A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes, Obesity, Overweight, Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT05929079

Run by

Eli Lilly and Company

People needed

1152

Starts

2023-07-11

Expected to finish

2026-06-16

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Las Vegas Medical Research — Las Vegas, Nevada, United States
• Pinnacle Research Group, LLC — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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