Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight
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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
Two separate studies will test how well eloralintide (LY3841136) works and how safe it is. They are for adults with obesity or overweight who have knee pain from osteoarthritis, a disease that wears down joints. Taking part lasts about 75 weeks, including screening.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have a BMI of 27 or higher at screening. BMI is a measure based on height and weight.
- Have had less than a 5% change in body weight during the 90 days before screening.
- Have tried to lose weight through diet at least once without success.
- Have knee osteoarthritis and at least one of these: be over age 50, have morning knee stiffness lasting about 30 minutes, or have a crackling or grinding sound or feeling in the knee.
Who can't join
- Have had or plan to have surgery for obesity. Liposuction, fat freezing, or a tummy tuck is allowed if done more than 1 year before screening.
- Have had or plan to have an obesity treatment using a scope or device. Past device treatment is allowed if the device was removed more than 6 months before screening.
- Have any type of diabetes.
- Have a current knee infection.
- In the 90 days before screening, had a heart attack, stroke, procedure to restore blood flow to the heart, unstable angina (new or worsening heart-related chest pain), or a hospital stay for heart failure.
- Have or have had Class IV heart failure, the most severe class of heart failure.
- Have used medicines or alternative remedies meant for weight loss within 90 days of screening.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (39)
AL
- AMR Clinical · Mobile, AL 36608 · Study contact · 251-414-1984Harry Studdard · Principal investigatorMore trials in Mobile
AZ
- Care Access - 801 South Power Road, Mesa · Mesa, AZ 85206 · Study contact · 877-791-0656Michael Waters · Principal investigatorMore trials in Mesa
- Elite Pain and Spine Institute - South Crimson Road · Mesa, AZ 85209Zeeshan Malik · Principal investigatorMore trials in Mesa
- Elite Clinical Studies, LLC · Phoenix, AZ 85018 · Study contact · 602-788-3437Joseph Lillo, DO · Principal investigatorMore trials in Phoenix
- Tucson Orthopaedic Institute - North Wyatt Drive · Tucson, AZ 85712 · Study contact · 520-404-0276Nebojsa Skrepnik · Principal investigatorMore trials in Tucson
CA
- Ark Clinical Research - Fountain Valley · Fountain Valley, CA 92708 · Study contact · 714-988-2021Mark Leibowitz · Principal investigatorMore trials in Fountain Valley
- Wolverine Clinical Trials · Santa Ana, CA 92706 · Study contact · 714-617-2426Behnam Khaleghi · Principal investigatorMore trials in Santa Ana
- Encompass Clinical Research · Spring Valley, CA 91978 · Study contact · 619-660-9068Hanid Audish · Principal investigatorMore trials in Spring Valley
- Diablo Clinical Research, Inc. · Walnut Creek, CA 94598 · Study contact · 925-930-7267Helen Stacey · Principal investigatorMore trials in Walnut Creek
CO
- Skylight Health Research - Colorado Springs · Colorado Springs, CO 80917Renee Flick · Principal investigatorMore trials in Colorado Springs
FL
- Westside Center for Clinical Research · Jacksonville, FL 32205 · Study contact · 904-693-1490Matthew Braddock · Principal investigatorMore trials in Jacksonville
- Care Access - St. Petersburg · St. Petersburg, FL 33710 · Study contact · 877-791-0656Gigi Lefebvre · Principal investigatorMore trials in St. Petersburg
- Conquest Research · Winter Park, FL 32789 · Study contact · 407-916-0060Anand Patel · Principal investigatorMore trials in Winter Park
GA
