Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight
Recruiting · NCT07353931 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
EloralintidePlacebo
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 19 US states.
- AMR Clinical - Mobile, Alabama, United States
- Care Access - 801 South Power Road, Mesa - Mesa, Arizona, United States
- Elite Pain and Spine Institute - South Crimson Road - Mesa, Arizona, United States
- Elite Clinical Studies, LLC - Phoenix, Arizona, United States
- Tucson Orthopaedic Institute - North Wyatt Drive - Tucson, Arizona, United States
- Ark Clinical Research - Fountain Valley - Fountain Valley, California, United States
- Wolverine Clinical Trials - Santa Ana, California, United States
- Encompass Clinical Research - Spring Valley, California, United States
- Diablo Clinical Research, Inc. - Walnut Creek, California, United States
- Skylight Health Research - Colorado Springs - Colorado Springs, Colorado, United States
- Westside Center for Clinical Research - Jacksonville, Florida, United States
- Care Access - St. Petersburg - St. Petersburg, Florida, United States
- Conquest Research - Winter Park, Florida, United States
- Orita Clinical Research - Decatur, Georgia, United States
- Medical Research Partners - Ammon, Idaho, United States
- Great Lakes Clinical Trials - Ravenswood - Chicago, Illinois, United States
- Qualmedica Research, LLC - Evansville, Indiana, United States
- AMR Clinical - Newton, Kansas, United States
- Monroe Biomedical Research - Louisville - Louisville, Kentucky, United States
- Skylight Health Research - Burlington - Burlington, Massachusetts, United States
- Care Access - Quincy - Quincy, Massachusetts, United States
- Ellipsis Research Group - Brooklyn - 7th Street - Brooklyn, New York, United States
- Rochester Clinical Research - Buffalo - Buffalo, New York, United States
- NYC Research INC - Long Island City, New York, United States
- Rochester Clinical Research, LLC - Rochester, New York, United States
- Central States Research - Tulsa, Oklahoma, United States
- Keystone Clinical Studies - Plymouth Meeting, Pennsylvania, United States
- JCCT - Juno Bellaire Site - Bellaire, Texas, United States
- Epic Medical Research - DeSoto - DeSoto, Texas, United States
- Valley Institute of Research - Fort Worth - Fort Worth, Texas, United States
- Care Access - Houston - Houston, Texas, United States
- VIP Trials - San Antonio, Texas, United States
- Endeavor Clinical Trials - San Antonio, Texas, United States
- Consano Clinical Research, LLC - Shavano Park, Texas, United States
- Texas Valley Clinical Research - Weslaco, Texas, United States
- AMR Clinical - South Jordan, Utah, United States
- Charlottesville Medical Research - Charlottesville, Virginia, United States
- Paramount Clinical Research - Data Point Clinical Research - Kirkland, Washington, United States
- Beijing Ji Shui Tan Hospital - Beijing, China
- The First Afflilated Hospital of Bengbu Medical College - Bengbu, China
- Siteworks GmbH - Bochum - Bochum, Germany
- Velocity Clinical Research, Bristol - Bristol, United Kingdom
- Pratia Brno - Brno, Czechia
- Revmatologie.s.r.o. - Brno, Czechia
- Centro Privado de Medicina Familiar / Mindout Research - Buenos Aires, Argentina
- CARDIAMET Investigaciones Médicas - Buenos Aires, Argentina
- Organizacion Medica de Investigacion - Buenos Aires, Argentina
- Stat Research S.A. - Buenos Aires, Argentina
- Centro Médico Arsema - Buenos Aires, Argentina
- Private Practice - Dr. Kai Könemann & Dr. Henrik Könemann - Bünde, Germany
- Centro de Pesquisa Sao Lucas - Campinas, Brazil
- Jilin Province People's Hospital - Changchun, China
- The Second Hospital of Jilin University - Changchun, China
- Changhua Christian Hospital - Changhua County, Taiwan
- Xiangya Hospital Central South University - Changsha, China
- National Hospital Organization Chiba Medical Center - Chiba, Japan
- 2nd Affiliated Hospital Chongqing Medical Universi - Chongqing, China
- Tokyo-Eki Center-building Clinic - Chūōku, Japan
- Tokyo Asbo Clinic - Chūōku, Japan
- Keimyung University Dongsan Hospital - Daegu, South Korea
Showing 60 of 152 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →