Recruiting
Phase 3

Eloralintide

Sponsor:

Eli Lilly and Company

Code:

NCT07321886

Conditions

Obesity

Overweight

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Eloralintide

Placebo

Study Details

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.

Conditions

Obesity

Overweight

Study ID

NCT07321886

Start date

Feb 6, 2026

Status verified date

Aug, 2026

Completion date

Jul, 2030

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Have Body Mass Index (BMI) at screening of the following:

  • 30 kilogram per square meter (kg/m2) OR
  • 27 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 Criteria:

  • 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

Study Design

Enrollment

1980 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Eloralintide Dose 1

Participants will receive eloralintide subcutaneously (SC)

experimental: Eloralintide Dose 2

Participants will receive eloralintide SC

experimental: Eloralintide Dose 3

Participants will receive eloralintide SC

experimental: Eloralintide Dose 4

Participants will receive eloralintide SC

placebo comparator: Placebo

Participants will receive placebo SC

Interventions

Eloralintide

Administered SC

Placebo

Administered SC

Primary outcome measure

  • Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 64 ]

Central Contacts and Locations

Central contacts

Trial question or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

MFA Clinical Research

Recruiting

Tuscaloosa, Alabama, United States, 35405

Contacts

Principal Investigator:

Mohammad Aryanpure

Headlands Research - Scottsdale

Recruiting

Scottsdale, Arizona, United States, 85260

Contacts

Principal Investigator:

Benjamin Clark

Neighborhood Healthcare Institute of Health

Recruiting

Escondido, California, United States, 92025

Contacts

Principal Investigator:

James Schultz

Ark Clinical Research - Fountain Valley

Recruiting

Fountain Valley, California, United States, 92708

Contacts

Principal Investigator:

Mark Leibowitz

Desert Oasis Healthcare Medical Group

Recruiting

Palm Springs, California, United States, 92262

Contacts

Principal Investigator:

Michael Jardula

Peninsula Research Associates

Recruiting

Rolling Hills Estates, California, United States, 90274

Contacts

Principal Investigator:

David Guzman

Care Access - Sacramento

Recruiting

Sacramento, California, United States, 95831

Contacts

Principal Investigator:

Francisco Garcia

Southern California Clinical Research

Recruiting

Santa Ana, California, United States, 92701

Contacts

Principal Investigator:

Wayne Ho

University Clinical Investigators, Inc.

Recruiting

Tustin, California, United States, 92780

Contacts

Principal Investigator:

John Kim

Chase Medical Research, LLC

Recruiting

Waterbury, Connecticut, United States, 06708

Contacts

Principal Investigator:

Jenna Langello

JEM Research Institute

Recruiting

Atlantis, Florida, United States, 33462

Contacts

Principal Investigator:

David Halpert

BioMed Research & Medical Center

Recruiting

Miami, Florida, United States, 33156

Contacts

Principal Investigator:

Liliam Hernandez

Adult Medicine of Lake County, Inc.

Recruiting

Mt. Dora, Florida, United States, 32757

Contacts

Principal Investigator:

Shirley Nagel

American Research Centers of Florida

Recruiting

Pembroke Pines, Florida, United States, 33027

Contacts

Principal Investigator:

Luis del Prado Rodriguez

AHF Pensacola

Recruiting

Pensacola, Florida, United States, 32503

Contacts

Principal Investigator:

Mitchell Whitehead

IMA Clinical Research St. Petersburg

Recruiting

St. Petersburg, Florida, United States, 33704

Contacts

Principal Investigator:

Howard Chipman

Teak Research Consults - Dunwoody

Recruiting

Dunwoody, Georgia, United States, 30338

Contacts

Principal Investigator:

Aakar Thaker

Teak Research Consults

Recruiting

Lawrenceville, Georgia, United States, 30043

Principal Investigator:

Kamar Alabi

Clinical Research Atlanta

Recruiting

Stockbridge, Georgia, United States, 30281

Contacts

Principal Investigator:

Jason Agran

East-West Medical Research Institute

Recruiting

Honolulu, Hawaii, United States, 96814

Contacts

Principal Investigator:

Cindy Pau

Iowa Diabetes and Endocrinology Research Center

Recruiting

West Des Moines, Iowa, United States, 50266

Principal Investigator:

Amy Keller

Cotton O'Neil Clinical Research Center

Recruiting

Topeka, Kansas, United States, 66606

Contacts

Principal Investigator:

Katherine Willingham

Care Access - Lake Charles (Bayou Pines)

Recruiting

Lake Charles, Louisiana, United States, 70601

Contacts

Principal Investigator:

William Nabours

MedStar Good Samaritan Hospital

Recruiting

Baltimore, Maryland, United States, 21239

Contacts

Principal Investigator:

Adline Ghazi

MedStar Health Research Institute (MedStar Physician Based Research Network)

Recruiting

Hyattsville, Maryland, United States, 20782

Contacts

Principal Investigator:

Jean Park

Care Access - Quincy

Recruiting

Quincy, Massachusetts, United States, 02169

Contacts

Principal Investigator:

Chih Chao Yang

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Recruiting

Troy, Michigan, United States, 48098

Contacts

Principal Investigator:

Neil Fraser

AMR Clinical

Recruiting

Las Vegas, Nevada, United States, 89119

Contacts

Principal Investigator:

Michael Jacobs

IMA Clinical Research Warren

Recruiting

Warren Township, New Jersey, United States, 07059

Principal Investigator:

Nancy Phillips

Albuquerque Clinical Trials, Inc.

Recruiting

Albuquerque, New Mexico, United States, 87102

Contacts

Principal Investigator:

Satkirin Khalsa

Rochester Clinical Research, LLC

Recruiting

Rochester, New York, United States, 14609

Contacts

Principal Investigator:

Leigh Schirmer

Monroe Biomedical Research

Recruiting

Monroe, North Carolina, United States, 28112

Contacts

Principal Investigator:

Awawu Igbinadolor

Preferred Primary Care Physicians

Recruiting

Uniontown, Pennsylvania, United States, 15401

Contacts

Principal Investigator:

Paul Hartley

Tribe Clinical Research, LLC

Recruiting

Greenville, South Carolina, United States, 29607

Contacts

Principal Investigator:

Ronald Mayfield

Accellacare - Mt Pleasant

Recruiting

Mt. Pleasant, South Carolina, United States, 29464

Contacts

Principal Investigator:

Richard Mills

AMR Clinical

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Principal Investigator:

Harvey Bowles

The University of Texas Health Science Center at Houston

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Principal Investigator:

Deborah Horn

Velocity Clinical Research, Dallas

Recruiting

Dallas, Texas, United States, 75230

Principal Investigator:

Dan Lender

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390-9302

Principal Investigator:

Amy Shah

IMA Clinical Research San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Principal Investigator:

Priscilla Thomas

AMR Clinical

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

Principal Investigator:

Mary Bailey

Aggarwal and Associates Limited

Recruiting

Brampton, Canada, L6T 0G1

Contacts

Principal Investigator:

Naresh Aggarwal

Med Trust Research

Recruiting

Courtice, Canada, L1E 2J5

Contacts

Principal Investigator:

Anojan Kathirkamanayagan

Dawson Clinical Research Inc.

Recruiting

Guelph, Canada, N1H 1B1

Contacts

Principal Investigator:

Garry Wallace

The Wharton Medical Clinic Clinical Trials Inc

Recruiting

Hamilton, Canada, L8L 5G8

Contacts

Principal Investigator:

Mateen Akhtar

Alpha Recherche Clinique

Recruiting

Québec, Canada, G2J 0C4

Contacts

Principal Investigator:

Anne-Marie Beaulieu

ALPHA Recherche Clinique

Recruiting

Québec, Canada, G3K 2P8

Contacts

Principal Investigator:

Maggie Lévesque

Bluewater Clinical Research Group Inc.

Recruiting

Sarnia, Canada, N7T 4X3

Contacts

Principal Investigator:

John O'Mahony

Winterberry Research Inc.

Recruiting

Stoney Creek, Canada, L8J 0B6

Contacts

Principal Investigator:

Steven Zizzo

Diex Recherche Inc. Division Trois-Rivieres

Recruiting

Trois-Rivières, Canada, G9A 4P3

Principal Investigator:

Jean-francois Naud

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-21.