Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight (ENLIGHTEN-4)

Lilly

Status and phase: Not yet enrolling; Phase 3

Conditions: Overweight or Obesity; Osteoarthritis

Treatments: Drug: Placebo; Drug: Eloralintide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07353931

J3R-MC-YDAN (Other Identifier)

J3R-MC-YOA2 (Other Identifier)

2025-523768-19-00 (EU Trial (CTIS) Number)

27761

J3R-MC-YOA1 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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900 participants in 4 patient groups, including a placebo group

Eloralintide (YOA1)

Experimental group

Description:

Participants will receive eloralintide subcutaneously (SC)

Treatment:

Drug: Eloralintide

Placebo (YOA1)

Placebo Comparator group

Description:

Participants will receive placebo SC

Treatment:

Drug: Placebo

Eloralintide (YOA2)

Experimental group

Description:

Participants will receive eloralintide SC

Treatment:

Drug: Eloralintide

Placebo (YOA2)

Placebo Comparator group

Description:

Participants will receive placebo SC

Treatment:

Drug: Placebo