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

Obesity Clinical Trial

— SURMOUNT-OSA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05412004
• Other study ID #: 18357
• Secondary ID: I8F-MC-GPIFI8F-M
• Status: Completed
• Phase: Phase 3
• Start date: June 21, 2022
• Est. completion date: March 29, 2024

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 GPI1 and those who are and plan to stay on PAP therapy in GPI2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 469
• Est. completion date: March 29, 2024
• Est. primary completion date: March 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Apnea
• Obesity
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Tirzepatide
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Australia	Flinders University	Bedford Park	South Australia
Australia	Woolcock Institute of Medical Research	Sydney	New South Wales
Brazil	Núcleo de Pesquisa Clínica do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul
Brazil	CPCLIN	Sao Paulo	São Paulo
Brazil	BR Trials - Ensaios Clinicos e Consultoria	São Paulo
Brazil	CPQuali Pesquisa Clínica	São Paulo
Brazil	Hospital das Clinicas FMUSP	São Paulo
Brazil	Hospital das Clinicas FMUSP	São Paulo
China	The First Hospital of Jilin University	Changchun	Jilin
China	West China Hospital, Sichuan University	ChengDu	Sichuan
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Zhongshan Hospital,Fudan University	Shanghai	Shanghai
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Wuxi People's Hospital	Wuxi	Jiangsu
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
Czechia	Praglandia s.r.o	Praha 5
Germany	Advanced Sleep Research	Berlin
Germany	InnoDiab Forschung Gmbh	Essen	Nordrhein-Westfalen
Germany	Diabeteszentrum Hamburg West	Hamburg
Germany	Siteworks GmbH	Hannover	Niedersachsen
Germany	Institut für Diabetesforschung GmbH Münster	Münster	Nordrhein-Westfalen
Germany	RED-Institut GmbH	Oldenburg	Schleswig-Holstein
Germany	Lungenpraxis Schleswig	Schleswig	Schleswig-Holstein
Japan	Fukuwa Clinic	Chuo-ku	Tokyo
Japan	Kirigaokatsuda Hospital	Kitakyushu	Fukuoka
Japan	Koujunkai Daido Clinic	Nagoya	Aichi
Japan	Osaka Kaisei Hospital	Osaka
Japan	Sakai City Medical Center	Sakai	Osaka
Japan	RESM Respiratory and Sleep Medical Care Clinic	Yokohama	Kanagawa
Mexico	Investigacion En Salud Y Metabolismo Sc	Chihuahua
Mexico	Private Practice - Dr. Arechavaleta Granell Maria del Rosario	Guadalajara	Jalisco
Mexico	Unidad de Investigación Clínica y Atención Médica HEPA	Guadalajara	Jalisco
Mexico	Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares	Mexico City	Distrito Federal
Mexico	RM Pharma Specialists	Mexico City	Distrito Federal
Mexico	Servicios Integrales Nova de Monterrey S.A. de C.V.	San Nicolas de los Garza	Nuevo León
Mexico	Unidad Médica para la Salud Integral	San Nicolás de los Garza	Nuevo León
Mexico	Arké SMO S.A de C.V	Veracruz
Puerto Rico	Puerto Rico Medical Research Center	Hato Rey
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
United States	NeuroTrials Research Inc	Atlanta	Georgia
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Gadolin Research	Beaumont	Texas
United States	Teradan Clinical Trials, LLC	Brandon	Florida
United States	NeuroScience Research Center	Canton	Ohio
United States	CTI-CRC	Cincinnati	Ohio
United States	Advanced Neuro Research Center - ANRC	El Paso	Texas
United States	Lillestol Research	Fargo	North Dakota
United States	Rocky Mountain Clinical Research	Idaho Falls	Idaho
United States	Brengle Family Medicine	Indianapolis	Indiana
United States	Renstar Medical Research	Ocala	Florida
United States	Office 18	Pittsburgh	Pennsylvania
United States	Epic Medical Research	Red Oak	Texas
United States	Rainier Clinical Research Center	Renton	Washington
United States	Artemis Institute for Clinical Research	Riverside	California
United States	Sleep Therapy Research Center	San Antonio	Texas
United States	Preferred Primary Care Physicians	Uniontown	Pennsylvania
United States	Palm Beach Research Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Apnea-Hypopnea Index (AHI)		Baseline, Week 52
Secondary	A Hierarchical Combination of Functional Outcomes of Sleep Questionnaire (FOSQ) 10 Score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score	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.	Baseline (Week 0) to Study Completion (Estimated Up to 52 Weeks)
Secondary	Percent Change from Baseline in Apnea-Hypopnea Index (AHI)		Baseline, Week 52
Secondary	Percentage of Participants with =50% AHI Reduction from Baseline		Week 52
Secondary	Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) =10		Week 52
Secondary	Percent Change from Baseline in Body Weight		Baseline, Week 52
Secondary	Change from Baseline in Systolic Blood Pressure (SBP)		Baseline, Week 48
Secondary	Change from Baseline in High Sensitivity C reactive Protein (hsCRP) Concentration		Baseline, Week 52
Secondary	Change from Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% min/hour)		Baseline, Week 52

External Links

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