhotra A. Association of tirzepatide with changes in OSA-related measures based on baseline characteristics - post hoc analyses of SURMOUNT-OSA. J Clin Sleep Med. 2026 Aug 31;22(1):155. doi: 10.1007/s44470-026-00162-z.

    PubMed 42675225

  • Kanu C, Shinde S, Falcon B, Bednarik J, Xie CC, Trice K, Weaver T. Changes in patient-reported outcomes and objective assessments based on baseline symptom severity in SURMOUNT-OSA: post-hoc analyses. Sleep. 2026 Oct 13;49(10):zsag184. doi: 10.1093/sleep/zsag184.

    PubMed 42412744

  • Shinde S, Kanu C, Varnado OJ, Bednarik J, Dennehy EB, Dias-Barbosa C, Taylor N. Patients' Experiences of Obstructive Sleep Apnea and Tirzepatide Treatment: An Exit Interview Study. Patient. 2026 Jul;19(4):601-614. doi: 10.1007/s40271-026-00808-3. Epub 2026 Mar 7.

    PubMed 41793578

  • Malhotra A, Grunstein R, Azarbarzin A, Sands S, Somers VK, Aronne LJ, Jastreboff AM, Lou J, Chakladar S, Dunn JP, Bunck MC, Bednarik J. Tirzepatide on obstructive sleep apnea-related cardiometabolic risk: secondary outcomes of the SURMOUNT-OSA randomized trial. Nat Med. 2026 Feb;32(2):653-659. doi: 10.1038/s41591-025-04071-1. Epub 2026 Jan 15.

    PubMed 41540105

  • Malhotra A, Grunstein RR, Azarbarzin A, Sands SA, Dang X, Chakladar S, Dunn JP, Falcon B, Bednarik J. Tirzepatide for sleep-disordered breathing in SURMOUNT-OSA: Time course and association with body weight. Sleep Med. 2025 Dec;136:106853. doi: 10.1016/j.sleep.2025.106853. Epub 2025 Oct 14.

    PubMed 41135142

  • Kanu C, Shinde S, Chakladar S, Dennehy EB, Weaver TE, Poon JL, Malhotra A. Effect of tirzepatide treatment on patient-reported outcomes among SURMOUNT-OSA participants with obstructive sleep apnea and obesity. Sleep Med. 2025 Oct;134:106719. doi: 10.1016/j.sleep.2025.106719. Epub 2025 Aug 6.

    PubMed 40774158

  • Malhotra A, Grunstein RR, Fietze I, Weaver TE, Redline S, Azarbarzin A, Sands SA, Schwab RJ, Dunn JP, Chakladar S, Bunck MC, Bednarik J; SURMOUNT-OSA Investigators. Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity. N Engl J Med. 2024 Oct 3;391(13):1193-1205. doi: 10.1056/NEJMoa2404881. Epub 2024 Jun 21.

    PubMed 38912654

  • Malhotra A, Bednarik J, Chakladar S, Dunn JP, Weaver T, Grunstein R, Fietze I, Redline S, Azarbarzin A, Sands SA, Schwab RJ, Bunck MC. Tirzepatide for the treatment of obstructive sleep apnea: Rationale, design, and sample baseline characteristics of the SURMOUNT -OSA phase 3 trial. Contemp Clin Trials. 2024 Jun;141:107516. doi: 10.1016/j.cct.2024.107516. Epub 2024 Mar 26.

    PubMed 38547961

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tirzepatide in people with Obstructive Sleep Apnea and Obesity, run by Eli Lilly and Company at 58 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, Mexico, Germany, Brazil, China and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Apnea-Hypopnea Index (AHI) (time frame: Baseline, Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05412004, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.

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