A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Osteoarthritis Knee Pain, and Obesity or Overweight (ENLIGHTEN-4)
Eli Lilly and Company
Summary
The YDAN master protocol will support two independent studies, J3R-MC-YOA1 and J3R-MC-YOA2. Each study will investigate how well and safely Eloralintide (LY3841136) works in adults with obesity or overweight who have osteoarthritis (OA) of the knee with pain. Participation in the study will last about 75 weeks, including screening.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Have a body mass index (BMI) of 27 kilograms per square meter (kg/m²) or higher at screening * Have a stable body weight (less than 5% body weight change) for 90 days prior to screening * Have tried at least once to lose weight through diet but were unsuccessful * Have osteoarthritis of the knee and at least one of the following conditions: * Be over 50 years old * Have morning knee stiffness that lasts about 30 minutes * Have a crackling or grinding sound or feeling in the knee Exclusion Criteria: * Have a prior or planned surgical treatment for obesity (liposu…
Interventions
- DrugEloralintide
Administered SC
- DrugPlacebo
Placebo administered SC
Locations (154)
- AMR ClinicalMobile, Alabama
- Care Access - 801 South Power Road, MesaMesa, Arizona
- Elite Pain and Spine Institute - South Crimson RoadMesa, Arizona
- Tucson Orthopaedic Institute - North Wyatt DriveTucson, Arizona
- Ark Clinical Research - Fountain ValleyFountain Valley, California
- Wolverine Clinical TrialsSanta Ana, California