Clinical trial

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

Recruiting now · Phase 3 · 5 countries · Registry ID NCT07353931

Recruiting nowPhase 3Interventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionOsteoarthritis, Overweight or Obesity

Full registry 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

Treatments and study arms

Eloralintide

Drug

Administered SC

Placebo

Drug

Placebo administered SC

Primary outcomes

Percent Change from Baseline in Body WeightBaseline, Week 64

Percent Change from Baseline in Body Weight

Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale ScoreBaseline, Week 64

Change from Baseline in the WOMAC Pain Subscale Score

Study locations

152 locations were listed when this page was built. The first 40 are shown.

CARDIAMET Investigaciones Médicas🇦🇷 Buenos Aires, Argentina
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Virginia DuriganPrincipal Investigator
Centro Médico Arsema🇦🇷 Buenos Aires, Argentina
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Federico ArielPrincipal Investigator
Centro Privado de Medicina Familiar / Mindout Research🇦🇷 Buenos Aires, Argentina
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Leonardo NaftalPrincipal Investigator
Organizacion Medica de Investigacion🇦🇷 Buenos Aires, Argentina
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Patricio TatePrincipal Investigator
Stat Research S.A.🇦🇷 Buenos Aires, Argentina
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ALEJANDRO ARROYOPrincipal Investigator
Centro de Investigaciones Clínicas Baigorria🇦🇷 Granadero Baigorria, Argentina
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Juan EscalantePrincipal Investigator
INECO Neurociencias Oroño🇦🇷 Rosario, Argentina
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Florencia GaravelliPrincipal Investigator
Instituto Especialidades de la Salud Rosario🇦🇷 Rosario, Argentina
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Julieta GentilettiPrincipal Investigator
Centro de Investigaciones Médicas Tucuman🇦🇷 SAN M. de Tucuman, Argentina
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Walter SpindlerPrincipal Investigator
Medicina Reumatológica🇦🇷 San Fernando, Argentina
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Maria CusaPrincipal Investigator
Instituto de Alta Complejidad San Isidro🇦🇷 San Isidro, Argentina
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Maria LazaroPrincipal Investigator
Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan🇦🇷 San Juan, Argentina
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Rodolfo Pardo HidalgoPrincipal Investigator
Centro de Investigaciones Reumatológicas🇦🇷 San Miguel de Tucumán, Argentina
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Luciana Gonzalez LuceroPrincipal Investigator
Go Centro Medico San Nicolás🇦🇷 San Nicolás, Argentina
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Paulina LanchiottiPrincipal Investigator
Antwerp University Hospital🇧🇪 Edegem, Belgium
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eveline dirinckPrincipal Investigator
Reuma Clinic, Locatie Jaarbeurslaan🇧🇪 Genk, Belgium
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Johan VanhoofPrincipal Investigator
UZ Gent🇧🇪 Ghent, Belgium
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Ruth WittoekPrincipal Investigator
Kormont🇧🇪 Kluisbergen, Belgium
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Klaas VercruyssePrincipal Investigator
UZ Leuven🇧🇪 Leuven, Belgium
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Kurt de VlamPrincipal Investigator
Meclinas🇧🇪 Mechelen, Belgium
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Julie CasaerPrincipal Investigator
ZNA Jan Palfijn🇧🇪 Merksem, Belgium
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Alla IshchenkoPrincipal Investigator
Medisch Centrum Latem (Hip Clinic) - Algemeen Ziekenhuis Maria Middelares Location🇧🇪 Sint-Martens-Latem, Belgium
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Pieter VansintjanPrincipal Investigator
Centro de Pesquisa Sao Lucas🇧🇷 Campinas, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica🇧🇷 Rio de Janeiro, Brazil
CEPIC - Centro Paulista de Investigação Clínica🇧🇷 São Paulo, Brazil
CPHosp Medicina, Ensino e Pesquisa (CPQuali)🇧🇷 São Paulo, Brazil
Hospital das Clinicas FMUSP🇧🇷 São Paulo, Brazil
INTEGRA - Pesquisa Clínica e Infusões🇧🇷 São Paulo, Brazil
Apex Trials🇨🇦 Guelph, Canada
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Ken WooPrincipal Investigator
Diex Recherche Inc. Division Quebec🇨🇦 Québec, Canada
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Caroline RheaumePrincipal Investigator
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.🇨🇦 Québec, Canada
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Louis BessettePrincipal Investigator
Stouffville Medical Research Institute Inc.🇨🇦 Stouffville, Canada
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Nima MirtorabiPrincipal Investigator
Dr. Anil K. Gupta Medicine Professional Corporation🇨🇦 Toronto, Canada
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Anil GuptaPrincipal Investigator
Maple Leaf Research🇨🇦 Toronto, Canada
Mona LoutfyPrincipal Investigator
Diex Recherche Inc. Division Victoriaville🇨🇦 Victoriaville, Canada
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Eve BetitPrincipal Investigator
Beijing Ji Shui Tan Hospital🇨🇳 Beijing, China
Xiaoli DengPrincipal Investigator
The First Afflilated Hospital of Bengbu Medical College🇨🇳 Bengbu, China
Xiaoyun FanPrincipal Investigator
Jilin Province People's Hospital🇨🇳 Changchun, China
Guoping JiangPrincipal Investigator
The Second Hospital of Jilin University🇨🇳 Changchun, China
Hanqing CaiPrincipal Investigator
Xiangya Hospital Central South University🇨🇳 Changsha, China
Wenfeng XiaoPrincipal Investigator