NCT07282600

Brief Summary

The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo for body weight reduction in participants with overweight or obesity and type 2 diabetes. Participation in the study will last about 75 weeks.

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
1,035

participants targeted

Target at P75+ for phase_3

Timeline
21mo left

Started Dec 2025

Geographic Reach
14 countries

159 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 Progress18%
Dec 2025Feb 2028

First Submitted

Initial submission to the registry

December 5, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

December 5, 2025

Last Update Submit

April 16, 2026

Conditions

Keywords

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Percent Change from Baseline in Body Weight

    Baseline, Week 64

Secondary Outcomes (16)

  • Percent Change from Baseline in Total Body Fat Mass

    Baseline, Week 64

  • Change from Baseline in Waist Circumference

    Baseline, Week 64

  • Change from Baseline in Hemoglobin A1c (HbA1c)

    Baseline, Week 64

  • Percent Change in Baseline in Triglycerides

    Baseline, Week 64

  • Change from Baseline in Systolic Blood Pressure

    Baseline, Week 64

  • +11 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

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

Administered SC

Placebo

Eligibility Criteria

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

You may qualify if:

  • Have type 2 diabetes
  • Are on stable treatment for type 2 diabetes for at least 90 days prior to screening
  • Have a BMI ≥ 27 kg/m2
  • Have a stable body weight (\<5% body weight change) for 90 days prior to screening

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
  • Have taken any of the following antihyperglycemic medications within 90 days before screening:
  • amylin analogs
  • glucagon-like peptide-1 (GLP-1) receptor agonists
  • glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 (GIP/GLP) receptor agonists, or
  • insulin
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (159)

Birmingham Clinical Research

Birmingham, Alabama, 35209, United States

RECRUITING

Cullman Clinical Trials

Cullman, Alabama, 35055, United States

RECRUITING

Tucson Clinical Research Institute

Tucson, Arizona, 85712, United States

RECRUITING

San Fernando Valley Health Institute

Canoga Park, California, 91304, United States

RECRUITING

AMCR Institute

Escondido, California, 92025, United States

RECRUITING

NorCal Medical Research, Inc

Greenbrae, California, 94904, United States

RECRUITING

Inglewood Clinical

Inglewood, California, 90301, United States

RECRUITING

Ark Clinical Research

Long Beach, California, 90815, United States

RECRUITING

Pacific Clinical Studies

Los Alamitos, California, 90720, United States

RECRUITING

Care Access - Santa Clarita

Santa Clarita, California, 91321, United States

RECRUITING

Encompass Clinical Research

Spring Valley, California, 91978, United States

RECRUITING

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

RECRUITING

Care Access - Aurora

Aurora, Colorado, 80012, United States

RECRUITING

New England Research Associates, LLC

Bridgeport, Connecticut, 06606, United States

RECRUITING

CMR of Greater New Haven, LLC

Hamden, Connecticut, 06517, United States

RECRUITING

Arrow Clinical Trials

Daytona Beach, Florida, 32117, United States

RECRUITING

Care Access - Delray Beach

Delray Beach, Florida, 33484, United States

RECRUITING

Fleming Island Center for Clinical Research

Fleming Island, Florida, 32003, United States

RECRUITING

Nature Coast Clinical Research - Inverness

Inverness, Florida, 34452, United States

RECRUITING

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

RECRUITING

Flourish Research Acquisition, LLC dba Flourish Research - North Miami

Miami, Florida, 33138, United States

RECRUITING

New Horizon Research Center

Miami, Florida, 33165, 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

Clinical Site Partners, LLC dba Flourish Research

Winter Park, Florida, 32789, United States

RECRUITING

Teak Research Consults - Dunwoody

Dunwoody, Georgia, 30338, United States

RECRUITING

Teak Research Consults

Lawrenceville, Georgia, 30043, United States

RECRUITING

The Jones Center Clinical Research

Macon, Georgia, 31210, United States

RECRUITING

Pacific Diabetes & Endocrine Center

Honolulu, Hawaii, 96817, United States

RECRUITING

NorthShore University Health System

Skokie, Illinois, 60077, United States

RECRUITING

DM Clinical Research - Indianapolis

Indianapolis, Indiana, 46254, United States

RECRUITING

Clinical Trials Management, LLC d/b/a Flourish Research

Metairie, Louisiana, 70006, United States

RECRUITING

IMA Clinical Research Monroe - Armand

Monroe, Louisiana, 71201, United States

RECRUITING

Centennial Medical Group

Columbia, Maryland, 21045, United States

RECRUITING

Lucida Clinical Trials

New Bedford, Massachusetts, 02740, United States

RECRUITING

Clinical Research Professionals

Chesterfield, Missouri, 63005, United States

RECRUITING

Clinvest Headlands Llc

Springfield, Missouri, 65807, United States

RECRUITING

Hypertension & Nephrology Association

Eatontown, New Jersey, 07724, United States

RECRUITING

IMA Clinical Research Warren

Warren Township, New Jersey, 07059, United States

RECRUITING

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102, United States

RECRUITING

NYC Research INC

Long Island City, New York, 11106, United States

RECRUITING

PharmQuest Life Sciences, LLC

Greensboro, North Carolina, 27408, United States

RECRUITING

West Clinical Research

Morehead City, North Carolina, 28557, United States

RECRUITING

Trial Management Associates - Wilmington - Floral Parkway

Wilmington, North Carolina, 28403, United States

RECRUITING

Lillestol Research

Fargo, North Dakota, 58104, United States

RECRUITING

Care Access - Lima

Lima, Ohio, 45805, United States

RECRUITING

Summit Headlands

Portland, Oregon, 97210, United States

RECRUITING

Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair

Pittsburgh, Pennsylvania, 15243, United States

RECRUITING

Preferred Primary Care Physicians

Uniontown, Pennsylvania, 15401, United States

RECRUITING

Accellacare - Mt Pleasant

Mt. Pleasant, South Carolina, 29464, United States

RECRUITING

IMA Clinical Research Austin

Austin, Texas, 78745, United States

RECRUITING

Private Practice - Dr. Osvaldo A. Brusco

Corpus Christi, Texas, 78414, United States

RECRUITING

Velocity Clinical Research, Dallas

Dallas, Texas, 75230, United States

RECRUITING

Diabetes and Thyroid Center of Ft. Worth

Fort Worth, Texas, 76132, United States

RECRUITING

Juno Research

Houston, Texas, 77040, United States

RECRUITING

Southern Endocrinology Associates

Mesquite, Texas, 75149, United States

RECRUITING

Research Your Health

Plano, Texas, 75093, United States

RECRUITING

IMA Clinical Research San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Ogden Clinic - Canyon View

Ogden, Utah, 84404, United States

RECRUITING

Diabetes & Endocrine Treatment Specialists

Sandy City, Utah, 84093, United States

RECRUITING

Stat Research S.A.

Buenos Aires, C1023AAB, Argentina

NOT YET RECRUITING

Investigaciones Medicas Imoba Srl

Buenos Aires, C1056ABH, Argentina

NOT YET RECRUITING

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, C1056ABI, Argentina

NOT YET RECRUITING

Mautalen Salud e Investigación

Buenos Aires, C1128AAF, Argentina

NOT YET RECRUITING

Asociación de Beneficencia Hospital Sirio Libanés

Buenos Aires, C1419AHN, Argentina

NOT YET RECRUITING

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, C1425AGC, Argentina

NOT YET RECRUITING

Instituto Centenario

CABA, 1204, Argentina

NOT YET RECRUITING

Centro Diabetológico Dr. Waitman

Córdoba, 5000, Argentina

NOT YET RECRUITING

Centro de Investigaciones Clínicas Baigorria

Granadero Baigorria, 2152, Argentina

NOT YET RECRUITING

Fundacion Estudios Clinicos

Rosario, 2000, Argentina

NOT YET RECRUITING

Instituto Médico Catamarca IMEC

Rosario, 2000, Argentina

NOT YET RECRUITING

Luhe Hospital

Beijing, 100000, China

NOT YET RECRUITING

Peking University People's Hospital

Beijing, 100034, 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

The Second Affiliated Hospital Chongqing Medical University

Chongqing, 400010, 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

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, 210011, China

NOT YET RECRUITING

Jiading District Central Hospital

Shanghai, 201800, China

NOT YET RECRUITING

The Second Hospital of Tianjin Medical University

Tianjin, 300211, China

NOT YET RECRUITING

Zigong First People's Hospital

Zigong, 643000, China

NOT YET RECRUITING

MUDr. Tomas Edelsberger

Krnov, 79401, Czechia

RECRUITING

MUDr. Miroslav Koliba s.r.o.

