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Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight

RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Osteoarthritis, Overweight or Obesity

Interventions: Eloralintide, Placebo

Countries: United States, Argentina, Belgium, Brazil, Canada, China, Czechia, Denmark

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 (liposuction, cryolipolysis, or abdominoplasty allowed if performed greater than 1 year before screening)
* Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)
* Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
* Have an active knee infection
* Have had within 90 days prior to screening:

  * heart attack
  * stroke
  * coronary artery revascularization
  * unstable angina, or
  * hospitalization due to congestive heart failure
* Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure
* Have taken medications or alternative remedies intended for weight loss within 90 days of screening

Locations (152)

Mobile, Alabama, United States
Mesa, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Fountain Valley, California, United States
Santa Ana, California, United States
Spring Valley, California, United States
Walnut Creek, California, United States
Colorado Springs, Colorado, United States
Jacksonville, Florida, United States
St. Petersburg, Florida, United States
Winter Park, Florida, United States
Decatur, Georgia, United States
Ammon, Idaho, United States
Chicago, Illinois, United States
Evansville, Indiana, United States
Newton, Kansas, United States
Louisville, Kentucky, United States
Burlington, Massachusetts, United States
Quincy, Massachusetts, United States
Brooklyn, New York, United States
Buffalo, New York, United States
Long Island City, New York, United States
Rochester, New York, United States
Tulsa, Oklahoma, United States
Plymouth Meeting, Pennsylvania, United States
Bellaire, Texas, United States
DeSoto, Texas, United States
Fort Worth, Texas, United States
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