- Orita Clinical Research · Decatur, GA 30034Ahmad Jingo · Principal investigatorMore trials in Decatur
- North Georgia Clinical Research · Woodstock, GA 30189 · Study contact · 678-494-5735Bram Wieskopf · Principal investigatorMore trials in Woodstock
ID
- Medical Research Partners · Ammon, ID 83406 · Study contact · 208-681-9070Joseph Moore · Principal investigatorMore trials in Ammon
IL
- Great Lakes Clinical Trials - Ravenswood · Chicago, IL 60640 · Study contact · 773-275-3500Manish Jain · Principal investigatorMore trials in Chicago
IN
- Qualmedica Research, LLC · Evansville, IN 47715 · Study contact · 812-205-2475Moges Sisay · Principal investigatorMore trials in Evansville
KS
- AMR Clinical · Newton, KS 67114 · Study contact · 316-804-7304Troy Holdeman · Principal investigatorMore trials in Newton
KY
- Monroe Biomedical Research - Louisville · Louisville, KY 40213 · Study contact · 502-515-5672Harold Bays · Principal investigatorMore trials in Louisville
MA
- Skylight Health Research - Burlington · Burlington, MA 01803 · Study contact · 781-653-4281Timothy McAlindon · Principal investigatorMore trials in Burlington
- Care Access - Quincy · Quincy, MA 02169 · Study contact · 877-791-0656Chih Chao Yang · Principal investigatorMore trials in Quincy
NY
- Ellipsis Research Group - Brooklyn - 7th Street · Brooklyn, NY 11215 · Study contact · 347-422-0317Jorge Serje · Principal investigatorMore trials in Brooklyn
- Rochester Clinical Research - Buffalo · Buffalo, NY 14127Rajiv Jain · Principal investigatorMore trials in Buffalo
- NYC Research INC · Long Island City, NY 11106 · Study contact · 516-574-9232Anastasios Manessis · Principal investigatorMore trials in Long Island City
- Rochester Clinical Research, LLC · Rochester, NY 14609 · Study contact · 585-288-0890Patrick Connors · Principal investigatorMore trials in Rochester
OK
- Central States Research · Tulsa, OK 74136 · Study contact · 918-645-5400Sarah Land · Principal investigatorMore trials in Tulsa
PA
- Keystone Clinical Studies · Plymouth Meeting, PA 19462Cameron Olezene · Principal investigatorMore trials in Plymouth Meeting
TX
- JCCT - Juno Bellaire Site · Bellaire, TX 77401 · Study contact · 713-779-5494Rocio Harbison · Principal investigatorMore trials in Bellaire
- Epic Medical Research - DeSoto · DeSoto, TX 75115 · Study contact · 197-277-7695HARESH BOGHARA · Principal investigatorMore trials in DeSoto
- Valley Institute of Research - Fort Worth · Fort Worth, TX 76164 · Study contact · 817-625-7733Alex Guevara · Principal investigatorMore trials in Fort Worth
- Care Access - Houston · Houston, TX 77054 · Study contact · 877-791-0656Ali Bajwa · Principal investigatorMore trials in Houston
- VIP Trials · San Antonio, TX 78230 · Study contact · 210-569-2672Juan Garza · Principal investigatorMore trials in San Antonio
- Endeavor Clinical Trials · San Antonio, TX 78240 · Study contact · 518-428-6859Nitendra Agarwal · Principal investigatorMore trials in San Antonio
- Consano Clinical Research, LLC · Shavano Park, TX 78231 · Study contact · 210-545-4900Michelle Welch · Principal investigatorMore trials in Shavano Park
- Texas Valley Clinical Research · Weslaco, TX 78596 · Study contact · 956-431-8090Eduardo Luna · Principal investigatorMore trials in Weslaco
UT
- AMR Clinical · South Jordan, UT 84095Curtis Andrews · Principal investigatorMore trials in South Jordan
VA
- Charlottesville Medical Research · Charlottesville, VA 22911 · Study contact · 434-817-2442James Clark · Principal investigatorMore trials in Charlottesville
WA
- Paramount Clinical Research - Data Point Clinical Research · Kirkland, WA 98034 · Study contact · 425-577-1107Javier Nazar · Principal investigatorMore trials in Kirkland