RecruitingPhase 3NCT07321886

A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Obesity or Overweight, Without Type 2 Diabetes


Sponsor

Eli Lilly and Company

Enrollment

1,980 participants

Start Date

Feb 6, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase. Participation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.


Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • Have Body Mass Index (BMI) at screening of the following:
  • kilogram per square meter (kg/m2) OR
  • kg/m2 with at least one of the following weight-related health conditions at screening:
  • high blood pressure
  • dyslipidemia
  • obstructive sleep apnea, or
  • heart disease
  • Have a stable body weight (\<5% body weight change) for 90 days prior to screening.
  • Have a history of at least one self-reported unsuccessful dietary effort to reduce body weight

Exclusion Criteria11

  • Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed \>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 or type 2 diabetes
  • 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

Interventions

DRUGEloralintide

Administered SC

DRUGPlacebo

Administered SC


Locations(173)

Kormont

Kluisbergen, Belgium

MFA Clinical Research

Tuscaloosa, Alabama, United States

Headlands Research - Scottsdale

Scottsdale, Arizona, United States

Neighborhood Healthcare Institute of Health

Escondido, California, United States

Ark Clinical Research - Fountain Valley

Fountain Valley, California, United States

Desert Oasis Healthcare Medical Group

Palm Springs, California, United States

Peninsula Research Associates

Rolling Hills Estates, California, United States

Care Access - Sacramento

Sacramento, California, United States

Southern California Clinical Research

Santa Ana, California, United States

University Clinical Investigators, Inc.

Tustin, California, United States

Chase Medical Research, LLC

Waterbury, Connecticut, United States

JEM Research Institute

Atlantis, Florida, United States

BioMed Research & Medical Center

Miami, Florida, United States

Adult Medicine of Lake County, Inc.

Mt. Dora, Florida, United States

American Research Centers of Florida

Pembroke Pines, Florida, United States

AHF Pensacola

Pensacola, Florida, United States

IMA Clinical Research St. Petersburg

St. Petersburg, Florida, United States

Teak Research Consults - Dunwoody

Dunwoody, Georgia, United States

Teak Research Consults

Lawrenceville, Georgia, United States

Clinical Research Atlanta

Stockbridge, Georgia, United States

East-West Medical Research Institute

Honolulu, Hawaii, United States

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

Cotton O'Neil Clinical Research Center

Topeka, Kansas, United States

Care Access - Lake Charles (Bayou Pines)

Lake Charles, Louisiana, United States

MedStar Good Samaritan Hospital

Baltimore, Maryland, United States

Jessa Ziekenhuis

Hasselt, Belgium

MedStar Health Research Institute (MedStar Physician Based Research Network)

Hyattsville, Maryland, United States

Care Access - Quincy

Quincy, Massachusetts, United States

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, United States

AMR Clinical

Las Vegas, Nevada, United States

IMA Clinical Research Warren

Warren Township, New Jersey, United States

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, United States

Rochester Clinical Research, LLC

Rochester, New York, United States

Monroe Biomedical Research

Monroe, North Carolina, United States

Preferred Primary Care Physicians

Uniontown, Pennsylvania, United States

Tribe Clinical Research, LLC

Greenville, South Carolina, United States

Accellacare - Mt Pleasant

Mt. Pleasant, South Carolina, United States

AMR Clinical

Nashville, Tennessee, United States

The University of Texas Health Science Center at Houston

Bellaire, Texas, United States

Velocity Clinical Research, Dallas

Dallas, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Discovery Clinical Trials - San Antonio

San Antonio, Texas, United States

IMA Clinical Research San Antonio

San Antonio, Texas, United States

AMR Clinical

Norfolk, Virginia, United States

CONEXA Investigacion Clinica S.A.

Buenos Aires, Argentina

CIPREC

Buenos Aires, Argentina

Cardiología Palermo

Buenos Aires, Argentina

Glenny Corp. S.A.

Buenos Aires, Argentina

CARDIAMET Investigaciones Médicas

Buenos Aires, Argentina

Centro Médico Viamonte

Buenos Aires, Argentina

Consultorio de Investigación Clínica EMO SRL

Buenos Aires, Argentina

Fundación Respirar

Buenos Aires, Argentina

CEDIC

CABA, Argentina

Instituto de Investigaciones Clínicas Córdoba

Córdoba, Argentina

CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

Godoy Cruz, Argentina

INECO Neurociencias Oroño

Rosario, Argentina

Instituto Especialidades de la Salud Rosario

Rosario, Argentina

Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

Rosario, Argentina

Laboratorio de Hemostasia y Trombosis

Rosario, Argentina

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, Argentina

Centro Modelo de Cardiología

San Miguel de Tucumán, Argentina

Centro de Salud e Investigaciones Médicas

Santa Rosa, Argentina

Emeritus Research

Botany, Australia

Core Research Group

Brisbane, Australia

Paratus Clinical Research Canberra

Bruce, Australia

Emeritus Research

Camberwell, Australia

Life Clinical Research

Ipswich, Australia

Paratus Clinical Research Central Coast

Kanwal, Australia

University of the Sunshine Coast (UniSC) Clinical Trials - Meadowbrook

Meadowbrook, Australia

Momentum Sunshine

Melbourne, Australia

Paratus Clinical Research - Melbourne

Melbourne, Australia

AIM Research

Merewether, Australia

Fusion Clinical Research

Norwood, Australia

USC Clinical Trials Sunshine Coast

Sippy Downs, Australia

ANIMA Research

Alken, Belgium

Gezondheidshuis De Gloed

Machelen, Belgium

Chronos Pesquisa Clínica

Brasília, Brazil

Instituto de Pesquisa clinica de Campinas

Campinas, Brazil

Centro de Pesquisa Sao Lucas

Campinas, Brazil

Private Practice - Dr.Miguel N. Hissa

Fortaleza, Brazil

Centro de Pesquisa Clínica de Marília - CPCLIM

Marília, Brazil

Núcleo de Pesquisa Clínica do Rio Grande do Sul

Porto Alegre, Brazil

IBPClin - Instituto Brasil de Pesquisa Clínica

Rio de Janeiro, Brazil

Ruschel Medicina e Pesquisa Clínica

Rio de Janeiro, Brazil

CPHosp Medicina, Ensino e Pesquisa (CPQuali)

