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

Phase 3

Active, not recruiting

• Conditions: Obesity; Overweight; Osteo Arthritis Knee
• Interventions: Drug: Placebo; Drug: Retatrutide

• Registration Number: NCT05931367
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-07-05
• Study Start: 2023-08-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-22
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 405

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive placebo.
Retatrutide Dose 1	Retatrutide	Participants will receive retatrutide subcutaneously (SC).
Retatrutide Dose 2	Retatrutide	Participants will receive retatrutide SC.

Primary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Body Weight	Baseline, Week 68
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score	Baseline, Week 68

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Systolic Blood Pressure (SBP)	Baseline, Week 68
Change from Baseline in Diastolic Blood Pressure (DBP)	Baseline, Week 68
Percent Change from Baseline in Fasting Insulin	Baseline, Week 68
Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score	Baseline, Week 68
Change from Baseline in Average Pain Intensity Numeric Rating Score (API-NRS) Score	Baseline, Week 68
Change from Baseline in Worst Pain Intensity Numeric Rating Score (WPI-NRS) Score	Baseline, Week 68
Percent Change from Baseline in Triglycerides	Baseline, Week 68
Change from Baseline in Body Mass Index (BMI)	Baseline, Week 68
Percent Change from Baseline in Total Cholesterol	Baseline, Week 68
Change from Baseline in Waist Circumference	Baseline, Week 68
Change from Baseline in the WOMAC Physical Function Subscale Score	Baseline, Week 68

Trial Locations

Locations (47)

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

Artemis Institute for Clinical Research; 🇺🇸 San Diego, California, United States

Chase Medical Research, LLC; 🇺🇸 Waterbury, Connecticut, United States

Suncoast Research Group; 🇺🇸 Miami, Florida, United States

North Georgia Clinical Research; 🇺🇸 Woodstock, Georgia, United States

Elite Clinical Trials; 🇺🇸 Blackfoot, Idaho, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

MedVadis Research Corporation; 🇺🇸 Waltham, Massachusetts, United States

Great Lakes Research Group, Inc.; 🇺🇸 Bay City, Michigan, United States

Clinvest Research LLC; 🇺🇸 Springfield, Missouri, United States

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