A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight

NCT ID: NCT05929066

Last Updated: 2025-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

2300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-10

Study Completion Date

2026-05-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits. Addendum (2) is optional and available to approximately 500 participants to continue treatment with retatrutide for up to an additional 24 weeks.

Detailed Description

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Conditions

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Obesity Overweight Osteoarthritis, Knee Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Retatrutide Dose 1

Participants will receive retatrutide subcutaneously (SC).

Group Type EXPERIMENTAL

Retatrutide

Intervention Type DRUG

Administered SC

Retatrutide Dose 2

Participants will receive retatrutide SC.

Group Type EXPERIMENTAL

Retatrutide

Intervention Type DRUG

Administered SC

Retatrutide Dose 3

Participants will receive retatrutide SC.

Group Type EXPERIMENTAL

Retatrutide

Intervention Type DRUG

Administered SC

Placebo

Participants will receive placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Retatrutide Extension Period

Participants will receive retatrutide after the placebo-controlled 80 week treatment period for an additional 24 weeks.

Group Type EXPERIMENTAL

Retatrutide

Intervention Type DRUG

Administered SC

Interventions

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Retatrutide

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY3437943

Eligibility Criteria

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Inclusion Criteria

* Have body mass index (BMI) ≥30.0 kilograms per square meter (kg/m²), or ≥27.0 kg/m² with at least one of the following:

* hypertension
* dyslipidemia
* obstructive sleep apnea, or
* cardiovascular disease
* History of of at least one unsuccessful dietary effort to reduce body weight


* Have index knee pain for \>12 weeks prior to screening, and presence of index knee pain for \>15 days over the previous month
* Have knee X-ray with moderate radiographic changes (Kellgren-Lawrence Grade 2 or 3) per central reading at screening
* Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA.


* Previously diagnosed with OSA
* Have AHI ≥15 on polysomnography at screening (definition of moderate-to-severe OSA)
* For participants not on positive airway pressure (PAP) therapy: unable or unwilling to use PAP therapy and have not used PAP for at least 4 weeks prior to screening.
* If on PAP therapy, have been on PAP therapy for at least 3 consecutive months prior to screening, and willing to temporarily stop using PAP therapy for approximately 7 days prior to each of the sleep study (PSG) visits.


* Have completed the final treatment visit of GZBJ Week 80.

Exclusion Criteria

* Have a self-reported or documented change in body weight \>5 kg (11 pounds) within 90 days.
* Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
* Have a prior or planned surgical treatment for obesity.
* Have diabetes mellitus.
* Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* Have had pancreatitis.


* Have had steroid joint injections within 90 days of screening.
* Have had other joint injections and procedures within 6 months of screening.
* Have joint disease other than osteoarthritis.


* Use stimulants (for example, modafinil, armodafinil, solriamfetol, pitolisant, amphetamine) less than 3 months prior to screening.
* Use hypnotics, mirtazapine, opioids, trazodone, and zonisamide less than 3 months prior to screening.
* Use a dental appliance or other device to treat OSA other than PAP therapy.


* Have had study intervention discontinuation.
* Have had permanent dose reduction.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Central Phoenix Medical Clinic

Phoenix, Arizona, United States

Site Status

Arizona Research Center

Phoenix, Arizona, United States

Site Status

Medical Investigations

Little Rock, Arkansas, United States

Site Status

Neuro-Pain Medical Center

Fresno, California, United States

Site Status

Valley Research

Fresno, California, United States

Site Status

Artemis Institute for Clinical Research

San Diego, California, United States

Site Status

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Chase Medical Research, LLC

Waterbury, Connecticut, United States

Site Status

Teradan Clinical Trials, LLC

Brandon, Florida, United States

Site Status

Suncoast Research Group

Miami, Florida, United States

Site Status

New Horizon Research Center

Miami, Florida, United States

Site Status

Clinical Neuroscience Solutions

Orlando, Florida, United States

Site Status

Progressive Medical Research

Port Orange, Florida, United States

Site Status

NeuroTrials Research Inc

Atlanta, Georgia, United States

Site Status

North Georgia Clinical Research

Woodstock, Georgia, United States

Site Status

East-West Medical Research Institute

Honolulu, Hawaii, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative

Springfield, Illinois, United States

Site Status

Brengle Family Medicine

Indianapolis, Indiana, United States

Site Status

Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, United States

Site Status

MedVadis Research Corporation

Waltham, Massachusetts, United States

Site Status

Great Lakes Research Group, Inc.

