Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight
ENLIGHTEN-4
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)
5 other identifiers
interventional
900
15 countries
155
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2026
155 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2026
CompletedFirst Posted
Study publicly available on registry
January 21, 2026
CompletedStudy Start
First participant enrolled
February 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
March 20, 2026
March 1, 2026
2.1 years
January 16, 2026
March 19, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Percent Change from Baseline in Body Weight
Percent Change from Baseline in Body Weight
Baseline, Week 64
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Change from Baseline in the WOMAC Pain Subscale Score
Baseline, Week 64
Secondary Outcomes (24)
Change from Baseline in Systolic Blood Pressure (SBP)
Baseline, Week 64
Percent Change from Baseline in Triglycerides
Baseline, Week 64
Change from Baseline in Short Form-36 (SF-36 v2) Acute Form Physical Functioning Domain Score
Baseline, Week 64
Percent Change from Baseline in High Sensitivity, C-reactive Protein (hsCRP)
Baseline, Week 64
Change from Baseline in the WOMAC Physical Function Subscale Score
Baseline, Week 40, Week 64
- +19 more secondary outcomes
Study Arms (4)
Eloralintide (YOA1)
EXPERIMENTALParticipants will receive eloralintide subcutaneously (SC)
Placebo (YOA1)
PLACEBO COMPARATORParticipants will receive placebo SC
Eloralintide (YOA2)
EXPERIMENTALParticipants will receive eloralintide SC
Placebo (YOA2)
PLACEBO COMPARATORParticipants will receive placebo SC
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (155)
AMR Clinical
Mobile, Alabama, 36608, United States
Care Access - 801 South Power Road, Mesa
Mesa, Arizona, 85206, United States
Elite Pain and Spine Institute - South Crimson Road
Mesa, Arizona, 85209, United States
Tucson Orthopaedic Institute - North Wyatt Drive
Tucson, Arizona, 85712, United States
Ark Clinical Research - Fountain Valley
Fountain Valley, California, 92708, United States
Wolverine Clinical Trials
Santa Ana, California, 92706, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Westside Center for Clinical Research
Jacksonville, Florida, 32205, United States
Care Access - St. Petersburg
St. Petersburg, Florida, 33710, United States
Conquest Research
Winter Park, Florida, 32789, United States
Orita Clinical Research
Decatur, Georgia, 30034, United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60640, United States
Qualmedica Research, LLC
Evansville, Indiana, 47715, United States
AMR Clinical
Newton, Kansas, 67114, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Skylight Health Research - Burlington
Burlington, Massachusetts, 01803, United States
Care Access - Quincy
Quincy, Massachusetts, 02169, United States
Ellipsis Research Group - Brooklyn - 7th Street
Brooklyn, New York, 11215, United States
Rochester Clinical Research - Buffalo
Buffalo, New York, 14127, United States
NYC Research INC
Long Island City, New York, 11106, United States
Rochester Clinical Research, LLC
Rochester, New York, 14609, United States
AMC Research, LLC
Matthews, North Carolina, 28105, United States
Central States Research
Tulsa, Oklahoma, 74136, United States
Heritage Valley Multispecialty Group, Inc
Beaver, Pennsylvania, 15009, United States
Keystone Clinical Studies
Plymouth Meeting, Pennsylvania, 19462, United States
JCCT - Juno Bellaire Site
Bellaire, Texas, 77401, United States
Epic Medical Research - DeSoto
DeSoto, Texas, 75115, United States
Valley Institute of Research - Fort Worth
Fort Worth, Texas, 76164, United States
Care Access - Houston
Houston, Texas, 77054, United States
VIP Trials
San Antonio, Texas, 78230, United States
Endeavor Clinical Trials
San Antonio, Texas, 78240, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
Texas Valley Clinical Research
Weslaco, Texas, 78596, United States
AMR Clinical
South Jordan, Utah, 84095, United States
Centro Privado de Medicina Familiar / Mindout Research
Buenos Aires, 1417, Argentina
Organizacion Medica de Investigacion
Buenos Aires, C1015ABO, Argentina
Stat Research S.A.
Buenos Aires, C1023AAB, Argentina
CIPREC
Buenos Aires, C1119ACN, Argentina
Centro Médico Arsema
Buenos Aires, C1427CCL, Argentina
APRILLUS Asistencia E Investigacion
CABA, 1406, Argentina
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria, 2152, Argentina
INECO Neurociencias Oroño
Rosario, 2000, Argentina
Instituto Especialidades de la Salud Rosario
Rosario, 2000, Argentina
Medicina Reumatológica
San Fernando, 1646, Argentina
Instituto de Alta Complejidad San Isidro
San Isidro, 1642, Argentina
Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan
San Juan, 5400, Argentina
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, T4000AXL, Argentina
Centro de Investigaciones Reumatológicas
San Miguel de Tucumán, 4000, Argentina
Go Centro Medico San Nicolás
San Nicolás, 2900, Argentina
Antwerp University Hospital
Edegem, 2650, Belgium
Reuma Clinic, Locatie Jaarbeurslaan
Genk, 3600, Belgium
UZ Gent
Ghent, 9000, Belgium
Kormont
Kluisbergen, 9690, Belgium
UZ Leuven
Leuven, 3000, Belgium
Meclinas
Mechelen, 2800, Belgium
ZNA Jan Palfijn
Merksem, 2170, Belgium
Medisch Centrum Latem (Hip Clinic) - Algemeen Ziekenhuis Maria Middelares Location
Sint-Martens-Latem, 9830, Belgium
Centro de Pesquisa Sao Lucas
Campinas, 13060-803, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, 20241-180, Brazil
CPHosp Medicina, Ensino e Pesquisa (CPQuali)
São Paulo, 01228-000, Brazil
INTEGRA - Pesquisa Clínica e Infusões
São Paulo, 04039-002, Brazil
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010, Brazil
Hospital das Clinicas FMUSP
São Paulo, 05403-000, Brazil
Apex Trials
Guelph, N1G 0B4, Canada
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
Québec, G1V 3M7, Canada
Diex Recherche Inc. Division Quebec
Québec, G1V 4T3, Canada
Stouffville Medical Research Institute Inc.
Stouffville, L4A 1H2, Canada
Maple Leaf Research
Toronto, M5G 1K2, Canada
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto, M9V 4B4, Canada
Diex Recherche Inc. Division Victoriaville
Victoriaville, G6P 3Z8, Canada
Beijing Ji Shui Tan Hospital
Beijing, 100035, China
The First Afflilated Hospital of Bengbu Medical College
Bengbu, 233004, China
Jilin Province People's Hospital
Changchun, 130021, China
Xiangya Hospital Central South University
Changsha, 410008, China
2nd Affiliated Hospital Chongqing Medical Universi
Chongqing, 400000, China
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, 350005, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, 310016, China
The Second Affiliated hospital of Zhejiang University school of medicine
Hangzhou, 310052, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, 471003, China
Nanjing First Hospital
Nanjing, 210006, China
Zhongda Hospital Southeast University
Nanjing, 210009, China
The first affiliated hospital of Ningbo university
Ningbo, 315010, China
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200023, China
Zhongshan Hospital,Fudan University
Shanghai, 200032, China
Huashan Hospital, Fudan University
Shanghai, 200040, China
The University of Hong Kong-Shenzhen Hospital
Shenzhen, 518053, China
The Second Affiliated Hospital of Soochow University
Suzhou, 215004, China
Tianjin Hospital
Tianjin, 300211, China
Tongji Hospital Tongji Medical,Science & Technology
Wuhan, 430030, China
Pratia Brno
Brno, 602 00, Czechia
Revmatologie.s.r.o.
Brno, 63800, Czechia
INREA s.r.o.
Ostrava, 70300, Czechia
Pratia Pardubice a.s.
Pardubice, 53002, Czechia
Medical Plus Research
Uherské Hradiště, 686 01, Czechia
Sanos Clinic - Nordjylland
Gandrup, 9362, Denmark
Sanos Clinic
Herlev, 2730, Denmark
Sanos Clinic - Syddanmark
Vejle, 7100, Denmark
Siteworks GmbH - Bochum
Bochum, 44787, Germany
Private Practice - Dr. Kai Könemann & Dr. Henrik Könemann
Bünde, 32257, Germany
StudyPoint Duisburg
Duisburg, 47269, Germany
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T
Hamburg, 20095, Germany
Siteworks - Karlsruhe
Karlsruhe, 76137, Germany
AmBeNet GmbH
Leipzig, 04107, Germany
CDG Studienambulanz Hartard
München, 80809, Germany
Dedicated Research Site FutureMeds
Offenbach, 63065, Germany
National Hospital Organization Chiba Medical Center
Chiba, 260-8606, Japan
Tokyo-Eki Center-building Clinic
Chūōku, 103-0027, Japan
Tokyo Asbo Clinic
Chūōku, 104-0031, Japan
Shin Komonji Hospital
Kitakyushu-Shi, 800-0057, Japan
Goto Orthopedic Surgery Clinic
Miyazaki, 880-0835, Japan
Komagidai Clinic
Nagareyama, 270-0113, Japan
Fujigaki Clinic
Ōita, 870-0942, Japan
Saitama City Hospital
Saitama, 336-8522, Japan
Ibaraki Seinan Medical Center Hospital
Sashima, 306-0433, Japan
Ogura Orthopedics Surgery
Sendai, 980-0011, Japan
Katsura Garden Orthopedics
Sendai, 981-3134, Japan
Ooimachi Orthopedic Surgery and surgery Clinic
Shinagawa-ku Tokyo, 140-0014, Japan
Masumoto Orthopedics Clinic
Suginami City, 167-0051, Japan
National Hospital Organization Toyohashi Medical Center
Toyohashi, 440-8510, Japan
Yamagata Tokushukai Hospital
Yamagata, 990-0834, Japan
Investigacion y Biomedicina de Chihuahua
Chihuahua City, 31000, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
Ciudad Madero, 89440, Mexico
Diseno y Planeacion en Investigacion Medica - Guadalajara - Calle Amado Nervo
Guadalajara, 44600, Mexico
Unidad de Investigación Clínica y Atención Médica HEPA S.C.
Guadalajara, 44670, Mexico
RM Pharma Specialists - Unidad Especializada en Datos
Mexico City, 03100, Mexico
Kohler & Milstein Research S.A. De C.V.
Mérida, 97070, Mexico
IMED Internal Medicine Clin Trials
Monterrey, 64020, Mexico
UBAM Unidad Biomedica Avanzada Monterrey
Monterrey, 64460, Mexico
Centro de investigación y control metabólico
Monterrey, 66465, Mexico
Dorado Medical Complex
Dorado, 00646, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
San Juan, 00917, Puerto Rico
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
Boramae Medical Center
Dongjak-gu, 07061, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441, South Korea
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, 11765, South Korea
Changhua Christian Hospital
Changhua County, 50006, Taiwan
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, 83301, Taiwan
China Medical University Hospital
Taichung, 404332, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Medical University Hospital
Taipei, 110, Taiwan
Tri-Service General Hospital
Taipei, 114, Taiwan
Velocity Clinical Research, Bristol
Bristol, BS8 2RA, United Kingdom
FutureMeds Glasgow - CPS Research
Glasgow, G20 7BE, United Kingdom
FutureMeds - London
London, NW10 2PB, United Kingdom
Futuremeds-Newcastle
Newcastle, NE6 1SG, United Kingdom
Atlantic Medical
Penzance, TR18 3DX, United Kingdom
Woodstock Bower Surgery
Rotherham, S61 1AH, United Kingdom
Panthera Biopartners - Sheffield
Sheffield, S2 5FX, United Kingdom
Panthera Clinic - York
York, YO24 4LJ, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2026
First Posted
January 21, 2026
Study Start
February 9, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
March 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.