NCT07321886

Brief 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.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
1,980

participants targeted

Target at P75+ for phase_3 obesity

Timeline
51mo left

Started Feb 2026

Longer than P75 for phase_3 obesity

Geographic Reach
15 countries

173 active sites

Status
recruiting

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

Study Progress6%
Feb 2026Jul 2030

First Submitted

Initial submission to the registry

January 5, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

February 6, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

January 5, 2026

Last Update Submit

April 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percent Change from Baseline in Body Weight

    Baseline, Week 64

Secondary Outcomes (18)

  • Percent Change from Baseline in Total Body Fat Mass

    Baseline, Week 64

  • Change from Baseline in Waist Circumference

    Baseline, Week 64

  • Percent Change from Baseline in Triglycerides

    Baseline, Week 64

  • Change from Baseline in Systolic Blood Pressure (SBP)

    Baseline, Week 64

  • Time to Onset of Type 2 Diabetes (T2D)

    Baseline to Week 168 and Week 191

  • +13 more secondary outcomes

Study Arms (5)

Eloralintide Dose 1

EXPERIMENTAL

Participants will receive eloralintide subcutaneously (SC)

Drug: Eloralintide

Eloralintide Dose 2

EXPERIMENTAL

Participants will receive eloralintide SC

Drug: Eloralintide

Eloralintide Dose 3

EXPERIMENTAL

Participants will receive eloralintide SC

Drug: Eloralintide

Eloralintide Dose 4

EXPERIMENTAL

Participants will receive eloralintide SC

Drug: Eloralintide

Placebo

PLACEBO COMPARATOR

Participants will receive placebo SC

Drug: Placebo

Interventions

Administered SC

Placebo

Administered SC

Also known as: LY3841136
Eloralintide Dose 1Eloralintide Dose 2Eloralintide Dose 3Eloralintide Dose 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (173)

MFA Clinical Research

Tuscaloosa, Alabama, 35405, United States

RECRUITING

Headlands Research - Scottsdale

Scottsdale, Arizona, 85260, United States

RECRUITING

Neighborhood Healthcare Institute of Health

Escondido, California, 92025, United States

RECRUITING

Ark Clinical Research - Fountain Valley

Fountain Valley, California, 92708, United States

RECRUITING

Desert Oasis Healthcare Medical Group

Palm Springs, California, 92262, United States

RECRUITING

Peninsula Research Associates

Rolling Hills Estates, California, 90274, United States

RECRUITING

Care Access - Sacramento

Sacramento, California, 95831, United States

RECRUITING

Southern California Clinical Research

Santa Ana, California, 92701, United States

RECRUITING

University Clinical Investigators, Inc.

Tustin, California, 92780, United States

RECRUITING

Chase Medical Research, LLC

Waterbury, Connecticut, 06708, United States

RECRUITING

JEM Research Institute

Atlantis, Florida, 33462, United States

RECRUITING

BioMed Research & Medical Center

Miami, Florida, 33156, United States

RECRUITING

Adult Medicine of Lake County, Inc.

Mt. Dora, Florida, 32757, United States

RECRUITING

American Research Centers of Florida

Pembroke Pines, Florida, 33027, United States

RECRUITING

AHF Pensacola

Pensacola, Florida, 32503, United States

RECRUITING

IMA Clinical Research St. Petersburg

St. Petersburg, Florida, 33704, United States

RECRUITING

Teak Research Consults - Dunwoody

Dunwoody, Georgia, 30338, United States

RECRUITING

Teak Research Consults

Lawrenceville, Georgia, 30043, United States

RECRUITING

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

RECRUITING

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

RECRUITING

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, 50266, United States

RECRUITING

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66606, United States

RECRUITING

Care Access - Lake Charles (Bayou Pines)

Lake Charles, Louisiana, 70601, United States

RECRUITING

MedStar Good Samaritan Hospital

Baltimore, Maryland, 21239, United States

RECRUITING

MedStar Health Research Institute (MedStar Physician Based Research Network)

Hyattsville, Maryland, 20782, United States

RECRUITING

Care Access - Quincy

Quincy, Massachusetts, 02169, United States

RECRUITING

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, 48098, United States

RECRUITING

AMR Clinical

Las Vegas, Nevada, 89119, United States

NOT YET RECRUITING

IMA Clinical Research Warren

Warren Township, New Jersey, 07059, United States

RECRUITING

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102, United States

RECRUITING

Rochester Clinical Research, LLC

Rochester, New York, 14609, United States

RECRUITING

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

RECRUITING

Preferred Primary Care Physicians

Uniontown, Pennsylvania, 15401, United States

RECRUITING

Tribe Clinical Research, LLC

Greenville, South Carolina, 29607, United States

RECRUITING

Accellacare - Mt Pleasant

Mt. Pleasant, South Carolina, 29464, United States

RECRUITING

AMR Clinical

Nashville, Tennessee, 37203, United States

RECRUITING

The University of Texas Health Science Center at Houston

Bellaire, Texas, 77401, United States

RECRUITING

Velocity Clinical Research, Dallas

Dallas, Texas, 75230, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390-9302, United States

RECRUITING

IMA Clinical Research San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

AMR Clinical

Norfolk, Virginia, 23502, United States

RECRUITING

CONEXA Investigacion Clinica S.A.

Buenos Aires, 1012, Argentina

NOT YET RECRUITING

CIPREC

Buenos Aires, 1061, Argentina

NOT YET RECRUITING

Cicemo Srl

Buenos Aires, 1424, Argentina

NOT YET RECRUITING

Cardiología Palermo

Buenos Aires, 1425, Argentina

NOT YET RECRUITING

Glenny Corp. S.A.

Buenos Aires, 1430, Argentina

NOT YET RECRUITING

CARDIAMET Investigaciones Médicas

Buenos Aires, C1014ACP, Argentina

NOT YET RECRUITING

Centro Médico Viamonte

Buenos Aires, C1120AAC, Argentina

NOT YET RECRUITING

Fundación Respirar

Buenos Aires, C1426ABP, Argentina

NOT YET RECRUITING

CEDIC

CABA, C1060ABN, Argentina

NOT YET RECRUITING

Instituto de Investigaciones Clínicas Córdoba

Córdoba, 5000, Argentina

NOT YET RECRUITING

CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

Godoy Cruz, M5501ARP, Argentina

NOT YET RECRUITING

INECO Neurociencias Oroño

Rosario, 2000, Argentina

NOT YET RECRUITING

Instituto Especialidades de la Salud Rosario

Rosario, 2000, Argentina

NOT YET RECRUITING

Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

Rosario, 2000, Argentina

NOT YET RECRUITING

Laboratorio de Hemostasia y Trombosis

Rosario, S2000DTB, Argentina

NOT YET RECRUITING

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, T4000AXL, Argentina

NOT YET RECRUITING

Centro Modelo de Cardiología

San Miguel de Tucumán, 4000, Argentina

NOT YET RECRUITING

Centro de Salud e Investigaciones Médicas

Santa Rosa, L6300, Argentina

NOT YET RECRUITING

Emeritus Research

Botany, 2019, Australia

NOT YET RECRUITING

Core Research Group

Brisbane, 4064, Australia

NOT YET RECRUITING

Paratus Clinical Research Canberra

Bruce, 2617, Australia

NOT YET RECRUITING

Emeritus Research

Camberwell, 3124, Australia

NOT YET RECRUITING

Life Clinical Research

Ipswich, 4305, Australia

NOT YET RECRUITING

Paratus Clinical Research Central Coast

Kanwal, 2259, Australia

NOT YET RECRUITING

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

Meadowbrook, 4131, Australia

NOT YET RECRUITING

Momentum Sunshine

Melbourne, 3021, Australia

NOT YET RECRUITING

Paratus Clinical Research - Melbourne

Melbourne, 3070, Australia

NOT YET RECRUITING

AIM Research

Merewether, 2291, Australia

NOT YET RECRUITING

Fusion Clinical Research

Norwood, 5067, Australia

NOT YET RECRUITING

USC Clinical Trials Sunshine Coast

Sippy Downs, 4556, Australia

NOT YET RECRUITING

ANIMA Research

Diepenbeek, 3590, Belgium

RECRUITING

Jessa Ziekenhuis

Hasselt, 3500, Belgium

NOT YET RECRUITING

Kormont

Kluisbergen, 9690, Belgium

RECRUITING

Gezondheidshuis De Gloed

Machelen, 9870, Belgium

RECRUITING

Chronos Pesquisa Clínica

Brasília, 72145-450, Brazil

NOT YET RECRUITING

Instituto de Pesquisa clinica de Campinas

Campinas, 13060-080, Brazil

NOT YET RECRUITING

Centro de Pesquisa Sao Lucas

Campinas, 13060-803, Brazil

NOT YET RECRUITING

Private Practice - Dr.Miguel N. Hissa

Fortaleza, 60430-350, Brazil

NOT YET RECRUITING

Centro de Pesquisa Clínica de Marília - CPCLIM

Marília, 17504-072, Brazil

NOT YET RECRUITING

Núcleo de Pesquisa Clínica do Rio Grande do Sul

Porto Alegre, 90430-001, Brazil

NOT YET RECRUITING

IBPClin - Instituto Brasil de Pesquisa Clínica

Rio de Janeiro, 20241-180, Brazil

NOT YET RECRUITING

Ruschel Medicina e Pesquisa Clínica

Rio de Janeiro, 22270-060, Brazil

NOT YET RECRUITING

CPHosp Medicina, Ensino e Pesquisa (CPQuali)

São Paulo, 01228-000, Brazil

NOT YET RECRUITING

CPCLIN

São Paulo, 01228-200, Brazil

NOT YET RECRUITING

CEPIC - Centro Paulista de Investigação Clínica

São Paulo, 04266-010, Brazil

NOT YET RECRUITING

CEDOES

Vitória, 29055450, Brazil

NOT YET RECRUITING

Integral Pesquisa e Ensino

Votuporanga, 15500-269, Brazil

NOT YET RECRUITING

Aggarwal and Associates Limited

Brampton, L6T 0G1, Canada

RECRUITING

Med Trust Research

Courtice, L1E 2J5, Canada

RECRUITING

Dawson Clinical Research Inc.

Guelph, N1H 1B1, Canada

RECRUITING

Winterberry Research Inc.

Hamilton, L8J 0B6, Canada

RECRUITING

The Wharton Medical Clinic Clinical Trials Inc

Hamilton, L8L 5G8, Canada

RECRUITING

Alpha Recherche Clinique

Québec, G2J 0C4, Canada

RECRUITING

ALPHA Recherche Clinique

Québec, G3K 2P8, Canada

RECRUITING

Bluewater Clinical Research Group Inc.

Sarnia, N7T 4X3, Canada

RECRUITING

Diex Recherche Inc. Division Trois-Rivieres

Trois-Rivières, G9A 4P3, Canada

RECRUITING

Luhe Hospital

Beijing, 1001199, China

NOT YET RECRUITING

Beijing Pinggu District Hospital

Beijing, 101200, China

NOT YET RECRUITING

Sichuan Provincial People's Hospital

Chengdu, 610072, China

NOT YET RECRUITING

West China Hospital Sichuan University

Chengdu, 610041, China

NOT YET RECRUITING

Zhujiang Hospital

Guangzhou, 510280, China

NOT YET RECRUITING

The Second People's Hospital of Hefei

Hefei, 230011, China

NOT YET RECRUITING

Jinan Central Hospital

Jinan, 250013, China

NOT YET RECRUITING

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang Shi, 471003, China

NOT YET RECRUITING

Jiangxi Provincial People's Hospital

Nanchang, 330006, China

NOT YET RECRUITING

Nanjing First Hospital

Nanjing, 210006, China

NOT YET RECRUITING

Jiangsu Province Official Hospital

Nanjing, 210008, China

NOT YET RECRUITING

Zhongda Hospital Southeast University

Nanjing, 210009, China

NOT YET RECRUITING

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, 210011, China

NOT YET RECRUITING

Shanghai Sixth People's Hospital

Shanghai, China

NOT YET RECRUITING

Zentrum fur klinische Forschung - Köln

Cologne, 51069, Germany

RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

NOT YET RECRUITING

StudyPoint Duisburg

Duisburg, 47269, Germany

RECRUITING

InnoDiab Forschung Gmbh

Essen, 45136, Germany

RECRUITING

Medizentrum Essen Borbeck

Essen, 45355, Germany

RECRUITING

Diabetes Zentrum Wilhelmsburg

Hamburg, 21109, Germany

RECRUITING

Diabeteszentrum Hamburg West

Hamburg, 22607, Germany

NOT YET RECRUITING

AmBeNet GmbH

Leipzig, 04107, Germany

RECRUITING

Diabetologische Schwerpunktpraxis Dr. Staudenmeyer & Dr. Schiwietz

Lingen, 49808, Germany

RECRUITING

BAG Drs. Med. Quist PartG

Mainz, 55128, Germany

NOT YET RECRUITING

CRS Clinical Research Services Mannheim

Mannheim, 68167, Germany

NOT YET RECRUITING

RED-Institut GmbH

Oldenburg, 23758, Germany

RECRUITING

Praxis Sauter & Sauter & Vorbach

Wangen, 88239, Germany

NOT YET RECRUITING

Endolife Speciality Hospitals

Guntur, 522001, India

NOT YET RECRUITING

Gauhati Medical College and Hospital

Guwahati, 781032, India

NOT YET RECRUITING

Care Hospitals Hyderabad- Banjara Hills

Hyderabad, 500034, India

NOT YET RECRUITING

Mandya Institute Of Medical Sciences

Mandya, 571401, India

NOT YET RECRUITING

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

Mumbai, 400008, India

NOT YET RECRUITING

Mysore Medical College

Mysore, 570001, India

NOT YET RECRUITING

All India Institute of Medical Sciences (AIIMS) - Nagpur

Nagpur, 441108, India

NOT YET RECRUITING

Supe Heart & Diabetes Hospital and Research Centre

Nashik, 422002, India

NOT YET RECRUITING

