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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05412004
Collaborator
(none)
412
Enrollment
67
Locations
2
Arms
20.3
Anticipated Duration (Months)
6.1
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP) therapy in GPI-1 and those who are and plan to stay on PAP therapy in GPI-2.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
412 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 21, 2022
Anticipated Primary Completion Date :
Feb 29, 2024
Anticipated Study Completion Date :
Feb 29, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tirzepatide Maximum Tolerated Dose

Participants will receive a low dose and then increase to a maximum tolerated dose 1 or dose 2 subcutaneously (SC). GPI1: Participants are unwilling or unable to use PAP therapy. GPI2: Participants are on PAP therapy.

Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

    		•
    Placebo Comparator: Placebo

    Participants will receive placebo SC GPI1: Participants are unwilling or unable to use PAP therapy. GPI2: Participants are on PAP therapy.

    Drug: Placebo
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Percent Change from Baseline in Apnea-Hypopnea Index (AHI) [Baseline, Week 52]

    Secondary Outcome Measures

    1. A Hierarchical Combination of Functional Outcomes of Sleep Questionnaire (FOSQ) 10 Score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score [Baseline (Week 0) to Study Completion (Estimated Up to 52 Weeks)]

      A hierarchical combination of change from baseline in the FOSQ 10 score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score will be assessed by the win ratio. The reported unit will be the total "wins" for each treatment group from performing a hierarchical comparison of the components.

    2. Percentage of Participants with ≥50% AHI Reduction from Baseline [Week 52]

    3. Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 [Week 52]

