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

Completed · Phase 3 · Has a placebo group

Conditions studied: Obstructive Sleep Apnea, Obesity

In brief

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.

Key facts

Study ID

NCT05412004

Run by

Eli Lilly and Company

People needed

469

Starts

2022-06-21

Expected to finish

2024-03-29

Last updated by the study team

2025-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Teradan Clinical Trials, LLC — Brandon, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• NeuroTrials Research Inc — Atlanta, Georgia, United States
• Rocky Mountain Clinical Research — Idaho Falls, Idaho, United States
• Brengle Family Medicine — Indianapolis, Indiana, United States
• Lillestol Research — Fargo, North Dakota, United States
• NeuroScience Research Center — Canton, Ohio, United States
• CTI-CRC — Cincinnati, Ohio, United States
• Office 18 — Pittsburgh, Pennsylvania, United States
• Preferred Primary Care Physicians — Uniontown, Pennsylvania, United States
• FutureSearch Trials of Neurology — Austin, Texas, United States
• Gadolin Research — Beaumont, Texas, United States
• Advanced Neuro Research Center - ANRC — El Paso, Texas, United States
• Epic Medical Research — Red Oak, Texas, United States
• Sleep Therapy Research Center — San Antonio, Texas, United States
• Rainier Clinical Research Center — Renton, Washington, United States
• Woolcock Institute of Medical Research — Sydney, New South Wales, Australia
• Flinders University — Bedford Park, South Australia, Australia
• Núcleo de Pesquisa Clínica do Rio Grande do Sul — Porto Alegre, Rio Grande do Sul, Brazil
• CPCLIN — São Paulo, São Paulo, Brazil
• CPQuali Pesquisa Clínica — São Paulo, Brazil
• Hospital das Clinicas FMUSP — São Paulo, Brazil
• BR Trials - Ensaios Clinicos e Consultoria — São Paulo, Brazil
• Artemis Institute for Clinical Research — Riverside, California, United States

Full record on ClinicalTrials.gov

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