A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight
- Conditions
- Obstructive Sleep ApneaOverweightObesityType 2 Diabetes
- Interventions
- Drug: Placebo
- Registration Number
- NCT05929079
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of this study is to is to evaluate the efficacy and safety of retatrutide in participants with type 2 diabetes in participants who have obesity or overweight (J1I-MC-GZBK master protocol) including a subset of participants who have obstructive sleep apnea (OSA) (J1I-MC-GSA2). The study will last about 89 weeks and will include up to 24 visits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- Have a body mass index (BMI) greater than or equal to 27.0 kilogram/square meter (kg/m ²)
- Have Type 2 Diabetes (T2D)
- Are on stable treatment for T2D for at least 90 days
- Have a history of at least one unsuccessful dietary effort to lose body weight.
GSA2 Inclusion Criteria
- Previously diagnosed with OSA
- Have AHI ≥15 on polysomnography at screening (definition of moderate-to-severe OSA)
- For participants not on positive airway pressure (PAP) therapy: unable or unwilling to use PAP therapy and have not used PAP for at least 4 weeks prior to screening.
- If on PAP therapy, have been on PAP therapy for at least 3 consecutive months prior to screening, and willing to temporarily stop using PAP therapy for approximately 7 days prior to each of the sleep study (PSG) visits.
- Have a self-reported or documented change in body weight >5 kg (11 pounds) within 90 days.
- Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
- Have a prior or planned surgical treatment for obesity.
- Have Type 1 diabetes
- Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- Have had pancreatitis
GSA2 Exclusion Criteria
- Use stimulants (for example, modafinil, armodafinil, solriamfetol, pitolisant, amphetamine) less than 3 months prior to screening.
- Use hypnotics, mirtazapine, opioids, trazodone, and zonisamide less than 3 months prior to screening.
- Use a dental appliance or other device to treat OSA other than PAP therapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Retatrutide Dose 3 Retatrutide Participants will receive retatrutide SC. Retatrutide Dose 2 Retatrutide Participants will receive retatrutide SC. Retatrutide Dose 1 Retatrutide Participants will receive retatrutide subcutaneously (SC). Placebo Placebo Participants will receive placebo.
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight Baseline, Week 80 Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset Baseline, Week 80
- Secondary Outcome Measures
Name Time Method Change from Baseline in Hemoglobin (A1c) HbA1c % Baseline, Week 80 Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score Baseline, Week 80 Change from Baseline in Diastolic Blood Pressure (DBP) Baseline, Week 80 Change from Baseline in Body Mass Index (BMI) Baseline, Week 80 Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) Baseline through Week 80 AUC is presented as a single average measure of AUC across the study duration.
Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA2 Subset Week 80 Percent Change from Baseline in Total Cholesterol Baseline, Week 80 Percent Change from Baseline in Triglycerides Baseline, Week 80 Percent Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset Baseline, Week 80 Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA2 Subset Baseline to Week 80 Change from Baseline in Waist Circumference Baseline, Week 80 Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 80 Change from Baseline in Fasting Glucose Baseline, Week 80 A Hierarchical Combination of Functional Outcomes of Sleep Questionnaire (FOSQ) 10 score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score for GSA2 Subset Baseline to Week 80 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 component.
Trial Locations
- Locations (97)
Centrul Medical Mediab
🇷🇴Târgu-Mureș, Mureș, Romania
Arké SMO S.A de C.V
🇲🇽Veracruz, Mexico
Geea Medical Easy Diet
🇷🇴Bucharest, București, Romania
Centrul Medical NutriLife
🇷🇴Bucharest, București, Romania
Gama Diamed
🇷🇴Mangalia, Constanța, Romania
Core Research Group
🇦🇺Brisbane, Queensland, Australia
Avron Hospitals
🇮🇳Ahmedabad, Gujarat, India
Diabdana
🇷🇴Oradea, Bihor, Romania
CMI Dr.Pletea Noemi SRL
🇷🇴Bacău, Romania
Centro Periférico de Especialidades Bola Azul
🇪🇸Almeria, Almería, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Andalucía, Spain
H.R.U Málaga - Hospital Civil
🇪🇸Málaga, Andalucía, Spain
Pinnacle Research Group, LLC
🇺🇸Anniston, Alabama, United States
Cullman Clinical Trials
🇺🇸Cullman, Alabama, United States
Preferred Research Partners
🇺🇸Little Rock, Arkansas, United States
Core Healthcare Group
🇺🇸Cerritos, California, United States
Velocity Clinical Research, Westlake
🇺🇸Los Angeles, California, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Excel Medical Clinical Trials
🇺🇸Boca Raton, Florida, United States
Teradan Clinical Trials, LLC
🇺🇸Brandon, Florida, United States
Fleming Island Center for Clinical Research
🇺🇸Fleming Island, Florida, United States
Therafirst Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Quantum Clinical Trials
🇺🇸Miami Beach, Florida, United States
Clinical Site Partners LLC, dba Flourish Research
🇺🇸Miami, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Clinical Research Center of Florida
🇺🇸Pompano Beach, Florida, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Clinical Site Partners, LLC dba Flourish Research
🇺🇸Winter Park, Florida, United States
NeuroTrials Research Inc
🇺🇸Atlanta, Georgia, United States
Centricity Research Rincon Pulmonology
🇺🇸Rincon, Georgia, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Brengle Family Medicine
🇺🇸Indianapolis, Indiana, United States
MedVadis Research Corporation
🇺🇸Waltham, Massachusetts, United States
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
Las Vegas Medical Research
🇺🇸Las Vegas, Nevada, United States
Mid Hudson Medical Research
🇺🇸New Windsor, New York, United States
Monroe Biomedical Research
🇺🇸Monroe, North Carolina, United States
Carteret Medical Group
🇺🇸Morehead City, North Carolina, United States
Lillestol Research
🇺🇸Fargo, North Dakota, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Intrepid Research
🇺🇸Cincinnati, Ohio, United States
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
🇺🇸Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians
🇺🇸Uniontown, Pennsylvania, United States
Tribe Clinical Research, LLC
🇺🇸Greenville, South Carolina, United States
Trial Management Associates
🇺🇸Myrtle Beach, South Carolina, United States
Tribe Clinical Research - Spartanburg
🇺🇸Spartanburg, South Carolina, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
Velocity Clinical Research, Dallas
🇺🇸Dallas, Texas, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Centro Médico Viamonte
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Consultorio de Investigación Clínica EMO SRL
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro de Salud e Investigaciones Médicas
🇦🇷Santa Rosa, La Pampa, Argentina
Emeritus Research
🇦🇺Camberwell, Victoria, Australia
Woolcock Institute of Medical Research
🇦🇺Macquarie Park, New South Wales, Australia
The AIM Centre / Hunter Diabetes Centre
🇦🇺Merewether, New South Wales, Australia
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Queensland, Australia
Nightingale Research
🇦🇺Adelaide, South Australia, Australia
Flinders University
🇦🇺Bedford Park, South Australia, Australia
Southern Adelaide Diabetes & Endocrine Services
🇦🇺Oaklands Park, South Australia, Australia
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Austin Health - Repatriation Hospital
🇦🇺Heidelberg West, Victoria, Australia
Advara HeartCare Joondalup
🇦🇺Joondalup, Western Australia, Australia
BR Trials - Ensaios Clinicos e Consultoria
🇧🇷Sao Paulo, São Paulo, Brazil
CPQuali Pesquisa Clínica
🇧🇷São Paulo, Brazil
CEPIC - Centro Paulista de Investigação Clínica
🇧🇷São Paulo, Brazil
All India Institute of Medical Sciences
🇮🇳Raipur, Chhattisgarh, India
V.S. General Hospital
🇮🇳Ahmedabad, Gujarat, India
Zydus Hospitals & Healthcare Research Pvt.Ltd.
🇮🇳Ahmedabad, Gujarat, India
Life Care Hospital and Research Centre
🇮🇳Bangalore, Karnataka, India
CARE CHL-Hospitals
🇮🇳Indore, Madhya Pradesh, India
Sawai Man Singh Medical College Hospital (SMS Hospital)
🇮🇳Jaipur, Rajasthan, India
Sushruta Multispeciality Hospital & Research Centre
🇮🇳Hubli, Karnataka, India
Mysore Medical College
🇮🇳Mysore, Karnataka, India
Madras Diabetes Research Foundation
🇮🇳Chennai, Tamil Nadu, India
Christian Medical College Vellore
🇮🇳Vellore, Tamil Nadu, India
Diabetes Research Center
🇮🇳Hyderabad, Telangana, India
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
🇮🇳Kolkata, West Bengal, India
Centro de Investigacion en Artritis y Osteoporosis SC
🇲🇽Mexicali, Baja California, Mexico
RM Pharma Specialists
🇲🇽Mexico City, Distrito Federal, Mexico
Clinica Omega
🇲🇽Mexico City, Distrito Federal, Mexico
Care Hospitals Hyderabad- Banjara Hills
🇮🇳Hyderabad, Telangana, India
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
🇲🇽Mexico City, Distrito Federal, Mexico
Diseno y Planeacion en Investigacion Medica
🇲🇽Guadalajara, Jalisco, Mexico
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
🇲🇽Guadalajara, Jalisco, Mexico
Unidad de Investigación Clínica y Atención Médica HEPA
🇲🇽Guadalajara, Jalisco, Mexico
Cardiolink Clin Trials
🇲🇽Monterrey, Nuevo León, Mexico
Unidad biomedica avanzada monterrey
🇲🇽Monterrey, Nuevo León, Mexico
Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
🇲🇽Chihuahua, Mexico
FAICIC S. de R.L. de C.V.
🇲🇽Veracruz, Mexico
Complejo Asistencial Universitario de León - Hospital de León
🇪🇸León, Castilla Y León, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Madrid, Comunidad De, Spain
Vithas Hospital Sevilla
🇪🇸Seville, Sevilla, Spain
Hospital Universitario Virgen Del Rocio
🇪🇸Sevilla, Spain