Lifepoint Multispeciality Hospital

Pune, 411057, India

NOT YET RECRUITING

Prabhu Diabetes Multi-Speciality Centre

Trichy, 620001, India

NOT YET RECRUITING

Adachi Kyosai Hospital

Adachi-ku, 120-0022, Japan

RECRUITING

Nihonbashi Sakura Clinic

Chūōku, 103-0025, Japan

RECRUITING

Medical Corporation Chiseikai Tokyo Center Clinic

Chūōku, 103-0027, Japan

RECRUITING

Tokyo-Eki Center-building Clinic

Chūōku, 103-0027, Japan

RECRUITING

Boocs Clinic Fukuoka

Fukuoka, 812-0025, Japan

RECRUITING

Patient First Clinic Ginza-Shimbashi

Minato, 105-0004, Japan

RECRUITING

Kanno Naika

Mitaka, 181-0013, Japan

RECRUITING

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, 565-0853, Japan

RECRUITING

Higashi Shinjuku Clinic

Tokyo, 169-0072, Japan

RECRUITING

Zdrowie Osteo-Medic

Bialystok, 15-351, Poland

RECRUITING

Legeartis - Poradnie Specjalistyczne

Bialystok, 15-404, Poland

NOT YET RECRUITING

Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET

Krakow, 31-261, Poland

RECRUITING

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

Lodz, 90-338, Poland

RECRUITING

Gabinety TERPA

Lublin, 20-333, Poland

NOT YET RECRUITING

Ekamed

Lublin, 20-718, Poland

RECRUITING

Centrum Zdrowia Metabolicznego Pawel Bogdanski

Poznan, 60-589, Poland

RECRUITING

Pracownia Badań Klinicznych Salus

Wroclaw, 53-034, Poland

RECRUITING

Samodzielny Publiczny Szpital Kliniczny nr 1 SUM

Zabrze, 41-800, Poland

NOT YET RECRUITING

Puerto Rico Health and Wellness Institute

Dorado, 00646, Puerto Rico

RECRUITING

Wellness clinical Research Vega Baja

Vega Baja, 00693, Puerto Rico

RECRUITING

Gachon University Gil Medical Center

Namdong-gu, 21565, South Korea

NOT YET RECRUITING

Konyang University Hospital

Seogu, 35365, South Korea

NOT YET RECRUITING

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

NOT YET RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

NOT YET RECRUITING

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

NOT YET RECRUITING

Chiayi Christian Hospital

Chiayi City, 600, Taiwan

NOT YET RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

NOT YET RECRUITING

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung Niao Sung Dist, 83301, Taiwan

NOT YET RECRUITING

National Taiwan University Hospital

Taipei, 10002, Taiwan

NOT YET RECRUITING

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

NOT YET RECRUITING

Layton Medical Centre

Blackpool, FY3 7EN, United Kingdom

NOT YET RECRUITING

Bradford on Avon Health Centre

Bradford-on-Avon, BA15 1DQ, United Kingdom

NOT YET RECRUITING

Ashton Medical Group - Chapel House

Lancashire, OL6 6EW, United Kingdom

NOT YET RECRUITING

Royal Lancaster Infirmary

Lancaster, LA1 4RP, United Kingdom

NOT YET RECRUITING

Altnagelvin Area Hospital

Londonderry, BT47 6SB, United Kingdom

NOT YET RECRUITING

Bodyline Clinic - Openshaw

Manchester, M11 1AA, United Kingdom

NOT YET RECRUITING

Wansford Research Limited

Peterborough, PE8 6PL, United Kingdom

NOT YET RECRUITING

Abbeywell Surgery

Romsey, SO51 7QN, United Kingdom

NOT YET RECRUITING

Rame Group Practice

Torpoint, PL11 2TB, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    STUDY DIRECTOR

Central Study Contacts

Trial question 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 5, 2026

First Posted

January 7, 2026

Study Start

February 6, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

July 1, 2030

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

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 should be approved by an independent review panel and researchers should sign a data sharing agreement.
More information

Locations