A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee

• Status: Recruiting
• Trial end date: 2026-03-08
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate the safety and efficacy of retatrutide once-weekly in participants who have obesity or are overweight and have osteoarthritis (OA) of the knee. The study will lasts about 77 weeks.

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

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

Inclusion Criteria:

• Have a body mass index (BMI) ≥27 kilogram/kg/m² at screening.

• Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

• 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.

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.

• Have a self-reported or documented change in body weight >5 kg (11 pounds) within 90 days prior to screening.

• Have been taking 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.