São Paulo, Brazil

CPCLIN

São Paulo, Brazil

CEPIC - Centro Paulista de Investigação Clínica

São Paulo, Brazil

CEDOES

Vitória, Brazil

Integral Pesquisa e Ensino

Votuporanga, Brazil

Aggarwal and Associates Limited

Brampton, Canada

Med Trust Research

Courtice, Canada

Dawson Clinical Research Inc.

Guelph, Canada

Winterberry Research Inc.

Hamilton, Canada

The Wharton Medical Clinic Clinical Trials Inc

Hamilton, Canada

Alpha Recherche Clinique

Québec, Canada

ALPHA Recherche Clinique

Québec, Canada

Bluewater Clinical Research Group Inc.

Sarnia, Canada

Diex Recherche Inc. Division Trois-Rivieres

Trois-Rivières, Canada

Luhe Hospital

Beijing, China

Beijing Pinggu District Hospital

Beijing, China

Sichuan Provincial People's Hospital

Chengdu, China

West China Hospital Sichuan University

Chengdu, China

Zhujiang Hospital

Guangzhou, China

The Second People's Hospital of Hefei

Hefei, China

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang Shi, China

Jiangxi Provincial People's Hospital

Nanchang, China

Nanjing First Hospital

Nanjing, China

Jiangsu Province Official Hospital

Nanjing, China

Zhongda Hospital Southeast University

Nanjing, China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, China

Shanghai Sixth People's Hospital

Shanghai, China

Zentrum fur klinische Forschung - Köln

Cologne, Germany

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, Germany

StudyPoint Duisburg

Duisburg, Germany

InnoDiab Forschung Gmbh

Essen, Germany

Medizentrum Essen Borbeck

Essen, Germany

Diabetes Zentrum Wilhelmsburg

Hamburg, Germany

Diabeteszentrum Hamburg West

Hamburg, Germany

AmBeNet GmbH

Leipzig, Germany

Diabetologische Schwerpunktpraxis Dr. Staudenmeyer & Dr. Schiwietz

Lingen, Germany

BAG Drs. Med. Quist PartG

Mainz, Germany

CRS Clinical Research Services Mannheim

Mannheim, Germany

RED-Institut GmbH

Oldenburg, Germany

Praxis Sauter & Sauter & Vorbach

Wangen, Germany

Endolife Speciality Hospitals

Guntur, India

Gauhati Medical College and Hospital

Guwahati, India

Care Hospitals Hyderabad- Banjara Hills

Hyderabad, India

Mandya Institute Of Medical Sciences

Mandya, India

Topiwala National Medical College & B. Y. L. Nair Charitable Hospital

Mumbai, India

Mysore Medical College

Mysore, India

All India Institute of Medical Sciences (AIIMS) - Nagpur

Nagpur, India

Supe Heart & Diabetes Hospital and Research Centre

Nashik, India

Lifepoint Multispeciality Hospital

Pune, India

Prabhu Diabetes Multi-Speciality Centre

Trichy, India

Adachi Kyosai Hospital

Adachi-ku, Japan

Nihonbashi Sakura Clinic

Chūōku, Japan

Medical Corporation Chiseikai Tokyo Center Clinic

Chūōku, Japan

Tokyo-Eki Center-building Clinic

Chūōku, Japan

Boocs Clinic Fukuoka

Fukuoka, Japan

Patient First Clinic Ginza-Shimbashi

Minato, Japan

Kanno Naika

Mitaka, Japan

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, Japan

Higashi Shinjuku Clinic

Tokyo, Japan

Zdrowie Osteo-Medic

Bialystok, Poland

Legeartis - Poradnie Specjalistyczne

Bialystok, Poland

Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET

Krakow, Poland

Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

Lodz, Poland

Gabinety TERPA

Lublin, Poland

Ekamed

Lublin, Poland

Centrum Zdrowia Metabolicznego Pawel Bogdanski

Poznan, Poland

Pracownia Badań Klinicznych Salus

Wroclaw, Poland

Samodzielny Publiczny Szpital Kliniczny nr 1 SUM

Zabrze, Poland

Puerto Rico Health and Wellness Institute

Dorado, Puerto Rico

Wellness clinical Research Vega Baja

Vega Baja, Puerto Rico

Gachon University Gil Medical Center

Namdong-gu, South Korea

Konyang University Hospital

Seogu, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

Seoul National University Hospital

Seoul, South Korea

Pusan National University Yangsan Hospital

Yangsan, South Korea

Chiayi Christian Hospital

Chiayi City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung Niao Sung Dist, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Layton Medical Centre

Blackpool, United Kingdom

Bradford on Avon Health Centre

Bradford-on-Avon, United Kingdom

Ashton Medical Group - Chapel House

Lancashire, United Kingdom

Royal Lancaster Infirmary

Lancaster, United Kingdom

Altnagelvin Area Hospital

Londonderry, United Kingdom

Bodyline Clinic - Openshaw

Manchester, United Kingdom

Wansford Research Limited

Peterborough, United Kingdom

Abbeywell Surgery

Romsey, United Kingdom

Rame Group Practice

Torpoint, United Kingdom

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