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

• Status: Recruiting
• Trial end date: 2026-05-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

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 OS)

• 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 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.