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)
Status: Recruiting
Location: See all (155) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
AMR Clinical
RECRUITING
Mobile
Arizona
Care Access - 801 South Power Road, Mesa
RECRUITING
Mesa
Elite Pain and Spine Institute - South Crimson Road
RECRUITING
Mesa
Tucson Orthopaedic Institute - North Wyatt Drive
RECRUITING
Tucson
California
Ark Clinical Research - Fountain Valley
RECRUITING
Fountain Valley
Wolverine Clinical Trials
RECRUITING
Santa Ana
Encompass Clinical Research
RECRUITING
Spring Valley
Diablo Clinical Research, Inc.
RECRUITING
Walnut Creek
Florida
Westside Center for Clinical Research
RECRUITING
Jacksonville
Care Access - St. Petersburg
RECRUITING
St. Petersburg
Conquest Research
RECRUITING
Winter Park
Georgia
Orita Clinical Research
RECRUITING
Decatur
Idaho
Medical Research Partners
NOT_YET_RECRUITING
Ammon
Illinois
Great Lakes Clinical Trials - Ravenswood
RECRUITING
Chicago
Indiana
Qualmedica Research, LLC
RECRUITING
Evansville
Kansas
AMR Clinical
RECRUITING
Newton
Kentucky
Monroe Biomedical Research - Louisville
RECRUITING
Louisville
Massachusetts
Skylight Health Research - Burlington
RECRUITING
Burlington
Care Access - Quincy
RECRUITING
Quincy
New York
Ellipsis Research Group - Brooklyn - 7th Street
RECRUITING
Brooklyn
Rochester Clinical Research - Buffalo
RECRUITING
Buffalo
NYC Research INC
RECRUITING
Long Island City
Rochester Clinical Research, LLC
RECRUITING
Rochester
Oklahoma
Central States Research
RECRUITING
Tulsa
Pennsylvania
Heritage Valley Multispecialty Group, Inc
NOT_YET_RECRUITING
Beaver
Keystone Clinical Studies
RECRUITING
Plymouth Meeting
Texas
JCCT - Juno Bellaire Site
RECRUITING
Bellaire
Epic Medical Research - DeSoto
RECRUITING
Desoto
Valley Institute of Research - Fort Worth
RECRUITING
Fort Worth
Care Access - Houston
RECRUITING
Houston
Endeavor Clinical Trials
RECRUITING
San Antonio
VIP Trials
RECRUITING
San Antonio
Consano Clinical Research, LLC
RECRUITING
Shavano Park
Texas Valley Clinical Research
RECRUITING
Weslaco
Utah
AMR Clinical
RECRUITING
South Jordan
Virginia
Charlottesville Medical Research
NOT_YET_RECRUITING
Charlottesville
Washington
Paramount Clinical Research - Data Point Clinical Research
NOT_YET_RECRUITING
Kirkland
Other Locations
Argentina
CARDIAMET Investigaciones Médicas
NOT_YET_RECRUITING
Buenos Aires
Centro Médico Arsema
NOT_YET_RECRUITING
Buenos Aires
Centro Privado de Medicina Familiar / Mindout Research
NOT_YET_RECRUITING
Buenos Aires
Organizacion Medica de Investigacion
NOT_YET_RECRUITING
Buenos Aires
Stat Research S.A.
NOT_YET_RECRUITING
Buenos Aires
Centro de Investigaciones Clínicas Baigorria
NOT_YET_RECRUITING
Granadero Baigorria
INECO Neurociencias Oroño
NOT_YET_RECRUITING
Rosario
Instituto Especialidades de la Salud Rosario
NOT_YET_RECRUITING
Rosario
Medicina Reumatológica
NOT_YET_RECRUITING
San Fernando
Instituto de Alta Complejidad San Isidro
NOT_YET_RECRUITING
San Isidro
Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan
NOT_YET_RECRUITING
San Juan
Centro de Investigaciones Médicas Tucuman
NOT_YET_RECRUITING
San M. De Tucuman
Centro de Investigaciones Reumatológicas
NOT_YET_RECRUITING
San Miguel De Tucumán
Go Centro Medico San Nicolás
NOT_YET_RECRUITING
San Nicolás
Belgium
Antwerp University Hospital
NOT_YET_RECRUITING
Edegem
Reuma Clinic, Locatie Jaarbeurslaan
RECRUITING
Genk
UZ Gent
RECRUITING
Ghent
Kormont
RECRUITING
Kluisbergen
UZ Leuven
RECRUITING
Leuven
Meclinas
RECRUITING
Mechelen
ZNA Jan Palfijn
NOT_YET_RECRUITING
Merksem
Medisch Centrum Latem (Hip Clinic) - Algemeen Ziekenhuis Maria Middelares Location
NOT_YET_RECRUITING
Sint-martens-latem
Brazil
Centro de Pesquisa Sao Lucas
NOT_YET_RECRUITING
Campinas
IBPClin - Instituto Brasil de Pesquisa Clínica
NOT_YET_RECRUITING
Rio De Janeiro
CEPIC - Centro Paulista de Investigação Clínica
NOT_YET_RECRUITING
São Paulo
CPHosp Medicina, Ensino e Pesquisa (CPQuali)
NOT_YET_RECRUITING
São Paulo
Hospital das Clinicas FMUSP
NOT_YET_RECRUITING
São Paulo
INTEGRA - Pesquisa Clínica e Infusões
NOT_YET_RECRUITING
São Paulo
Canada
Apex Trials
RECRUITING
Guelph
Diex Recherche Inc. Division Quebec
RECRUITING
Québec
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
NOT_YET_RECRUITING
Québec
Stouffville Medical Research Institute Inc.
RECRUITING
Stouffville
Dr. Anil K. Gupta Medicine Professional Corporation
RECRUITING
Toronto
Maple Leaf Research
RECRUITING
Toronto
Diex Recherche Inc. Division Victoriaville
RECRUITING
Victoriaville
China
Beijing Ji Shui Tan Hospital
NOT_YET_RECRUITING
Beijing
The First Afflilated Hospital of Bengbu Medical College
NOT_YET_RECRUITING
Bengbu
Jilin Province People's Hospital
NOT_YET_RECRUITING
Changchun
The Second Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
Xiangya Hospital Central South University
NOT_YET_RECRUITING
Changsha
2nd Affiliated Hospital Chongqing Medical Universi
NOT_YET_RECRUITING
Chongqing
The Second Affiliated hospital of Zhejiang University school of medicine
NOT_YET_RECRUITING
Hangzhou
The Second People's Hospital of Hefei
NOT_YET_RECRUITING
Hefei
Jinan Central Hospital
NOT_YET_RECRUITING
Jinan
The First Affiliated Hospital of Henan University of Science &Technology
NOT_YET_RECRUITING
Luoyang
Jiangsu Province Hospital
NOT_YET_RECRUITING
Nanjing
Nanjing First Hospital
NOT_YET_RECRUITING
Nanjing
The Second Affiliated Hospital of Nanjing Medical University
NOT_YET_RECRUITING
Nanjing
Zhongda Hospital Southeast University
NOT_YET_RECRUITING
Nanjing
The first affiliated hospital of Ningbo university
NOT_YET_RECRUITING
Ningbo
Huashan Hospital, Fudan University
NOT_YET_RECRUITING
Shanghai
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Zhongshan Hospital,Fudan University
NOT_YET_RECRUITING
Shanghai
The Second Affiliated Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
Tianjin Hospital
NOT_YET_RECRUITING
Tianjin
The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
Tongji Hospital Tongji Medical,Science & Technology
NOT_YET_RECRUITING
Wuhan
Xianyang Hospital of Yan'an University
NOT_YET_RECRUITING
Xianyang
Denmark
Sanos Clinic - Nordjylland
RECRUITING
Gandrup
Sanos Clinic
RECRUITING
Herlev
Sanos Clinic - Syddanmark
RECRUITING
Vejle
Germany
Siteworks GmbH - Bochum
NOT_YET_RECRUITING
Bochum
Private Practice - Dr. Kai Könemann & Dr. Henrik Könemann
NOT_YET_RECRUITING
Bünde
StudyPoint Duisburg
NOT_YET_RECRUITING
Duisburg
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T
NOT_YET_RECRUITING
Hamburg
Siteworks - Karlsruhe
NOT_YET_RECRUITING
Karlsruhe
AmBeNet GmbH
NOT_YET_RECRUITING
Leipzig
CDG Studienambulanz Hartard
NOT_YET_RECRUITING
München
Dedicated Research Site FutureMeds
NOT_YET_RECRUITING
Offenbach
Japan
National Hospital Organization Chiba Medical Center
RECRUITING
Chiba
Tokyo Asbo Clinic
RECRUITING
Chūōku
Tokyo-Eki Center-building Clinic
RECRUITING
Chūōku
Shin Komonji Hospital
RECRUITING
Kitakyushu-shi
Goto Orthopedic Surgery Clinic
RECRUITING
Miyazaki
Komagidai Clinic
RECRUITING
Nagareyama
Fujigaki Clinic
RECRUITING
Ōita
Saitama City Hospital
RECRUITING
Saitama
Ibaraki Seinan Medical Center Hospital
NOT_YET_RECRUITING
Sashima
Katsura Garden Orthopedics
RECRUITING
Sendai
Ogura Orthopedics Surgery
RECRUITING
Sendai
Ooimachi Orthopedic Surgery and surgery Clinic
RECRUITING
Shinagawa-ku Tokyo
Masumoto Orthopedics Clinic
RECRUITING
Suginami City
National Hospital Organization Toyohashi Medical Center
RECRUITING
Toyohashi
Yamagata Tokushukai Hospital
RECRUITING
Yamagata
Mexico
Investigacion y Biomedicina de Chihuahua
NOT_YET_RECRUITING
Chihuahua City
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
NOT_YET_RECRUITING
Ciudad Madero
Diseno y Planeacion en Investigacion Medica - Guadalajara - Calle Amado Nervo
NOT_YET_RECRUITING
Guadalajara
Unidad de Investigación Clínica y Atención Médica HEPA S.C.
NOT_YET_RECRUITING
Guadalajara
Kohler & Milstein Research S.A. De C.V.
NOT_YET_RECRUITING
Mérida
RM Pharma Specialists - Unidad Especializada en Datos
NOT_YET_RECRUITING
Mexico City
Centro de investigación y control metabólico
NOT_YET_RECRUITING
Monterrey
IMED Internal Medicine Clin Trials
NOT_YET_RECRUITING
Monterrey
UBAM Unidad Biomedica Avanzada Monterrey
NOT_YET_RECRUITING
Monterrey
Puerto Rico
Dorado Medical Complex
RECRUITING
Dorado
GCM Medical Group, PSC - Hato Rey Site
RECRUITING
San Juan
Republic of Korea
Keimyung University Dongsan Hospital
NOT_YET_RECRUITING
Daegu
Boramae Medical Center
NOT_YET_RECRUITING
Dongjak-gu
Asan Medical Center
NOT_YET_RECRUITING
Seoul
Hallym University Kangnam Sacred Heart Hospital
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
NOT_YET_RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
NOT_YET_RECRUITING
Seoul
The Catholic Univ. of Korea Seoul St. Mary's Hospital
NOT_YET_RECRUITING
Seoul
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
NOT_YET_RECRUITING
Uijeongbu-si
Taiwan
Changhua Christian Hospital
NOT_YET_RECRUITING
Changhua County
Chang Gung Memorial Hospital at Kaohsiung
NOT_YET_RECRUITING
Kaohsiung Niao Sung Dist
China Medical University Hospital
NOT_YET_RECRUITING
Taichung
National Cheng Kung University Hospital
NOT_YET_RECRUITING
Tainan
National Taiwan University Hospital
NOT_YET_RECRUITING
Taipei
Taipei Medical University Hospital
NOT_YET_RECRUITING
Taipei
Tri-Service General Hospital
NOT_YET_RECRUITING
Taipei
United Kingdom
Velocity Clinical Research, Bristol
NOT_YET_RECRUITING
Bristol
FutureMeds Glasgow - CPS Research
NOT_YET_RECRUITING
Glasgow
FutureMeds - London
NOT_YET_RECRUITING
London
Futuremeds-Newcastle
NOT_YET_RECRUITING
Newcastle
Atlantic Medical
NOT_YET_RECRUITING
Penzance
Woodstock Bower Surgery
NOT_YET_RECRUITING
Rotherham
Panthera Biopartners - Sheffield
NOT_YET_RECRUITING
Sheffield
Panthera Clinic - York
NOT_YET_RECRUITING
York
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2026-02-09
Estimated Completion Date: 2028-05
Participants
Target number of participants: 900
Treatments
Experimental: Eloralintide (YOA1)
Participants will receive eloralintide subcutaneously (SC)
Placebo_comparator: Placebo (YOA1)
Participants will receive placebo SC
Experimental: Eloralintide (YOA2)
Participants will receive eloralintide SC
Placebo_comparator: Placebo (YOA2)
Participants will receive placebo SC
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company