Ostrava, 702 00, Czechia

RECRUITING

MUDr. Jana Parkanyiova

Prague, 110 00, Czechia

RECRUITING

Diabet2 s.r.o., diabetologicka a interni ambulance

Prague, 11000, Czechia

RECRUITING

Diabetespraxis Dr. Braun

Berlin, 13187, Germany

RECRUITING

Private Practice - Dr. Kai Könemann & Dr. Henrik Könemann

Bünde, 32257, Germany

NOT YET RECRUITING

InnoDiab Forschung Gmbh

Essen, 45136, Germany

RECRUITING

Diabetes Zentrum Wilhelmsburg

Hamburg, 21109, Germany

RECRUITING

Institut für Diabetesforschung GmbH Münster

Münster, 48145, Germany

RECRUITING

Schwerpunktpraxis für Diabetes und Ernährungsmedizin Dr. med. Winfried Keuthage

Münster, 48153, Germany

RECRUITING

RED-Institut GmbH

Oldenburg, 23758, Germany

RECRUITING

Life Care Hospital and Research Centre

Bangalore, 560092, India

NOT YET RECRUITING

Belagavi Institute of Medical Sciences - Belagavi

Belgavi, 590019, India

NOT YET RECRUITING

Dr. Ram Manohar Lohia Institute of Medical Sciences

Lucknow, 226010, India

NOT YET RECRUITING

All India Institute of Medical Sciences (AIIMS) - Nagpur

Nagpur, 441108, India

NOT YET RECRUITING

Lifepoint Multispeciality Hospital

Pune, 411057, India

NOT YET RECRUITING

Ashirwad Hospital and Research Centre

Ulhasnagar, 421004, India

NOT YET RECRUITING

Hayashi Diabetes Internal Medicine Clinic

Chigasaki, 253-0044, Japan

RECRUITING

Tokyo-Eki Center-building Clinic

Chūōku, 103-0027, Japan

RECRUITING

Shonan Takai Clinic

Kamakura, 247-0055, Japan

RECRUITING

Oishi Clinic

Kasuya-gun, 811-2310, Japan

RECRUITING

OHAMA Diabetes Clinic

Kawaguchi, 332-0015, Japan

RECRUITING

Higashijujo Sakai Diabetes Internal Medicine Clinic

Kita-ku, 114-0001, Japan

RECRUITING

Tokuyama Clinic

Mihama-ku,Chiba City, 261-0004, Japan

RECRUITING

Shinkenko clinic

Naha, 900-0015, Japan

RECRUITING

Oyama East Clinic

Oyama, 323-0022, Japan

RECRUITING

Shimokitazawa Tomo Clinic

Setagaya-ku, 155-0031, Japan

RECRUITING

Soka Sugiura Internal Medicine Clinic

Sōka, 340-0015, Japan

RECRUITING

Tsuchiura Medical & Health Care Center

Tsuchiura, 300-0012, Japan

RECRUITING

Tsuchiura Beryl Clinic

Tsuchiura, 300-0062, Japan

RECRUITING

Noritake Clinic

Ushiku, 300-1207, Japan

RECRUITING

Yokohama Minoru Clinic

Yokohama, 232-0064, Japan

RECRUITING

Centro de Investigacion Medica de Occidente, S.C.

Guadalajara, 44260, Mexico

NOT YET RECRUITING

Instituto Jalisciense de Investigacion en Diabetes y Obesidad

Guadalajara, 44600, Mexico

NOT YET RECRUITING

Unidad de Investigación Clínica y Atención Médica HEPA S.C.

Guadalajara, 44670, Mexico

NOT YET RECRUITING

Medical Care and Research SA de CV

Mérida, 97070, Mexico

NOT YET RECRUITING

Cardiolink Clin Trials

Monterrey, 64060, Mexico

NOT YET RECRUITING

Niepubliczny Specjalistyczny Zaklad Opieki Zdrowotnej Osrodek Diabetologiczny Popula Spolka Cywilna

Bialystok, 15445, Poland

NOT YET RECRUITING

Centrum Medyczne NEUROMED

Bydgoszcz, 85-163, Poland

NOT YET RECRUITING

Ambulatorium Sp. z o.o.

Elblag, 82-300, Poland

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

Ekamed

Lublin, 20-718, Poland

RECRUITING

NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki

Ruda Śląska, 41-709, Poland

RECRUITING

Samodzielny Publiczny Szpital Kliniczny nr 1 SUM

Zabrze, 41-800, Poland

NOT YET RECRUITING

Centro de Endocrinologia y Nutricion

Caguas, 00725, Puerto Rico

RECRUITING

Dorado Medical Complex

Dorado, 00646, Puerto Rico

RECRUITING

Diacrin s.r.o.

Bratislava, 83101, Slovakia

NOT YET RECRUITING

MediVet s.r.o.

Malacky, 901 01, Slovakia

RECRUITING

B-Medical, s.r.o.

Námestovo, 02901, Slovakia

NOT YET RECRUITING

FUNKYSTUFF s.r.o.

Nové Zámky, 940 02, Slovakia

RECRUITING

DIA-MED CENTRUM s.r.o.

Púchov, 020 01, Slovakia

RECRUITING

MEDI-DIA s.r.o.

Sabinov, 083 01, Slovakia

RECRUITING

Korea University Ansan Hospital

Ansan-si, 15355, South Korea

NOT YET RECRUITING

Hanyang University Guri Hospital

Guri-si, 11923, South Korea

NOT YET RECRUITING

Chosun University Hospital

Gwangju, 61453, South Korea

NOT YET RECRUITING

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

NOT YET RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

NOT YET RECRUITING

Hospital Universitario de La Ribera

Alzira, 46600, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Complejo Hospitalario Ruber Juan Bravo

Madrid, 28006, Spain

RECRUITING

H.R.U Málaga - Hospital Civil

Málaga, 29009, Spain

NOT YET RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

RECRUITING

Centro Médico Compostela

Santiago de Compostela, 15702, Spain

RECRUITING

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

RECRUITING

Vithas Hospital Sevilla

Seville, 41950, Spain

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

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, 333, Taiwan

NOT YET RECRUITING

Related Links

MeSH Terms

Conditions

OverweightObesityDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

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 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

December 5, 2025

First Posted

December 15, 2025

Study Start

December 15, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

April 17, 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 must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations