New weekly shot could help severely obese heart patients shed pounds

NCT ID NCT05882045

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This Phase 3 study tests a weekly injection called retatrutide in about 1,946 people with severe obesity (BMI ≥35) and established heart disease. The goal is to see if it helps with weight loss and improves heart-related health measures over 113 weeks compared to a placebo. Participants must have tried and failed to lose weight through diet before.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Retatrutide (a weekly injection)
What this could lead to: If it works, this could provide a new treatment option for weight loss and improved heart health in people with severe obesity and existing cardiovascular disease.
What could go wrong: This is a large Phase 3 trial, but results are not yet available. The drug may cause side effects, and weight loss may not translate into better heart outcomes for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,946 people

The number who actually took part.

Started

May 2023

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Have a body mass index (BMI) ≥35.0 kilogram/square meter (kg/m²). * Have established cardiovascular (CV) disease with at least 1 of the following: * prior myocardial infarction * prior ischemic or hemorrhagic stroke, or * symptomatic peripheral arterial disease * Have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight. Exclusion Criteria: * Have had acute myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure within 90 days prior to screening. * Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening. * Have a prior or planned surgical treatment of obesity. * Have a change in body weight greater than 5 kg (11 pounds) within 90 days prior to screening. * Have Type 1 diabetes. * Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) * Have had pancreatitis.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder morbid obesity Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases Obesity

Contacts and locations

Locations

Advanced Research Institute

Ogden, Utah, 84405, United States
Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635, United States
Ambulatorium Sp. z o.o.

Elblag, Warmian-Masurian Voivodeship, 82-300, Poland
Areteus s.r.o.

Trebišov, Košice Region, 075 01, Slovakia
Austin Health - Repatriation Hospital

Heidelberg West, Victoria, 3081, Australia
BC Diabetes Office

Vancouver, British Columbia, V5Y 3W2, Canada
Barwon Health

Geelong, Victoria, 3220, Australia
Box Hill Hospital

Box Hill, Victoria, 3128, Australia
Brengle Family Medicine

Indianapolis, Indiana, 46260, United States
C.I.C. Mauricie inc.

Trois-Rivières, Quebec, G8T 7A1, Canada
CDH Research Institute

Maroochydore, Queensland, 4558, Australia
CEDIC

CABA, Buenos Aires, C1060ABN, Argentina
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

Godoy Cruz, Mendoza Province, 5501, Argentina
Camden Hospital

Camden, New South Wales, 2570, Australia
Canberra Hospital

Canberra, Australian Capital Territory, 2605, Australia
CardioVasc HR Inc

Saint-Jean-sur-Richelieu, Quebec, J3A 1J2, Canada
Carteret Medical Group

Morehead City, North Carolina, 28557, United States
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative

Springfield, Illinois, 62711, United States
Central Phoenix Medical Clinic

Phoenix, Arizona, 85020, United States
Centre de Medecine Metabolique de Lanaudiere (CMML)

Terrebonne, Quebec, J6X 4P7, Canada
Centricity Research Oshawa

Oshawa, Ontario, L1J 2K9, Canada
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

Mexico City, Mexico City, 11650, Mexico
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, Buenos Aires F.D., C1425AGC, Argentina
Centro Medico Privado CEMAIC

Capital, Córdoba Province, X5008HHW, Argentina
Centro Medico Privado San Vicente Diabetes

Córdoba, Córdoba Province, 5006, Argentina
Centro Multidisciplinario de Diabetes de Pachuca

Pachuca, Hidalgo, 42084, Mexico
Centro Médico Viamonte

Buenos Aires, Buenos Aires F.D., C1120AAC, Argentina
Centro de Atención e Investigación Cardiovascular del Potosí

San Luis Potosí City, San Luis Potosí, 78200, Mexico
Centro de Investigacion Cardiovascular y Metabólica

Tijuana, Estado de Baja California, 22500, Mexico
Centro de Investigacion Medica de Occidente, S.C.

Zapopan, Jalisco, 44260, Mexico
Centro de Investigaciones Clinicas del Litoral

Santa Fe, Santa Fe Province, S3000FWO, Argentina
Centro de Investigaciones Clínicas Baigorria

Granadero Baigorria, Santa Fe Province, 2152, Argentina
Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1056, Argentina
Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, Tucumán Province, T4000AXL, Argentina
Centro de Salud e Investigaciones Médicas

Santa Rosa, La Pampa Province, 6300, Argentina
Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Pomeranian Voivodeship, 80-546, Poland
Centrum Medyczne Pratia Katowice

Katowice, Silesian Voivodeship, 40-081, Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

Lodz, Łódź Voivodeship, 90338, Poland
Charter Research - Winter Park

Orlando, Florida, 32803, United States
Chase Medical Research, LLC

Waterbury, Connecticut, 06708, United States
Cleveland Clinic

Cleveland, Ohio, 44195, United States
ClinDiab Kft.

Budapest, Budapest, 1089, Hungary
Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Jacksonville, Florida, 32256, United States
Clinical Research Management Group Inc

Ponce, 00717, Puerto Rico
Clinique de médecine Urbaine du Quartier Latin

Montreal, Quebec, H2L 4E9, Canada
Clínica García Flores SC

Monterrey, Nuevo León, 64610, Mexico
Collaborative Neuroscience Research, LLC

Los Alamitos, California, 90720, United States
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval

Ferrol, A Coruña [La Coruña], 15405, Spain
Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States
Consultorio de Investigación Clínica EMO SRL

Buenos Aires, Buenos Aires F.D., 1405, Argentina
Core Research Group

Brisbane, Queensland, 4064, Australia
Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, 66606, United States
DIM Clínica Privada

Ramos Mejía, Buenos Aires, B1704ETD, Argentina
DRC Gyógyszervizsgáló Központ

Balatonfüred, Veszprém megye, 8230, Hungary
Debreceni Egyetem Klinikai Központ

Debrecen, Debrecen, 4031, Hungary
Diab - Int

Bytča, Žilina Region, 014 01, Slovakia
Discovery Clinical Services

Victoria, British Columbia, V8T 5G4, Canada
Dr. Steven V. Zizzo Research Professional Corporation

Hamilton, Ontario, L8J 0B6, Canada
EME RED Hospitalaria

Mérida, Yucatán, 97000, Mexico
Ecogene-21

Chicoutimi, Quebec, G7H 7K9, Canada
Ecogene-21 - Cmas

Chicoutimi, Quebec, G7H 0S7, Canada
Elite Clinical Trials

Blackfoot, Idaho, 83221, United States
Emeritus Research

Botany, New South Wales, 2019, Australia
Emeritus Research

Camberwell, Victoria, 3124, Australia
Eukarya PharmaSite

Monterrey, Nuevo León, 64718, Mexico
FAICIC S. de R.L. de C.V.

Veracruz, Veracruz, 91900, Mexico
Fundación Respirar

Buenos Aires, Buenos Aires, C1426ABP, Argentina
Fusion Clinical Research

Adelaide, South Australia, 5000, Australia
Great Lakes Clinical Trials - Gurnee

Gurnee, Illinois, 60031, United States
Hospital General Universitario Gregorio Marañon

Madrid, Madrid, 28009, Spain
Hospital Quiron Infanta Luisa

Seville, Andalusia, 41010, Spain
Hospital Universitari Son Espases

Palma, Balears [Baleares], 07120, Spain
Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], 08035, Spain
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, 66460, Mexico
Hospital Universitario Arnau de Vilanova de Lleida

Lleida, Lleida [Lérida], 25198, Spain
Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain
Hospital Universitario Reina Sofia

Córdoba, Andalusia, 14004, Spain
Hospital Universitario Virgen Del Rocio

Seville, Sevilla, 41013, Spain
Hospital Universitario Virgen de la Victoria

Málaga, Andalusia, 29010, Spain
Hospital Universitario de La Ribera

Alzira, Valenciana, Comunitat, 46600, Spain
Hospital Virgen de las Montañas

Villamartín, Cádiz, 11650, Spain
Hospital Virgen del Camino

Sanlúcar de Barrameda, Cádiz, 11540, Spain
Human Care s.r.o.

Košice, Košice Region, 04001, Slovakia
Humphreys Diabetes Center

Boise, Idaho, 83702, United States
IDIM - Instituto de Investigaciones Metabólicas

Ciudad de Buenos Aires, Buenos Aires, C1012AAR, Argentina
IMA Clinical Research Warren

Warren Township, New Jersey, 07059, United States
IMED Internal Medicine Clin Trials

Monterrey, Nuevo León, 64060, Mexico
INECO Neurociencias Oroño

Rosario, Santa Fe Province, 2000, Argentina
Indago Research & Health Center, Inc

Hialeah, Florida, 33012, United States
Instituto Médico DAMIC

Córdoba, Córdoba Province, 5003DCE, Argentina
Instituto de Investigaciones Clinicas Rosario

Rosario, Santa Fe Province, 2000, Argentina
Instituto de Investigaciones Clínicas Mar del Plata

Mar del Plata, Buenos Aires, 7600, Argentina
Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos

Chihuahua City, Chihuahua, 31110, Mexico
Investigaciones Medicas Imoba Srl

Buenos Aires, Buenos Aires F.D., C1056ABH, Argentina
Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, 50265, United States
Joanne F. Liutkus Medicine Professional Corporation

Cambridge, Ontario, N3H 4L5, Canada
KLIMED Marek Klimkiewicz

Bialystok, Podlaskie Voivodeship, 15-704, Poland
Kawartha Cardiology Clinical Trials

Peterborough, Ontario, K9J 0B2, Canada
LMC Clinical Research Inc. (Thornhill)

Concord, Ontario, L4K 4M2, Canada
Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia

Durango, Durango, 34000, Mexico
Las Vegas Medical Research

Las Vegas, Nevada, 89128, United States
Latin Clinical Trial Center

San Juan, 00909, Puerto Rico
Logan Hospital

Meadowbrook, Queensland, 4131, Australia
MEDI-DIA s.r.o.

Sabinov, Presov, 083 01, Slovakia
MICA - Medicina e Investigación Cardiometabólica

Del Viso, Buenos Aires, 1669, Argentina
Manna Research Toronto

Toronto, Ontario, M9W 4L6, Canada
MedVadis Research Corporation

Waltham, Massachusetts, 02451, United States
MediTask

Bratislava, 831 03, Slovakia
MediVet s.r.o.

Malacky, Bratislava Region, 901 01, Slovakia
Medical Care and Research SA de CV

Mérida, Yucatán, 97070, Mexico
Medifarma 98 Kft

Nyíregyháza, Nyíregyháza, 4400, Hungary
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET

Krakow, Lesser Poland Voivodeship, 31-261, Poland
Metabol KLINIK

Bratislava, Bratislava Region, 811 08, Slovakia
Milestone Research Inc.

London, Ontario, N5W 6A2, Canada
NBR Polska

Warsaw, Masovian Voivodeship, 00-710, Poland
NZOZ Salvia CM

Katowice, Silesian Voivodeship, 40-772, Poland
Nemocnica s poliklinikou Lucenec

Lučenec, Banská Bystrica Region, 984 01, Slovakia
Neuro-Pain Medical Center

Fresno, California, 93710, United States
Nightingale Research

Adelaide, South Australia, 5000, Australia
North York Diagnostic and Cardiac Centre

North York, Ontario, M6B 3H7, Canada
Northern Beaches Clinical Research

Brookvale, New South Wales, 2100, Australia
Northwestern University

Chicago, Illinois, 60611, United States
One Clinical Research

Nedlands, Western Australia, 6009, Australia
Pacific Diabetes & Endocrine Center

Honolulu, Hawaii, 96817, United States
Palm Research Center Tenaya

Las Vegas, Nevada, 89128, United States
Pinnacle Clinical Research

Austin, Texas, 78757, United States
Ponce Medical School Foundation Inc.

