Clinical trial NCT05412004: Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obstructive Sleep Apnea
Obesity
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-06-09
Enrollment: 469
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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)

Primary outcomes:
measure: Change From Baseline in Apnea-Hypopnea Index (AHI)
timeFrame: Baseline, Week 52
Secondary outcomes:
measure: Percent Change From Baseline in Apnea-Hypopnea Index (AHI)
timeFrame: Baseline, Week 52
measure: Percentage of Participants With ≥50% AHI Reduction From Baseline
timeFrame: Week 52
measure: Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10
timeFrame: Week 52
measure: Change From Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% Min/Hour)
timeFrame: Baseline, Week 52
measure: 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)
timeFrame: Baseline, Week 52
measure: Percent Change From Baseline in Body Weight
timeFrame: Baseline, Week 52
measure: Change From Baseline in High Sensitivity C Reactive Protein (hsCRP) Concentration
timeFrame: Baseline, Week 52
measure: Change From Baseline in Systolic Blood Pressure (SBP)
timeFrame: Baseline, Week 48
Other outcomes:
Locations:
city: Riverside
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Brandon
country: United States
facility: Teradan Clinical Trials, LLC
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research Inc
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: Indianapolis
country: United States
facility: Brengle Family Medicine
state: Indiana
city: Fargo
country: United States
facility: Lillestol Research
state: North Dakota
city: Canton
country: United States
facility: NeuroScience Research Center
state: Ohio
city: Cincinnati
country: United States
facility: CTI-CRC
state: Ohio
city: Pittsburgh
country: United States
facility: Office 18
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Beaumont
country: United States
facility: Gadolin Research
state: Texas
city: El Paso
country: United States
facility: Advanced Neuro Research Center - ANRC
state: Texas
city: Red Oak
country: United States
facility: Epic Medical Research
state: Texas
city: San Antonio
country: United States
facility: Sleep Therapy Research Center
state: Texas
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Sydney
country: Australia
facility: Woolcock Institute of Medical Research
state: New South Wales
city: Bedford Park
country: Australia
facility: Flinders University
state: South Australia
city: Porto Alegre
country: Brazil
facility: Núcleo de Pesquisa Clínica do Rio Grande do Sul
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: CPCLIN
state: São Paulo
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clínica
city: São Paulo
country: Brazil
facility: Hospital das Clinicas FMUSP
city: São Paulo
country: Brazil
facility: BR Trials - Ensaios Clinicos e Consultoria
city: São Paulo
country: Brazil
facility: Hospital das Clinicas FMUSP
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shanghai
country: China
facility: Zhongshan Hospital,Fudan University
state: Shanghai
city: ChengDu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Praha 5
country: Czechia
facility: Praglandia s.r.o
city: Hannover
country: Germany
facility: Siteworks GmbH
state: Niedersachsen
city: Essen
country: Germany
facility: InnoDiab Forschung Gmbh
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Institut für Diabetesforschung GmbH Münster
state: Nordrhein-Westfalen
city: Oldenburg
country: Germany
facility: RED-Institut GmbH
state: Schleswig-Holstein
city: Schleswig
country: Germany
facility: Lungenpraxis Schleswig
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Advanced Sleep Research
city: Hamburg
country: Germany
facility: Diabeteszentrum Hamburg West
city: Nagoya
country: Japan
facility: Koujunkai Daido Clinic
state: Aichi
city: Kitakyushu
country: Japan
facility: Kirigaokatsuda Hospital
state: Fukuoka
city: Yokohama
country: Japan
facility: RESM Respiratory and Sleep Medical Care Clinic
state: Kanagawa
city: Sakai
country: Japan
facility: Sakai City Medical Center
state: Osaka
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
city: Osaka
country: Japan
facility: Osaka Kaisei Hospital
city: Mexico City
country: Mexico
facility: RM Pharma Specialists
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Private Practice - Dr. Arechavaleta Granell Maria del Rosario
state: Jalisco
city: Guadalajara
country: Mexico
facility: Unidad de Investigación Clínica y Atención Médica HEPA
state: Jalisco
city: San Nicolas de los Garza
country: Mexico
facility: Servicios Integrales Nova de Monterrey S.A. de C.V.
state: Nuevo León
city: San Nicolás de los Garza
country: Mexico
facility: Unidad Médica para la Salud Integral
state: Nuevo León
city: Chihuahua
country: Mexico
facility: Investigacion En Salud Y Metabolismo Sc
city: Veracruz
country: Mexico
facility: Arké SMO S.A de C.V
city: Hato Rey
country: Puerto Rico
facility: Puerto Rico Medical Research Center
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: