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

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

  • Osteoarthritis
  • Overweight or Obesity

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, Alabama 36608
Contact:
251-414-1984

Care Access - 801 South Power Road, Mesa
Mesa, Arizona 85206
Contact:
480-801-9260

Elite Pain and Spine Institute - South Crimson Road
Mesa, Arizona 85209

Tucson Orthopaedic Institute - North Wyatt Drive
Tucson, Arizona 85712
Contact:
520-404-0276

Ark Clinical Research - Fountain Valley
Fountain Valley, California 92708
Contact:
714-988-2021

Wolverine Clinical Trials
Santa Ana, California 92706
Contact:
714-617-2426

Encompass Clinical Research
Spring Valley, California 91978
Contact:
619-660-9068

Diablo Clinical Research, Inc.
Walnut Creek, California 94598
Contact:
925-930-7267

Westside Center for Clinical Research
Jacksonville, Florida 32205
Contact:
904-693-1490

Care Access - St. Petersburg
St. Petersburg, Florida 33710
Contact:
877-791-0656

Conquest Research
Winter Park, Florida 32789
Contact:
407-916-0060

Orita Clinical Research
Decatur, Georgia 30034

Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois 60640
Contact:
773-275-3500

Qualmedica Research, LLC
Evansville, Indiana 47715
Contact:
812-205-2475

AMR Clinical
Newton, Kansas 67114
Contact:
316-804-7304

L-MARC Research Center
Louisville, Kentucky 40213
Contact:
502-515-5672

Skylight Health Research - Burlington
Burlington, Massachusetts 01803
Contact:
781-653-4281

Ellipsis Research Group - Brooklyn - 7th Street
Brooklyn, New York 11215
Contact:
347-422-0317

Rochester Clinical Research - Buffalo
Buffalo, New York 14127

NYC Research INC
Long Island City, New York 11106
Contact:
516-574-9232

Rochester Clinical Research, LLC
Rochester, New York 14609
Contact:
585-288-0890

Central States Research
Tulsa, Oklahoma 74136
Contact:
918-645-5400

Keystone Clinical Studies
Plymouth Meeting, Pennsylvania 19462

JCCT - Juno Bellaire Site
Bellaire, Texas 77401
Contact:
713-779-5494

Epic Medical Research - DeSoto
DeSoto, Texas 75115
Contact:
197-277-7695

Valley Institute of Research - Fort Worth
Fort Worth, Texas 76164
Contact:
817-625-7733

Care Access - Houston
Houston, Texas 77054
Contact:
877-791-0656

VIP Trials
San Antonio, Texas 78230
Contact:
210-569-2672

Endeavor Clinical Trials
San Antonio, Texas 78240
Contact:
518-428-6859

Consano Clinical Research, LLC
Shavano Park, Texas 78231
Contact:
210-545-4900

Texas Valley Clinical Research
Weslaco, Texas 78596
Contact:
956-431-8090

AMR Clinical
South Jordan, Utah 84095

Dorado Medical Complex
Dorado, Puerto Rico 00646
Contact:
787278-1576

GCM Medical Group, PSC - Hato Rey Site
San Juan, Puerto Rico 00917
Contact:
17877268396

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