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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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 (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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Eloralintide (YOA1) 		Participants will receive eloralintide subcutaneously (SC)
  • Drug: Eloralintide
    Administered SC
    Other names:
    • LY3841136
Placebo Comparator
Placebo (YOA1) 		Participants will receive placebo SC
  • Drug: Placebo
    Placebo administered SC
Experimental
Eloralintide (YOA2) 		Participants will receive eloralintide SC
  • Drug: Eloralintide
    Administered SC
    Other names:
    • LY3841136
Placebo Comparator
Placebo (YOA2) 		Participants will receive placebo SC
  • Drug: Placebo
    Placebo administered SC

Recruiting Locations

AMR Clinical
Mobile 4076598, Alabama 4829764 36608
Contact:
251-414-1984

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.