A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight
- Conditions
- ObesityOverweightOsteoarthritis, KneeObstructive Sleep Apnea
- Interventions
- Drug: Placebo
- Registration Number
- NCT05929066
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits. Addendum (2) is optional and available to approximately 500 participants to continue treatment with retatrutide for up to an additional 24 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2300
-
Have body mass index (BMI) ≥30.0 kilograms per square meter (kg/m²), or ≥27.0 kg/m² with at least one of the following:
- hypertension
- dyslipidemia
- obstructive sleep apnea, or
- cardiovascular disease
-
History of of at least one unsuccessful dietary effort to reduce body weight
GOA1 Inclusion Criteria:
- Have index knee pain for >12 weeks prior to screening, and presence of index knee pain for >15 days over the previous month
- Have knee X-ray with moderate radiographic changes (Kellgren-Lawrence Grade 2 or 3) per central reading at screening
- Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA.
GSA1 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.
GZBJ Addenda (2) inclusion criteria:
- Have completed the final treatment visit of GZBJ Week 80.
- 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 diabetes mellitus.
- Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- Have had pancreatitis.
GOA1 exclusion criteria
- Have had steroid joint injections within 90 days of screening.
- Have had other joint injections and procedures within 6 months of screening.
- Have joint disease other than osteoarthritis.
GSA1 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.
GZBJ Addenda (2) exclusion criteria
- Have had study intervention discontinuation.
- Have had permanent dose reduction.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Retatrutide Dose 3 Retatrutide Participants will receive retatrutide SC. Retatrutide Extension Period Retatrutide Participants will receive retatrutide after the placebo-controlled 80 week treatment period for an additional 24 weeks. 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 the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score for GOA1 Subset Baseline, Week 80 Change from Baseline in Apnea-Hypopnea Index (AHI) Events Per Hour for GSA1 Subset Baseline, Week 80 Percent Change from Baseline in Body Weight to Baseline, Week 104
- Secondary Outcome Measures
Name Time Method Change from Baseline in HbA1c Baseline, Week 80 Change from Baseline in Body Mass Index (BMI) Baseline, Week 80 Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score for GOA1 Subset Baseline, Week 80 Percent Change from Baseline in AHI for GSA1 Subset Baseline, Week 80 Percent Change form Baseline in Fasting Insulin 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 Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score for GOA1 Subset Baseline, Week 80 Change from Baseline in Waist Circumference Baseline, Week 80 Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 80 Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA1 Subset Baseline to 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.
A Hierarchical Combination of Functional Outcomes of Sleep Questionnaire (FOSQ) 10 Score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score for GSA1 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 components.
Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA1 Subset Week 80 Change from Baseline in the WOMAC Physical Function Subscale Score for GOA1 Subset Baseline, Week 80
Trial Locations
- Locations (133)
Regia Med Kft
🇭🇺Szekesfehervar, Fejér, Hungary
Kohler and Milstein Research S.A. de C.V.
🇲🇽Mérida, Yucatán, Mexico
Centro de Atención e Investigación Clínica
🇲🇽Aguascalientes, Mexico
Central Phoenix Medical Clinic
🇺🇸Phoenix, Arizona, United States
Medifarma 98 Kft
🇭🇺Nyiregyhaza, Nyíregyháza, Hungary
DRC Gyógyszervizsgáló Központ
🇭🇺Balatonfüred, Veszprém, Hungary
Óbudai Egészségügyi Centrum
🇭🇺Budapest, Hungary
ClinDiab Kft.
🇭🇺Budapest, Hungary
EME RED Hospitalaria
🇲🇽Mérida, Yucatán, Mexico
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Neuro-Pain Medical Center
🇺🇸Fresno, California, United States
Medical Investigations
🇺🇸Little Rock, Arkansas, United States
Valley Research
🇺🇸Fresno, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Teradan Clinical Trials, LLC
🇺🇸Brandon, Florida, United States
Suncoast Research Group
🇺🇸Miami, Florida, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
NeuroTrials Research Inc
🇺🇸Atlanta, Georgia, United States
Clinical Neuroscience Solutions
🇺🇸Orlando, Florida, United States
North Georgia Clinical Research
🇺🇸Woodstock, Georgia, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
Brengle Family Medicine
🇺🇸Indianapolis, Indiana, United States
MedVadis Research Corporation
🇺🇸Waltham, Massachusetts, United States
Great Lakes Research Group, Inc.
🇺🇸Bay City, Michigan, United States
Cotton O'Neil Diabetes & Endocrinology
🇺🇸Topeka, Kansas, United States
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
Clinvest Research LLC
🇺🇸Springfield, Missouri, United States
Rochester Clinical Research, LLC
🇺🇸Rochester, New York, United States
Carteret Medical Group
🇺🇸Morehead City, North Carolina, United States
Trial Management Associates - Wilmington - Floral Parkway
🇺🇸Wilmington, North Carolina, United States
Palm Research Center Tenaya
🇺🇸Las Vegas, Nevada, United States
Altoona Center For Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Lillestol Research
🇺🇸Fargo, North Dakota, United States
C.I.C. Mauricie inc.
🇨🇦Trois-Rivières, Quebec, Canada
Tribe Clinical Research, LLC
🇺🇸Greenville, South Carolina, United States
Vanderbilt Health One Hundred Oaks
🇺🇸Nashville, Tennessee, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
Tribe Clinical Research - Spartanburg
🇺🇸Spartanburg, South Carolina, United States
Juno Research
🇺🇸Houston, Texas, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
Emeritus Research
🇦🇺Camberwell, Victoria, Australia
Logan Hospital
🇦🇺Meadowbrook, Queensland, Australia
Fusion Clinical Research
🇦🇺Adelaide, South Australia, Australia
The AIM Centre / Hunter Diabetes Centre
🇦🇺Merewether, New South Wales, Australia
Barwon Health
🇦🇺Geelong, Victoria, Australia
One Clinical Research
🇦🇺Nedlands, Western Australia, Australia
Nightingale Research
🇦🇺Adelaide, South Aust, Australia
CPCLIN
🇧🇷Sao Paulo, São Paulo, Brazil
CPQuali Pesquisa Clínica
🇧🇷São Paulo, Brazil
CEPIC - Centro Paulista de Investigação Clínica
🇧🇷São Paulo, Brazil
Aggarwal and Associates Limited
🇨🇦Brampton, Ontario, Canada
Dr. Steven V. Zizzo Medicine Professional Corporation
🇨🇦Hamilton, Ontario, Canada
Wharton Medical Clinic
🇨🇦Hamilton, Ontario, Canada
Your Research Network
🇨🇦Niagara Falls, Ontario, Canada
Bluewater Clinical Research Group Inc.
🇨🇦Sarnia, Ontario, Canada
Canadian Phase Onward
🇨🇦Toronto, Ontario, Canada
Centre de Recherche Clinique de Laval
🇨🇦Laval, Quebec, Canada
Clinique de médecine Urbaine du Quartier Latin
🇨🇦Montreal, Quebec, Canada
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
🇭🇺Szeged, Csongrád, Hungary
Debreceni Egyetem Klinikai Központ
🇭🇺Debrecen, Hungary
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hungary
Endolife Speciality Hospitals
🇮🇳Guntur, Andhra Pradesh, India
Karnataka Institute of Medical Sciences
🇮🇳Hubli, Karnataka, India
Avron Hospitals
🇮🇳Ahmedabad, Gujarat, India
Surat Institute of Digestive Sciences Hospitals
🇮🇳Surat, Gujarat, India
Indian Institute of Diabetes
🇮🇳Thiruvananthapuram, Kerala, India
Jothydev's Diabetes and Research Center
🇮🇳Trivandrum, Kerala, India
Wockhardt Hospital - Mumbai Central
🇮🇳Mumbai, Maharashtra, India
Chellaram Diabetes Institute
🇮🇳Pune, Maharashtra, India
Deenanath Mangeshkar Hospital & Research Centre
🇮🇳Pune, Maharashtra, India
Lifepoint Multispeciality Hospital
🇮🇳Pune, Maharashtra, India
All India Institute of Medical Sciences
🇮🇳Bhubaneswar, Odisha, India
ILS Hospitals
🇮🇳Kolkata, West Benga, India
Eternal Heart Care Center and Research Institute
🇮🇳Jaipur, Rajasthan, India
Centro de Investigacion en Artritis y Osteoporosis SC
🇲🇽Mexicali, Baja California, Mexico
Christian Medical College Vellore
🇮🇳Vellore, Tamil Nadu, India
RM Pharma Specialists
🇲🇽Mexico City, Distrito Federal, Mexico
Clinica Omega
🇲🇽Mexico City, Distrito Federal, Mexico
Diseno y Planeacion en Investigacion Medica
🇲🇽Guadalajara, Jalisco, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C.
🇲🇽Guadalajara, Jalisco, Mexico
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
🇲🇽Guadalajara, Jalisco, Mexico
Instituto de Diabetes, Obesidad y Nutricion
🇲🇽Cuernavaca, Morelos, Mexico
Unidad de Investigación Clínica y Atención Médica HEPA
🇲🇽Guadalajara, Jalisco, Mexico
Unidad biomedica avanzada monterrey
🇲🇽Monterrey, Nuevo León, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
🇲🇽Monterrey, Nuevo León, Mexico
Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
🇲🇽Chihuahua, Mexico
Arké SMO S.A de C.V
🇲🇽Veracruz, Mexico
INTERCOR
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
CenterMed Lublin NZOZ
🇵🇱Lublin, Lubelskie, Poland
MICS Centrum Medyczne Warszawa
🇵🇱Warszawa, Mazowieckie, Poland
Private Practice - Dr. Robert Witek
🇵🇱Tarnów, Małopolskie, Poland
Uniwersytecki Szpital Kliniczny w Białymstoku
🇵🇱Białystok, Podlaskie, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
🇵🇱Gdansk, Pomorskie, Poland
Centrum Kliniczno-Badawcze
🇵🇱Elblag, Warmińsko-mazurskie, Poland
Ambulatorium Sp. z o.o.
🇵🇱Elbląg, Warmińsko-mazurskie, Poland
Gabinety TERPA
🇵🇱Lublin, Lubelskie, Poland
Centrum Zdrowia Metabolicznego Pawel Bogdanski
🇵🇱Poznań, Wielkopolskie, Poland
NZOZ Salvia CM
🇵🇱Katowice, Śląskie, Poland
Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otylosci
🇵🇱Kielce, Świętokrzyskie, Poland
Ponce Medical School Foundation Inc.
🇵🇷Ponce, Puerto Rico
Diabdana
🇷🇴Oradea, Bihor, Romania
Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului
🇷🇴Bucharest, București, Romania
C.M.D.T.A. Neomed
🇷🇴Brasov, Brașov, Romania
Gama Diamed
🇷🇴Mangalia, Constanța, Romania
Cabinet Medical Dr.Geru
🇷🇴Timisoara, Timiș, Romania
SC Minimed SRL
🇷🇴Bacău, Romania
Diamed Obesity
🇷🇴Galați, Romania
Centrul Medical Consultmed
🇷🇴Iași, Romania
Clinica Korall
🇷🇴Satu Mare, Romania
Policlinica Astra Sibiu
🇷🇴Sibiu, Romania
CHUAC-Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, A Coruña [La Coruña], Spain
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
🇪🇸Ferrol, A Coruña [La Coruña], Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Valenciana, Comunitat, Spain
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
🇪🇸Sevilla, Spain
Leicester General Hospital
🇬🇧Leicester, Leicestershire, United Kingdom
Panthera Biopartners - North London
🇬🇧Enfield, London, City Of, United Kingdom
Rowden Surgery
🇬🇧Chippenham, England, United Kingdom
Layton Medical Centre
🇬🇧Blackpool, Lancashire, United Kingdom
Glasgow Royal Infirmary
🇬🇧Glasgow, Scotland, United Kingdom
Aintree University Hospital NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
Heartlands Hospital
🇬🇧Birmingham, United Kingdom
St Clare Medical Centre
🇬🇧Penzance, United Kingdom
Panthera Biopartners - Sheffield
🇬🇧Sheffield, United Kingdom