A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease (TRIUMPH-3)

July 28, 2026 updated by: Eli Lilly and Company

A Randomized, Double-Blind, Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly Compared to Placebo in Participants With Severe Obesity and Established Cardiovascular Disease

The main purpose of this study is to evaluate the efficacy and safety of retatrutide once weekly in participants with obesity and established cardiovascular disease (CVD). The study will last about 113 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1946

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: There may be multiple sites in this clinical trial -877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • Argentina
    • Buenos Aires
      • Buenos Aires, Buenos Aires, Argentina, C1426ABP
        • Fundacion Respirar
      • CABA, Buenos Aires, Argentina, C1060ABN
        • CEDIC
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1056
        • Centro de Investigaciones Metabólicas (CINME)
      • Ciudad de Buenos Aires, Buenos Aires, Argentina, C1012AAR
        • IDIM - Instituto de Investigaciones Metabólicas
      • Del Viso, Buenos Aires, Argentina, 1669
        • MICA - Medicina e Investigación Cardiometabólica
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Instituto de Investigaciones Clinicas Mar Del Plata
      • Ramos Mejía, Buenos Aires, Argentina, B1704ETD
        • DIM Clinica Privada
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1120AAC
        • Centro Médico Viamonte
      • Buenos Aires, Buenos Aires F.D., Argentina, C1425AGC
        • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
      • Buenos Aires, Buenos Aires F.D., Argentina, 1405
        • Consultorio de Investigacion Clinica EMO SRL
      • Buenos Aires, Buenos Aires F.D., Argentina, C1023AAB
        • STAT Research S.A.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1056ABH
        • Investigaciones Medicas Imoba Srl
    • Córdoba Province
      • Capital, Córdoba Province, Argentina, X5008HHW
        • Centro Médico Privado CEMAIC
      • Córdoba, Córdoba Province, Argentina, 5006
        • Centro Medico Privado San Vicente Diabetes
      • Córdoba, Córdoba Province, Argentina, 5003DCE
        • Instituto Médico DAMIC
    • La Pampa Province
      • Santa Rosa, La Pampa Province, Argentina, 6300
        • Centro de Salud e Investigaciones Médicas
    • Mendoza Province
      • Godoy Cruz, Mendoza Province, Argentina, 5501
        • CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
    • Santa Fe Province
      • Granadero Baigorria, Santa Fe Province, Argentina, 2152
        • Centro de Investigaciones Clinicas Baigorria
      • Rosario, Santa Fe Province, Argentina, 2000
        • Instituto de Investigaciones Clinicas Rosario
      • Rosario, Santa Fe Province, Argentina, 2000
        • INECO Neurociencias Orono
      • Santa Fe, Santa Fe Province, Argentina, S3000FWO
        • Centro de investigaciones Clinicas del Litoral
      • Venado Tuerto, Santa Fe Province, Argentina, 2600
        • Sanatorio San Martin
    • Santiago del Estero Province
      • Santiago del Estero, Santiago del Estero Province, Argentina, 4200
        • Sanatorio Norte
    • Tucumán Province
      • SAN M. de Tucuman, Tucumán Province, Argentina, T4000AXL
        • Centro de Investigaciones Medicas Tucuman
  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 2605
        • Canberra Hospital
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Emeritus Research
      • Brookvale, New South Wales, Australia, 2100
        • Northern Beaches Clinical Research
      • Camden, New South Wales, Australia, 2570
        • Camden Hospital
      • Merewether, New South Wales, Australia, 2291
        • The AIM Centre / Hunter Diabetes Centre
      • Sydney, New South Wales, Australia, 2006
        • University of Sydney - Charles Perkins Centre
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
      • Brisbane, Queensland, Australia, 4064
        • Core Research Group
      • Maroochydore, Queensland, Australia, 4558
        • CDH Research Institute
      • Meadowbrook, Queensland, Australia, 4131
        • Logan Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Fusion Clinical Research
      • Adelaide, South Australia, Australia, 5000
        • Nightingale Research
      • Mount Gambier, South Australia, Australia, 5290
        • Southern Adelaide Diabetes & Endocrine Services
      • Oaklands Park, South Australia, Australia, 5046
        • Southern Adelaide Diabetes & Endocrine Services
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research
      • Geelong, Victoria, Australia, 3220
        • Barwon Health
      • Heidelberg West, Victoria, Australia, 3081
        • Austin Health - Repatriation Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • One Clinical Research
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Y 3W2
        • BC Diabetes Office
      • Victoria, British Columbia, Canada, V8T 5G4
        • Discovery Clinical Services
    • Ontario
      • Cambridge, Ontario, Canada, N3H 4L5
        • Joanne F. Liutkus Medicine Professional Corporation
      • Concord, Ontario, Canada, L4K 4M2
        • LMC Clinical Research Inc. (Thornhill)
      • Hamilton, Ontario, Canada, L8J 0B6
        • Dr. Steven V. Zizzo Research Professional Corporation
      • London, Ontario, Canada, N5W 6A2
        • Milestone Research Inc.
      • North York, Ontario, Canada, M6B 3H7
        • North York Diagnostic and Cardiac Centre
      • Oshawa, Ontario, Canada, L1J 2K9
        • Centricity Research Oshawa
      • Peterborough, Ontario, Canada, K9J 0B2
        • Kawartha Cardiology Clinical Trials
      • Toronto, Ontario, Canada, M9W 4L6
        • Manna Research Toronto
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Ecogene-21
      • Chicoutimi, Quebec, Canada, G7H 0S7
        • Ecogene-21 - Cmas
      • Montreal, Quebec, Canada, H2L 4E9
        • Clinique de médecine Urbaine du Quartier Latin
      • Québec, Quebec, Canada, G1P0A2
        • Syneos Health
      • Saint-Jean-sur-Richelieu, Quebec, Canada, J3A 1J2
        • CardioVasc HR Inc
      • Terrebonne, Quebec, Canada, J6X 4P7
        • Centre de Medecine Metabolique de Lanaudiere (CMML)
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • C.I.C. Mauricie inc.
  • Hungary
    • Budapest
      • Budapest, Budapest, Hungary, 1036
        • Óbudai Egészségügyi Centrum
      • Budapest, Budapest, Hungary, 1089
        • ClinDiab Kft.
      • Budapest, Budapest, Hungary, 1213
        • TRANTOR'99 Bt. Anyagcsere Centrum
    • Csongrád megye
      • Szeged, Csongrád megye, Hungary, 6725
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
    • Debrecen
      • Debrecen, Debrecen, Hungary, 4031
        • Debreceni Egyetem Klinikai Kozpont
    • Fejér
      • Székesfehérvár, Fejér, Hungary, 8000
        • Regia Med Kft
    • Nyíregyháza
      • Nyíregyháza, Nyíregyháza, Hungary, 4400
        • Medifarma 98 Kft
    • Nógrád megye
      • Salgótarján, Nógrád megye, Hungary, 3100
        • Szent Lazar Megyei Korhaz
    • Somogy County
      • Kaposvár, Somogy County, Hungary, 7400
        • Óbudai Egészségügyi Centrum - Kaposvár Site
    • Veszprém megye
      • Balatonfüred, Veszprém megye, Hungary, 8230
        • DRC Gyógyszervizsgáló Központ
    • Zala County
      • Zalaegerszeg, Zala County, Hungary, 8900
        • Zala Megyei Szent Rafael Kórház
    • Zalaegerszeg
      • Zalaegerszeg, Zalaegerszeg, Hungary, 8900
        • Óbudai Egészségügyi Centrum - Zalaegerszeg
  • Mexico
    • Chihuahua
      • Chihuahua City, Chihuahua, Mexico, 31110
        • Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
    • Durango
      • Durango, Durango, Mexico, 34000
        • Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia
    • Estado de Baja California
      • Tijuana, Estado de Baja California, Mexico, 22500
        • Centro de Investigacion Cardiovascular y Metabólica
    • Hidalgo
      • Pachuca, Hidalgo, Mexico, 42084
        • Centro Multidisciplinario de Diabetes de Pachuca
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Unidad de Investigación Clínica y Atención Médica HEPA
      • Zapopan, Jalisco, Mexico, 44260
        • Centro de Investigacion Medica de Occidente, S.C.
    • Mexico City
      • Mexico City, Mexico City, Mexico, 11650
        • Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
      • Mexico City, Mexico City, Mexico, 03100
        • RM Pharma Specialists
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 66460
        • Hospital Universitario "Dr. José Eleuterio González"
      • Monterrey, Nuevo León, Mexico, 64060
        • IMED Internal Medicine Clin Trials
      • Monterrey, Nuevo León, Mexico, 64610
        • Clínica García Flores SC
      • Monterrey, Nuevo León, Mexico, 64718
        • Eukarya PharmaSite
    • San Luis Potosí
      • San Luis Potosí City, San Luis Potosí, Mexico, 78200
        • Centro de atención e investigación cardiovascular del Potosí
    • Veracruz
      • Veracruz, Veracruz, Mexico, 91900
        • FAICIC S. de R.L. de C.V.
    • Yucatán
      • Mérida, Yucatán, Mexico, 97000
        • Eme Red Hospitalaria
      • Mérida, Yucatán, Mexico, 97070
        • Medical Care and Research SA de CV
  • Poland
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-261
        • Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 00-710
        • NBR Polska
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-704
        • KLIMED Marek Klimkiewicz
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-546
        • Centrum Badań Klinicznych PI-House sp. z o.o.
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-081
        • Centrum Medyczne Pratia Katowice
      • Katowice, Silesian Voivodeship, Poland, 40-772
        • NZOZ Salvia CM
      • Zabrze, Silesian Voivodeship, Poland, 41-800
        • Samodzielny Publiczny Szpital Kliniczny nr 1 SUM
    • Warmian-Masurian Voivodeship
      • Elblag, Warmian-Masurian Voivodeship, Poland, 82-300
        • Ambulatorium Sp. z o.o.
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 90338
        • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Ponce Medical School Foundation Inc.
      • Ponce, Puerto Rico, 00717
        • Clinical Research Management Group Inc
      • San Juan, Puerto Rico, 00909
        • Latin Clinical Trial Center
  • Slovakia
      • Bratislava, Slovakia, 831 03
        • MediTask
    • Banská Bystrica Region
      • Lučenec, Banská Bystrica Region, Slovakia, 984 01
        • Nemocnica s poliklinikou Lucenec
    • Bratislava Region
      • Bratislava, Bratislava Region, Slovakia, 811 08
        • Metabol KLINIK
      • Malacky, Bratislava Region, Slovakia, 901 01
        • MediVet s.r.o.
    • Košice Region
      • Košice, Košice Region, Slovakia, 04001
        • Human Care s.r.o.
      • Rožňava, Košice Region, Slovakia, 04801
        • Tatratrial s.r.o.
      • Trebišov, Košice Region, Slovakia, 075 01
        • ARETEUS s.r.o.
    • Presov
      • Sabinov, Presov, Slovakia, 083 01
        • MEDI-DIA s.r.o.
    • Žilina Region
      • Bytča, Žilina Region, Slovakia, 014 01
        • Diab - Int
  • Spain
    • A Coruña [La Coruña]
      • Ferrol, A Coruña [La Coruña], Spain, 15405
        • Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
    • Andalusia
      • Córdoba, Andalusia, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Málaga, Andalusia, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Seville, Andalusia, Spain, 41010
        • Hospital Quiron Infanta Luisa
    • Balears [Baleares]
      • Palma, Balears [Baleares], Spain, 07120
        • Hospital Universitari Son Espases
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Hospital Universitari Vall d'Hebron
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
    • Cádiz
      • Sanlúcar de Barrameda, Cádiz, Spain, 11540
        • Hospital Virgen del Camino
      • Villamartín, Cádiz, Spain, 11650
        • Hospital Virgen de las Montañas
    • Lleida [Lérida]
      • Lleida, Lleida [Lérida], Spain, 25198
        • Hospital Universitario Arnau de Vilanova de Lleida
    • Madrid
      • Madrid, Madrid, Spain, 28009
        • Hospital General Universitario Gregorio Marañon
    • Sevilla
      • Seville, Sevilla, Spain, 41013
        • Hospital Universitario Virgen Del Rocio
      • Seville, Sevilla, Spain, 41950
        • Vithas Hospital Sevilla
    • Valenciana, Comunitat
      • Alzira, Valenciana, Comunitat, Spain, 46600
        • Hospital Universitario de La Ribera
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Central Phoenix Medical Clinic
    • California
      • Covina, California, United States, 91723
        • Valley Clinical Trials, Inc.
      • Fresno, California, United States, 93710
        • Neuro-Pain Medical Center
      • Fresno, California, United States, 93720
        • Valley Research
      • Los Alamitos, California, United States, 90720
        • Collaborative Neuroscience Research, LLC
      • Los Angeles, California, United States, 90057
        • Velocity Clinical Research, Westlake
      • Northridge, California, United States, 91325
        • Valley Clinical Trials, Inc.
      • Van Nuys, California, United States, 91405
        • Velocity Clinical Research, Panorama City
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research, LLC
    • Florida
      • Hialeah, Florida, United States, 33012
        • Indago Research & Health Center, Inc
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc.
      • Orlando, Florida, United States, 32803
        • Charter Research - Winter Park
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Pacific Diabetes & Endocrine Center
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Elite Clinical Trials
      • Boise, Idaho, United States, 83702
        • Humphreys Diabetes Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Gurnee, Illinois, United States, 60031
        • Great Lakes Clinical Trials - Gurnee
      • Springfield, Illinois, United States, 62711
        • Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Brengle Family Medicine
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Iowa Diabetes and Endocrinology Research Center
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Diabetes & Endocrinology
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • MedVadis Research Corporation
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Palm Research Center Tenaya
      • Las Vegas, Nevada, United States, 89128
        • Las Vegas Medical Research
    • New Jersey
      • Warren Township, New Jersey, United States, 07059
        • IMA Clinical Research Warren
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, LLC
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Carteret Medical Group
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Montefiore University Hospital
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Tribe Clinical Research, LLC
      • Myrtle Beach, South Carolina, United States, 29572
        • Trial Management Associates
      • Spartanburg, South Carolina, United States, 29301
        • Tribe Clinical Research - Spartanburg
    • Texas
      • Austin, Texas, United States, 78757
        • Pinnacle Clinical Research
      • Austin, Texas, United States, 78731
        • Texas Diabetes & Endocrinology, P.A.
      • Corpus Christi, Texas, United States, 78404
        • South Texas Clinical Research
      • Mesquite, Texas, United States, 75149
        • Southern Endocrinology Associates
      • Round Rock, Texas, United States, 78681
        • Texas Diabetes & Endocrinology, P.A.
      • San Antonio, Texas, United States, 78229
        • Sleep Therapy Research Center
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research, LLC
    • Utah
      • Ogden, Utah, United States, 84405
        • Advanced Research Institute
    • Washington
      • Renton, Washington, United States, 98057
        • Rainier Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Participants will receive placebo.
Drug: Placebo
Administered SC
Experimental: Retatrutide Dose 1
Participants will receive retatrutide subcutaneously (SC).
Drug: Retatrutide
Administered SC
Other Names:
  • LY3437943
Experimental: Retatrutide Dose 2
Participants will receive retatrutide SC.
Drug: Retatrutide
Administered SC
Other Names:
  • LY3437943

