A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight

Completed · Phase 3 · Has a placebo group

Conditions studied: Obesity, Overweight, Osteoarthritis, Knee, Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT05929066

Run by

Eli Lilly and Company

People needed

2335

Starts

2023-07-10

Expected to finish

2026-04-30

Last updated by the study team

2026-06-03

Who can join

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

You may qualify if…

• 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.

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 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.

Where it is running

• 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
• Clinvest Research LLC — Springfield, Missouri, United States
• Central Phoenix Medical Clinic — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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