Bay City, Michigan, United States

Site Status

StudyMetrix Research

City of Saint Peters, Missouri, United States

Site Status

Clinvest Research LLC

Springfield, Missouri, United States

Site Status

Palm Research Center Tenaya

Las Vegas, Nevada, United States

Site Status

Rochester Clinical Research, LLC

Rochester, New York, United States

Site Status

Carteret Medical Group

Morehead City, North Carolina, United States

Site Status

Trial Management Associates - Wilmington - Floral Parkway

Wilmington, North Carolina, United States

Site Status

Lillestol Research

Fargo, North Dakota, United States

Site Status

Altoona Center For Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Tribe Clinical Research, LLC

Greenville, South Carolina, United States

Site Status

Tribe Clinical Research - Spartanburg

Spartanburg, South Carolina, United States

Site Status

Vanderbilt Health One Hundred Oaks

Nashville, Tennessee, United States

Site Status

FutureSearch Trials of Neurology

Austin, Texas, United States

Site Status

Juno Research

Houston, Texas, United States

Site Status

Advanced Research Institute

Ogden, Utah, United States

Site Status

Northwest Clinical Research Center

Bellevue, Washington, United States

Site Status

Rainier Clinical Research Center

Renton, Washington, United States

Site Status

Emeritus Research

Botany, New South Wales, Australia

Site Status

The AIM Centre / Hunter Diabetes Centre

Merewether, New South Wales, Australia

Site Status

Logan Hospital

Meadowbrook, Queensland, Australia

Site Status

Fusion Clinical Research

Adelaide, South Australia, Australia

Site Status

Nightingale Research

Adelaide, South Aust, Australia

Site Status

Emeritus Research

Camberwell, Victoria, Australia

Site Status

Barwon Health

Geelong, Victoria, Australia

Site Status

One Clinical Research

Nedlands, Western Australia, Australia

Site Status

CPCLIN

São Paulo, São Paulo, Brazil

Site Status

CPQuali Pesquisa Clínica

São Paulo, , Brazil

Site Status

CEPIC - Centro Paulista de Investigação Clínica

São Paulo, , Brazil

Site Status

Aggarwal and Associates Limited

Brampton, Ontario, Canada

Site Status

Dr. Steven V. Zizzo Medicine Professional Corporation

Hamilton, Ontario, Canada

Site Status

Wharton Medical Clinic

Hamilton, Ontario, Canada

Site Status

Your Research Network

Niagara Falls, Ontario, Canada

Site Status

Bluewater Clinical Research Group Inc.

Sarnia, Ontario, Canada

Site Status

Canadian Phase Onward

Toronto, Ontario, Canada

Site Status

Centre de Recherche Clinique de Laval

Laval, Quebec, Canada

Site Status

Clinique de médecine Urbaine du Quartier Latin

Montreal, Quebec, Canada

Site Status

C.I.C. Mauricie inc.

Trois-Rivières, Quebec, Canada

Site Status

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

Szeged, Csongrád megye, Hungary

Site Status

Regia Med Kft

Székesfehérvár, Fejér, Hungary

Site Status

Medifarma 98 Kft

Nyíregyháza, Nyíregyháza, Hungary

Site Status

DRC Gyógyszervizsgáló Központ

Balatonfüred, Veszprém megye, Hungary

Site Status

Óbudai Egészségügyi Centrum

Budapest, , Hungary

Site Status

ClinDiab Kft.

Budapest, , Hungary

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Debreceni Egyetem Klinikai Központ

Debrecen, , Hungary

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Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

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Endolife Speciality Hospitals

Guntur, Andhra Pradesh, India

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Avron Hospitals

Ahmedabad, Gujarat, India

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Surat Institute of Digestive Sciences Hospitals

Surat, Gujarat, India

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Karnataka Institute of Medical Sciences

Hubli, Karnataka, India

Site Status

Indian Institute of Diabetes

Thiruvananthapuram, Kerala, India

Site Status

Jothydev's Diabetes and Research Center

Trivandrum, Kerala, India

Site Status

Wockhardt Hospital - Mumbai Central

Mumbai, Maharashtra, India

Site Status

Deenanath Mangeshkar Hospital & Research Centre

Pune, Maharashtra, India

Site Status

Chellaram Diabetes Institute

Pune, Maharashtra, India

Site Status

Lifepoint Multispeciality Hospital

Pune, Maharashtra, India

Site Status

All India Institute of Medical Sciences

Bhubaneswar, Odisha, India

Site Status

Eternal Heart Care Center and Research Institute

Jaipur, Rajasthan, India

Site Status

Christian Medical College Vellore

Vellore, Tamil Nadu, India

Site Status

ILS Hospitals

Kolkata, West Benga, India

Site Status

Centro de Investigacion en Artritis y Osteoporosis SC

Mexicali, Estado de Baja California, Mexico

Site Status

Diseno y Planeacion en Investigacion Medica

Guadalajara, Jalisco, Mexico

Site Status

Clinica de Investigacion en Reumatologia y Obesidad S. C.

Guadalajara, Jalisco, Mexico

Site Status

Private Practice - Dr. Arechavaleta Granell Maria del Rosario

Guadalajara, Jalisco, Mexico

Site Status

Unidad de Investigación Clínica y Atención Médica HEPA

Guadalajara, Jalisco, Mexico

Site Status

RM Pharma Specialists

Mexico City, Mexico City, Mexico

Site Status

Clinica Omega

Mexico City, Mexico City, Mexico

Site Status

Instituto de Diabetes, Obesidad y Nutricion

Cuernavaca, Morelos, Mexico

Site Status

Unidad biomedica avanzada monterrey

Monterrey, Nuevo León, Mexico

Site Status

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León, Mexico

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EME RED Hospitalaria

Mérida, Yucatán, Mexico

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Kohler and Milstein Research S.A. de C.V.

Mérida, Yucatán, Mexico

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Centro de Atención e Investigación Clínica

Aguascalientes, , Mexico

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Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos

Chihuahua City, , Mexico

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Arké SMO S.A de C.V

Veracruz, , Mexico

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Centrum Zdrowia Metabolicznego Pawel Bogdanski

Poznan, Greater Poland Voivodeship, Poland

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INTERCOR

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

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Private Practice - Dr. Robert Witek

Tarnów, Lesser Poland Voivodeship, Poland

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CenterMed Lublin NZOZ

Lublin, Lublin Voivodeship, Poland

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Gabinety TERPA

Lublin, Lublin Voivodeship, Poland

Site Status

MICS Centrum Medyczne Warszawa

Warsaw, Masovian Voivodeship, Poland

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Uniwersytecki Szpital Kliniczny w Białymstoku

Bialystok, Podlaskie Voivodeship, Poland

Site Status

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Pomeranian Voivodeship, Poland

Site Status

NZOZ Salvia CM

Katowice, Silesian Voivodeship, Poland

Site Status

Ambulatorium Sp. z o.o.

Elblag, Warmian-Masurian Voivodeship, Poland

Site Status

Centrum Kliniczno-Badawcze

Elblag, Warmian-Masurian Voivodeship, Poland

Site Status

Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otylosci

Kielce, Świętokrzyskie Voivodeship, Poland

Site Status

Ponce Medical School Foundation Inc.

Ponce, , Puerto Rico

Site Status

Diabdana

Oradea, Bihor County, Romania

Site Status

C.M.D.T.A. Neomed

Brasov, Brașov County, Romania

Site Status

Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului

Bucharest, București, Romania

Site Status

Gama Diamed

Mangalia, Constanța County, Romania

Site Status

Cabinet Medical Dr.Geru

Timișoara, Timiș County, Romania

Site Status

SC Minimed SRL

Bacau, , Romania

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Diamed Obesity

Galați, , Romania

Site Status

Centrul Medical Consultmed

Iași, , Romania

Site Status

Clinica Korall

Satu Mare, , Romania

Site Status

Policlinica Astra Sibiu

Sibiu, , Romania

Site Status

CHUAC-Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña [La Coruña], Spain

Site Status

Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval

Ferrol, A Coruña [La Coruña], Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], Spain

Site Status

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Site Status

Hospital General Universitario de Valencia

Valencia, Valenciana, Comunitat, Spain

Site Status

Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

Seville, , Spain

Site Status

Rowden Surgery

Chippenham, England, United Kingdom

Site Status

Layton Medical Centre

Blackpool, Lancashire, United Kingdom

Site Status

Leicester General Hospital

Leicester, Leicestershire, United Kingdom

Site Status

Panthera Biopartners - North London

Enfield, London, City of, United Kingdom

Site Status

Glasgow Royal Infirmary

Glasgow, Scotland, United Kingdom

Site Status

Heartlands Hospital

Birmingham, , United Kingdom

Site Status

Aintree University Hospital NHS Foundation Trust

Liverpool, , United Kingdom

Site Status

St Clare Medical Centre

Penzance, , United Kingdom

Site Status

Panthera Biopartners - Sheffield

Sheffield, , United Kingdom

Site Status

Countries

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United States Australia Brazil Canada Hungary India Mexico Poland Puerto Rico Romania Spain United Kingdom

Related Links

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https://trials.lilly.com/en-US/trial/408235

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight (TRIUMPH-1)

Other Identifiers

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J1I-MC-GZBJ

Identifier Type: OTHER

Identifier Source: secondary_id

J1I-MC-GOA1

Identifier Type: OTHER

Identifier Source: secondary_id

J1I-MC-GSA1

Identifier Type: OTHER

Identifier Source: secondary_id

2023-503657-35-00

Identifier Type: OTHER

Identifier Source: secondary_id

18557

Identifier Type: -

Identifier Source: org_study_id

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