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 80
Baseline, Week 80

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Body Mass Index (BMI)
Time Frame: Baseline, Week 80
Baseline, Week 80
Change from Baseline in Waist Circumference
Time Frame: Baseline, Week 80
Baseline, Week 80
Percent Change from Baseline in Total Cholesterol
Time Frame: Baseline, Week 80
Baseline, Week 80
Percent Change from Baseline in Triglycerides
Time Frame: Baseline, Week 80
Baseline, Week 80
Change from Baseline in Systolic Blood Pressure (SBP)
Time Frame: Baseline, Week 80
Baseline, Week 80
Change from Baseline in Diastolic Blood Pressure (DBP)
Time Frame: Baseline, Week 80
Baseline, Week 80
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 80
Baseline, Week 80
Percent Change from Baseline in Fasting Insulin
Time Frame: Baseline, Week 80
Baseline, Week 80
Change from Baseline in Short Form version 2 (SF-36v2) Acute Form Physical Function Domain Score
Time Frame: Baseline, Week 80
Baseline, Week 80
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Cure (AUC)
Time Frame: Baseline to Week 80
AUC is presented as a single average measure of AUC across the study duration.
Baseline to Week 80

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 16, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 14, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18582
  • J1I-MC-GZBM (Other Identifier: Eli Lilly and Company)
  • 2023-503659-88-00 (Other Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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