    4. Percent Change from Baseline in Body Weight [Baseline, Week 52]

    5. Change from Baseline in Systolic Blood Pressure (SBP) [Baseline, Week 52]

    6. Change from Baseline in High Sensitivity C reactive Protein (hsCRP) Concentration [Baseline, Week 52]

    7. Change from Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% min/hour) [Baseline, Week 52]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Artemis Institute for Clinical Research Riverside California United States 92503
    2 Artemis Institute for Clinical Research San Diego California United States 92103
    3 Teradan Clinical Trials, LLC Brandon Florida United States 33511
    4 Renstar Medical Research Ocala Florida United States 34470
    5 Palm Beach Research Center West Palm Beach Florida United States 33409
    6 NeuroTrials Research Inc Atlanta Georgia United States 30328
    7 Rocky Mountain Clinical Research Idaho Falls Idaho United States 83404
    8 Brengle Family Medicine Indianapolis Indiana United States 46260
    9 Lillestol Research Fargo North Dakota United States 58104
    10 NeuroScience Research Center Canton Ohio United States 44718
    11 CTI-CRC Cincinnati Ohio United States 45212
    12 Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18) Pittsburgh Pennsylvania United States 15236
    13 Preferred Primary Care Physicians Uniontown Pennsylvania United States 15401
    14 FutureSearch Trials of Neurology Austin Texas United States 78731
    15 Gadolin Research Beaumont Texas United States 77702
    16 Advanced Neuro Research Center - ANRC El Paso Texas United States 79912
    17 Epic Medical Research Red Oak Texas United States 75154
    18 Sleep Therapy & Research Center San Antonio Texas United States 78229
    19 Rainier Clinical Research Center Renton Washington United States 98057
    20 Woolcock Institute of Medical Research Sydney New South Wales Australia 2037
    21 Flinders University Bedford Park South Australia Australia 5042
    22 The University of Western Australia - Centre for Sleep Science Crawley Western Australia Australia 6009
    23 Núcleo de Pesquisa Clínica do Rio Grande do Sul Porto Alegre Rio Grande Do Sul Brazil 90430-001
    24 Instituto de Pesquisa clinica de Campinas Campinas São Paulo Brazil 13060-080
    25 CPCLIN Sao Paulo São Paulo Brazil 01228-200
    26 CPQuali Pesquisa Clínica São Paulo Brazil 01228-000
    27 CEPIC - Centro Paulista de Investigação Clínica São Paulo Brazil 04266-010
    28 BR Trials - Ensaios Clinicos e Consultoria São Paulo Brazil 05003-090
    29 Hospital das Clinicas FMUSP São Paulo Brazil 05403-000
    30 Beijing Hospital Beijing Beijing China 100005
    31 The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China 210011
    32 The first hospital of Jilin university Cahngchun Jilin China 130021
    33 Zhongshan Hospital,Fudan University Shanghai Shanghai China 200032
    34 West China Hospital of Sichuan University Cheng Du Sichuan China 610041
    35 Tianjin Medical University General Hospital Tianjin Tianjin China 300052
    36 Wuxi People's Hospital Wuxi China 214003
    37 Vseobecna fakultni nemocnice v Praze Praha 2 Czechia 12808
    38 Praglandia s.r.o Praha 5 Czechia 150 00
    39 Siteworks GmbH Hannover Niedersachsen Germany 30449
    40 InnoDiab Forschung Gmbh Essen Nordrhein-Westfalen Germany 45136
    41 Institut für Diabetesforschung GmbH Münster Münster Nordrhein- Germany 48145
    42 AmBeNet GmbH Leipzig Sachsen Germany 04107
    43 RED-Institut GmbH Oldenburg Schleswig-Holstein Germany 23758
    44 Lungenpraxis Schleswig Schleswig Schleswig-Holstein Germany 24837
    45 Advanced Sleep Research Berlin Germany 10117
    46 Klinik Donaustauf Donaustauf Germany 93093
    47 Diabeteszentrum Hamburg West Hamburg Germany 22607
    48 Koujunkai Daido Clinic Nagoya Aichi Japan 457-8511
    49 Kirigaokatsuda Hospital Kitakyushu Fukuoka Japan 802-0052
    50 RESM Respiratory and Sleep Medical Care Clinic Yokohama Kanagawa Japan 222-0033
    51 Sakai City Medical Center Sakai Osaka Japan 593-8304
    52 Tokyo-Eki Center-building Clinic Chuo-ku Tokyo Japan 103-0027
    53 Fukuwa Clinic Chuo-ku Tokyo Japan 104-0031
    54 Tenyoukai Chuo Clinic Kagoshima Japan 892-0822
    55 AMC Nishiumeda Clinic Osaka Japan 530-0001
    56 Osaka Kaisei Hospital Osaka Japan 532-0003
    57 RM Pharma Specialists Mexico City Distrito Federal Mexico 03100
    58 Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares Mexico City Distrito Federal Mexico 11650
    59 Private Practice - Dr. Arechavaleta Granell Maria del Rosario Guadalajara Jalisco Mexico 44670
    60 Unidad de Investigación Clínica y Atención Médica HEPA Guadalajara Jalisco Mexico 44670
    61 Servicios Integrales Nova de Monterrey S.A. de C.V. San Nicolas de los Garza Nuevo León Mexico 66450
    62 Unidad Médica para la Salud Integral San Nicolás de los Garza Nuevo León Mexico 66465
    63 Investigacion En Salud Y Metabolismo Sc Chihuahua Mexico 31217
    64 Arké SMO S.A de C.V Veracruz Mexico 91910
    65 Puerto Rico Medical Research Center Hato Rey Puerto Rico 00917
    66 China Medical University Hospital Taichung Taiwan 404332
    67 National Cheng-Kung Uni. Hosp. Tainan Taiwan 704

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05412004
    Other Study ID Numbers:
    • 18357
    • I8F-MC-GPIF
    • I8F-MC-GPI1
    • I8F-MC-GPI2
    • 2021-004552-41
    First Posted:
    Jun 9, 2022
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Apnea
    Sleep Apnea Syndromes
    Sleep Apnea, Obstructive
    Obesity
    Tirzepatide

    Study Results

    No Results Posted as of Aug 19, 2022