DRUG
Retatrutide
Administered SC
Status
Completed
Phase
Phase 3
Enrollment
2,335
Locations
134
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
Administered SC
DRUG
Administered SC
Timeline
First posted
Jul 3, 2023
Study start
Jul 10, 2023
Primary completion
Apr 6, 2026
Study completion
Apr 30, 2026
Results posted
Not reported
Registry updated
Jun 3, 2026
Outcomes
Percent Change From Baseline in Body Weight
Time frame · Baseline, Week 80
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score for GOA1 Subset
Time frame · Baseline, Week 80
Change from Baseline in Apnea-Hypopnea Index (AHI) Events Per Hour for GSA1 Subset
Time frame · Baseline, Week 80
Percent Change from Baseline in Body Weight to
Time frame · Baseline, Week 104
Change from Baseline in Body Mass Index (BMI)
Time frame · Baseline, Week 80
Change from Baseline in Waist Circumference
Time frame · Baseline, Week 80
Change from Baseline in Systolic Blood Pressure (SBP)
Time frame · Baseline, Week 80
Percent Change form Baseline in Fasting Insulin
Time frame · Baseline, Week 80
Change from Baseline in HbA1c
Time frame · Baseline, Week 80
Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
Time frame · Baseline, Week 80
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)
Time frame · Baseline through Week 80
AUC is presented as a single average measure of AUC across the study duration.
Change from Baseline in the WOMAC Physical Function Subscale Score for GOA1 Subset
Time frame · Baseline, Week 80
Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score for GOA1 Subset
Time frame · Baseline, Week 80
Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score for GOA1 Subset
Time frame · Baseline, Week 80
Eligibility
Inclusion Criteria: * 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. Exclusion Criteria: * 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 locations
Australia · Brazil · Canada · Hungary · India · Mexico · Poland · Puerto Rico · Romania · Spain · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Central Phoenix Medical Clinic
Phoenix, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Medical Investigations
Little Rock, Arkansas, United States
Neuro-Pain Medical Center
Fresno, California, United States
Valley Research
Fresno, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 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
Clinical Neuroscience Solutions
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
NeuroTrials Research Inc
Atlanta, Georgia, 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
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, United States
MedVadis Research Corporation
Waltham, Massachusetts, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
StudyMetrix Research
City of Saint Peters, Missouri, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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