Ponce, 00716, Puerto Rico
Progressive Medical Research

Port Orange, Florida, 32127, United States
RM Pharma Specialists

Mexico City, Mexico City, 03100, Mexico
Rainier Clinical Research Center

Renton, Washington, 98057, United States
Regia Med Kft

Székesfehérvár, Fejér, 8000, Hungary
Rochester Clinical Research, LLC

Rochester, New York, 14609, United States
Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia
Samodzielny Publiczny Szpital Kliniczny nr 1 SUM

Zabrze, Silesian Voivodeship, 41-800, Poland
Sanatorio Norte

Santiago del Estero, Santiago del Estero Province, 4200, Argentina
Sanatorio San Martin

Venado Tuerto, Santa Fe Province, 2600, Argentina
Sleep Therapy Research Center

San Antonio, Texas, 78229, United States
South Texas Clinical Research

Corpus Christi, Texas, 78404, United States
Southern Adelaide Diabetes & Endocrine Services

Mount Gambier, South Australia, 5290, Australia
Southern Adelaide Diabetes & Endocrine Services

Oaklands Park, South Australia, 5046, Australia
Southern Endocrinology Associates

Mesquite, Texas, 75149, United States
Stat Research S.A.

Buenos Aires, Buenos Aires F.D., C1023AAB, Argentina
StudyMetrix Research

City of Saint Peters, Missouri, 63303, United States
Syneos Health

Québec, Quebec, G1P0A2, Canada
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

Szeged, Csongrád megye, 6725, Hungary
Szent Lázár Megyei Kórház

Salgótarján, Nógrád megye, 3100, Hungary
TRANTOR'99 Bt. Anyagcsere Centrum

Budapest, Budapest, 1213, Hungary
Tatratrial s.r.o.

Rožňava, Košice Region, 04801, Slovakia
Texas Diabetes & Endocrinology, P.A.

Austin, Texas, 78731, United States
Texas Diabetes & Endocrinology, P.A.

Round Rock, Texas, 78681, United States
The AIM Centre / Hunter Diabetes Centre

Merewether, New South Wales, 2291, Australia
Trial Management Associates

Myrtle Beach, South Carolina, 29572, United States
Tribe Clinical Research - Spartanburg

Spartanburg, South Carolina, 29301, United States
Tribe Clinical Research, LLC

Greenville, South Carolina, 29607, United States
UPMC Montefiore University Hospital

Pittsburgh, Pennsylvania, 15213, United States
Unidad de Investigación Clínica y Atención Médica HEPA

Guadalajara, Jalisco, 44670, Mexico
University of Sydney - Charles Perkins Centre

Sydney, New South Wales, 2006, Australia
Valley Clinical Trials, Inc.

Covina, California, 91723, United States
Valley Clinical Trials, Inc.

Northridge, California, 91325, United States
Valley Research

Fresno, California, 93720, United States
Velocity Clinical Research, Panorama City

Van Nuys, California, 91405, United States
Velocity Clinical Research, Westlake

Los Angeles, California, 90057, United States
Vithas Hospital Sevilla

Seville, Sevilla, 41950, Spain
Weill Cornell Medical College

New York, New York, 10021, United States
Zala Megyei Szent Rafael Kórház

Zalaegerszeg, Zala County, 8900, Hungary
Óbudai Egészségügyi Centrum

Budapest, Budapest, 1036, Hungary
Óbudai Egészségügyi Centrum - Kaposvár Site

Kaposvár, Somogy County, 7400, Hungary
Óbudai Egészségügyi Centrum - Zalaegerszeg

Zalaegerszeg, Zalaegerszeg, 8900, Hungary

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