DRUG
Retatrutide
Administered SC
Status
Completed
Phase
Phase 3
Enrollment
1,152
Locations
98
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
Administered SC
DRUG
Administered SC
Timeline
First posted
Jul 3, 2023
Study start
Jul 11, 2023
Primary completion
Jun 16, 2026
Study completion
Jun 16, 2026
Results posted
Not reported
Registry updated
Jul 30, 2026
Outcomes
Percent Change from Baseline in Body Weight
Time frame · Baseline, Week 80
Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset
Time frame · Baseline, Week 80
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
Change from Baseline in Diastolic Blood Pressure (DBP)
Time frame · Baseline, Week 80
Percent Change from Baseline in Total Cholesterol
Time frame · Baseline, Week 80
Percent Change from Baseline in Triglycerides
Time frame · Baseline, Week 80
Change from Baseline in Hemoglobin (A1c) 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
Change from Baseline in Fasting Glucose
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.
Eligibility
Inclusion Criteria: * 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. 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 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 locations
Argentina · Australia · Brazil · India · Mexico · Romania · Spain · United States. Showing up to 24 locations stored in the fast local snapshot.
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
Clinical Site Partners LLC, dba Flourish Research
Miami, Florida, United States
Quantum Clinical Trials
Miami Beach, 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
City of Saint Peters, Missouri, United States
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
Eli Lilly · Obesity · Cardiovascular Diseases
Phase 3
Completed
1,946
2026-07
Eli Lilly · Obesity · Overweight
Phase 3
Active, not recruiting
586
2026-07
Eli Lilly · Type 2 Diabetes
Phase 3
Active, not recruiting
320
2026-07
Eli Lilly · Atherosclerotic Cardiovascular Disease (ASCVD) · Chronic Kidney Disease (CKD)
Phase 3
Active, not recruiting
10,000
2026-07
Eli Lilly · Obesity
Phase 3
Active, not recruiting
800
2026-07
Eli Lilly · Metabolic Dysfunction-Associated Steatotic Liver Disease
Phase 3
Recruiting
4,500
2026-07
Eli Lilly · Diabetes Mellitus · Insulin Sensitivity
Phase 1
Active, not recruiting
95
2026-07
Eli Lilly · Type 2 Diabetes Mellitus
Phase 1
Completed
80
2026-06
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.