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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05412004
Recruitment Status : Recruiting
First Posted : June 9, 2022
Last Update Posted : November 28, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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
Sleep Apnea Obesity Drug: Tirzepatide Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 21, 2022
Estimated Primary Completion Date : February 29, 2024
Estimated Study Completion Date : February 29, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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 Name: 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




Primary Outcome Measures :
  1. Percent Change from Baseline in Apnea-Hypopnea Index (AHI) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Week 52 ]
  3. Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 [ Time Frame: Week 52 ]
  4. Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 52 ]
  5. Change from Baseline in Systolic Blood Pressure (SBP) [ Time Frame: Baseline, Week 52 ]
  6. Change from Baseline in High Sensitivity C reactive Protein (hsCRP) Concentration [ Time Frame: Baseline, Week 52 ]
  7. Change from Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% min/hour) [ Time Frame: Baseline, Week 52 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05412004


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CT LILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
Show Show 67 study locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05412004    
Other Study ID Numbers: 18357
I8F-MC-GPIF ( Other Identifier: Eli Lilly and Company )
I8F-MC-GPI1 ( Other Identifier: Eli Lilly and Company )
I8F-MC-GPI2 ( Other Identifier: Eli Lilly and Company )
2021-004552-41 ( EudraCT Number )
First Posted: June 9, 2022    Key Record Dates
Last Update Posted: November 28, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Dyssomnias
Nervous System Diseases
Tirzepatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists