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NCT05929066 | RECRUITING | Obesity


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

Eli Lilly and Company

Brief Summary:

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.

Condition or disease

Obesity

Overweight

Knee Pain Chronic

Knee Osteoarthritis

Obstructive Sleep Apnea

Intervention/treatment

Retatrutide

Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 2100 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (TRIUMPH-1)
Actual Study Start Date : 2023-07-10
Estimated Primary Completion Date : 2026-04-15
Estimated Study Completion Date : 2026-05-13

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
    • GOA1 Inclusion Criteria
      • * 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.
      • GSA1 Inclusion Criteria
        • * Previously diagnosed with OSA
        • * Have AHI ≥15 on polysomnography at screening (definition of moderate-to-severe OS)
        • * 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.
        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.
        • GOA1 exclusion criteria
        • * 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.
        • GSA1 exclusion criteria
        • * 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.

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

Location Details

NCT05929066


Please Choose a site



How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

United States, Arizona

Central Phoenix Medical Clinic

Phoenix, arizona, United States, 85020

RECRUITING

United States, Arizona

Arizona Research Center

Phoenix, arizona, United States, 85053

RECRUITING

United States, Arkansas

Medical Investigations

Little Rock, arkansas, United States, 72211

RECRUITING

United States, California

Valley Research

Fresno, California, United States, 93720

RECRUITING

United States, California

Artemis Institute for Clinical Research

San Diego, California, United States, 92103

RECRUITING

United States, Colorado

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

RECRUITING

United States, Connecticut

Yale University School of Medicine

New Haven, Connecticut, United States, 06519

RECRUITING

United States, Connecticut

Chase Medical Research, LLC

Waterbury, Connecticut, United States, 06708

RECRUITING

United States, Florida

Teradan Clinical Trials, LLC

Brandon, Florida, United States, 33511

RECRUITING

United States, Florida

Suncoast Research Group

Miami, Florida, United States, 33135

RECRUITING

United States, Florida

New Horizon Research Center

Miami, Florida, United States, 33165

RECRUITING

United States, Florida

Clinical Neuroscience Solutions

Orlando, Florida, United States, 32801

RECRUITING

United States, Florida

Progressive Medical Research

Port Orange, Florida, United States, 32127

RECRUITING

United States, Georgia

NeuroTrials Research Inc

Atlanta, Georgia, United States, 30328

RECRUITING

United States, Georgia

North Georgia Clinical Research

Woodstock, Georgia, United States, 30189

RECRUITING

United States, Hawaii

East-West Medical Research Institute

Honolulu, Hawaii, United States, 96814

RECRUITING

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

RECRUITING

United States, Illinois

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

Springfield, Illinois, United States, 62711

RECRUITING

United States, Indiana

Brengle Family Medicine

Indianapolis, Indiana, United States, 46260

RECRUITING

United States, Kansas

Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, United States, 66606

RECRUITING

United States, Massachusetts

MedVadis Research Corporation

Waltham, Massachusetts, United States, 02451

RECRUITING

United States, Michigan

Great Lakes Research Group, Inc.

Bay City, Michigan, United States, 48706

RECRUITING

United States, Missouri

StudyMetrix Research

Saint Peters, Missouri, United States, 63303

RECRUITING

United States, Missouri

Clinvest Research LLC

Springfield, Missouri, United States, 65807

RECRUITING

United States, Nevada

Palm Research Center Tenaya

Las Vegas, Nevada, United States, 89128

RECRUITING

United States, New York

Rochester Clinical Research, LLC

Rochester, New York, United States, 14609

RECRUITING

United States, North Carolina

Carteret Medical Group

Morehead City, North Carolina, United States, 28557

RECRUITING

United States, North Carolina

Trial Management Associates - Wilmington - Floral Parkway

Wilmington, North Carolina, United States, 28403

RECRUITING

United States, North Dakota

Lillestol Research

Fargo, North Dakota, United States, 58104

RECRUITING

United States, Pennsylvania

Altoona Center For Clinical Research

Duncansville, Pennsylvania, United States, 16635

RECRUITING

United States, South Carolina

Tribe Clinical Research, LLC

Greenville, South Carolina, United States, 29607

RECRUITING

United States, South Carolina

Tribe Clinical Research - Spartanburg

Spartanburg, South Carolina, United States, 29301

RECRUITING

United States, Tennessee

Vanderbilt Health One Hundred Oaks

Nashville, Tennessee, United States, 37204

RECRUITING

United States, Texas

FutureSearch Trials of Neurology

Austin, Texas, United States, 78731

RECRUITING

United States, Texas

Juno Research

Houston, Texas, United States, 77040

RECRUITING

United States, Utah

Advanced Research Institute

Ogden, Utah, United States, 84405

RECRUITING

United States, Washington

Northwest Clinical Research Center

Bellevue, Washington, United States, 98007

RECRUITING

United States, Washington

Rainier Clinical Research Center

Renton, Washington, United States, 98057

RECRUITING

Australia, New South Wales

Emeritus Research

Botany, New South Wales, Australia, 2019

RECRUITING

Australia, New South Wales

The AIM Centre / Hunter Diabetes Centre

Merewether, New South Wales, Australia, 2291

RECRUITING

Australia, Queensland

Logan Hospital

Meadowbrook, Queensland, Australia, 4131

RECRUITING

Australia, South Australia

Fusion Clinical Research

Adelaide, South Australia, Australia, 5000

RECRUITING

Australia, South Australia

Nightingale Research

Adelaide, South Australia, Australia, 5000

RECRUITING

Australia, Victoria

Emeritus Research

Camberwell, Victoria, Australia, 3124

RECRUITING

Australia, Victoria

Barwon Health

Geelong, Victoria, Australia, 3220

RECRUITING

Australia, Western Australia

One Clinical Research

Nedlands, Western Australia, Australia, 6009

RECRUITING

Brazil, São Paulo

CPCLIN

São Paulo, São Paulo, Brazil, 01228-200

RECRUITING

Brazil,

CPQuali Clinical Research

São Paulo, Brazil, 01228-000

RECRUITING

Brazil,

CEPIC - São Paulo Center for Clinical Research

São Paulo, Brazil, 04266-010

RECRUITING

Canada, Ontario

Aggarwal and Associates Limited

Brampton, Ontario, Canada, L6T 0G1

RECRUITING

Canada, Ontario

Dr. Steven V. Zizzo Medicine Professional Corporation

Hamilton, Ontario, Canada, L8J 0B6

RECRUITING

Canada, Ontario

Wharton Medical Clinic

Hamilton, Ontario, Canada, L8L 5G8

RECRUITING

Canada, Ontario

Your Research Network

Niagara Falls, Ontario, Canada, L2H 1H5

RECRUITING

Canada, Ontario

Bluewater Clinical Research Group Inc.

Sarnia, Ontario, Canada, N7T 4X3

RECRUITING

Canada, Ontario

Canadian Phase Onward

Toronto, Ontario, Canada, oe3h 0k2

RECRUITING

Canada, Quebec

Laval Clinical Research Center

Laval, Quebec, Canada, I'm going to scold

RECRUITING

Canada, Quebec

Latin Quarter Urban Medicine Clinic

Montreal, Quebec, Canada, H2L 4E9

RECRUITING

Canada, Quebec

C.I.C. Mauricie inc.

Trois-Rivières, Quebec, Canada, G8T 7A1

ACTIVE NOT RECRUITING

Hungary, Csongrad

University of Szeged Szent-Györgyi Albert Clinical Center

Szeged, Csongrad, Hungary, 6725

ACTIVE NOT RECRUITING

Hungary, Head

Regia Med Kft

Szekesfehervar, head, Hungary, 8000

ACTIVE NOT RECRUITING

Hungary, Nyíregyháza

Medifarma 98 Kft

Nyiregyhaza, Nyíregyháza, Hungary, 4400

ACTIVE NOT RECRUITING

Hungary, Veszprém

DRC Drug Testing Center

Balatonfüred, Veszprém, Hungary, 8230

ACTIVE NOT RECRUITING

Hungary,

Óbuda Health Center

Budapest, Hungary, 1036

ACTIVE NOT RECRUITING

Hungary,

ClinDiab Kft.

Budapest, Hungary, 1089

ACTIVE NOT RECRUITING

Hungary,

University of Debrecen - Gyula Kenézy University Teaching Hospital

Debrecen, Hungary, 4031

ACTIVE NOT RECRUITING

Hungary,

University of Debrecen Clinical Center

Debrecen, Hungary, 4032

RECRUITING

India, Andhra Pradesh

Endolife Speciality Hospitals

Guntur, Andhra Pradesh, India, 522001

RECRUITING

India, Gujarat

Avron Hospitals

Ahmedabad, Gujarat, India, 380013

RECRUITING

India, Gujarat

Surat Institute of Digestive Sciences Hospitals

Surat, Gujarat, India, 395002

RECRUITING

India, Karnataka

Karnataka Institute of Medical Sciences

Hubli, Karnataka, India, 580021

RECRUITING

India, Kerala

Indian Institute of Diabetes

Thiruvananthapuram, Kerala, India, 695031

RECRUITING

India, Kerala

Jothydev's Diabetes and Research Center

Trivandrum, Kerala, India, 695032

RECRUITING

India, Maharashtra

Wockhardt Hospital - Mumbai Central

Mumbai, Maharashtra, India, 400011

RECRUITING

India, Maharashtra

Deenanath Mangeshkar Hospital & Research Centre

Pune, Maharashtra, India, 411004

RECRUITING

India, Maharashtra

Chellaram Diabetes Institute

Pune, Maharashtra, India, 411021

RECRUITING

India, Maharashtra

Lifepoint Multispeciality Hospital

Pune, Maharashtra, India, 411057

RECRUITING

India, Odisha

All India Institute of Medical Sciences

Bhubaneswar, Odisha, India, 751019

RECRUITING

India, Rajasthan

Eternal Heart Care Center and Research Institute

Jaipur, Rajasthan, India, 302020

RECRUITING

India, Tamil Nadu

Christian Medical College Vellore

Vellore, tamil nadu, India, 632004

RECRUITING

India, West Bengal

ILS Hospitals

Kolkata, West Bengal, India, 700064

RECRUITING

Mexico, Baja California

Arthritis and Osteoporosis Research Center SC

Mexicali, Baja California, Mexico, 21200

RECRUITING

Mexico, Federal District

RM Pharma Specialists

Mexico City, Federal District, Mexico, 03100

RECRUITING

Mexico, Federal District

Omega Clinic

Mexico City, Federal District, Mexico, 06700

RECRUITING

Mexico, Jalisco

Design and Planning in Medical Research

Guadalajara, Jalisco, Mexico, 44130

RECRUITING

Mexico, Jalisco

Research Clinic in Rheumatology and Obesity S. C.

Guadalajara, Jalisco, Mexico, 44650

RECRUITING

Mexico, Jalisco

Private Practice - Dr. Arechavaleta Granell Maria del Rosario

Guadalajara, Jalisco, Mexico, 44670

RECRUITING

Mexico, Jalisco

HEPA Clinical Research and Healthcare Unit

Guadalajara, Jalisco, Mexico, 44670

RECRUITING

Mexico, Morelos

Institute of Diabetes, Obesity and Nutrition

Cuernavaca, Morelos, Mexico, 62250

RECRUITING

Mexico, New Lion

Monterrey advanced biomedical unit

Monterrey, New Lion, Mexico, 64460

RECRUITING

Mexico, New Lion

Dr. Jose Eleuterio Gonzalez University Hospital

Monterrey, New Lion, Mexico, 66460

RECRUITING

Mexico, Yucatan

EME Hospital Network

Merida, Yucatan, Mexico, 97000

RECRUITING

Mexico, Yucatan

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

Merida, Yucatan, Mexico, 97070

RECRUITING

Mexico,

Clinical Care and Research Center

Aguascalientes, Mexico, 20119

RECRUITING

Mexico,

Research in Health and Metabolism S.C / Clinical Nutrition / Database Unit

Chihuahua, Mexico, 31110

RECRUITING

Mexico,

Arké SMO S.A. de C.V

Veracruz, Mexico, 91910

RECRUITING

Poland, Kuyavian-Pomeranian Voivodeship

INTERCOR

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-605

RECRUITING

Poland, Lubelskie

CenterMed Lublin NZOZ

Lublin, Lubelskie, Poland, 20-044

RECRUITING

Poland, Lubelskie

TERPA offices

Lublin, Lubelskie, Poland, 20-333

RECRUITING

Poland, Masovian Voivodeship

Clinical Medicine

Warsaw, Masovian Voivodeship, Poland, 00-874

RECRUITING

Poland, Lesser Poland Voivodeship

Private Practice - Dr. Robert Witek

Tarnów, Małopolskie, Poland, 33-100

RECRUITING

Poland, Podlasie

University Clinical Hospital in Białystok

Białystok, Podlasie, Poland, 15-276

RECRUITING

Poland, Pomeranian Voivodeship

PI-House Clinical Research Center sp. z o. o.

Gdansk, Pomeranian Voivodeship, Poland, 80-546

RECRUITING

Poland, Warmian-Masurian Voivodeship

Clinical and Research Center

Go away, Warmian-Masurian Voivodeship, Poland, 82-300

RECRUITING

Poland, Warmian-Masurian Voivodeship

Barbara Bazela Outpatient Clinic

Elbląg, Warmian-Masurian Voivodeship, Poland, 82-300

RECRUITING

Poland, Greater Poland

Pawel Bogdanski Metabolic Health Center

Poznań, Greater Poland, Poland, 60-589

RECRUITING

Poland, Silesian

NZOZ Salvia CM

Katowice, Silesian, Poland, 40-772

RECRUITING

Poland, Świętokrzyskie

Specialized Medical Practice Diabetology, Treatment of Diabetes and Obesity

Kielce, Świętokrzyskie, Poland, 25-355

RECRUITING

Puerto Rico,

Ponce Medical School Foundation Inc.

Ponce, Puerto Rico, 00716

RECRUITING

Romania, Bihor

Diabdana

Oradea city, Bihor, Romania, 410147

RECRUITING

Romania, Braşov

C.M.D.T.A. Neomed

Brasov, Brasov, Romania, 500283

RECRUITING

Romania, Bucharest

Hightech Medical Services SRL-Center for the Study of Metabolism

Bucharest, Bucharest, Romania, 011053

RECRUITING

Romania, Constant

Gama Diamed

mangalore, Constant, Romania, 905500

RECRUITING

Romania, Timis

Cabinet Medical Dr.Geru

Timisoara, Timiş, Romania, 300288

RECRUITING

Romania,

SC Minimed SRL

Bacau, Romania, 600274

RECRUITING

Romania,

Diamed Obesity

Galati, Romania, 800291

RECRUITING

Romania,

Consultmed Medical Center

IASI, Romania, 700547

RECRUITING

Romania,

Clinica Korall

One Mare, Romania, 440055

RECRUITING

Romania,

Astra Sibiu Polyclinic

Sibiu, Romania, 550371

ACTIVE NOT RECRUITING

Spain, A Coruña [La Coruña]

CHUAC-Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña [La Coruña], Spain, 15006

ACTIVE NOT RECRUITING

Spain, A Coruña [La Coruña]

Ferrol University Hospital Complex (CHUF)- Naval Hospital

Ferrol, A Coruña [La Coruña], Spain, 15405

ACTIVE NOT RECRUITING

Spain, Barcelona [Barcelona]

Vall d'Hebron University Hospital

Barcelona, Barcelona [Barcelona], Spain, 08035

ACTIVE NOT RECRUITING

Spain, Cantabria

Marqués de Valdecilla University Hospital

Santander, Cantabria, Spain, 39008

COMPLETED

Spain, Valenciana, Community

General University Hospital of Valencia

Valencia, Valencian Community, Spain, 46014

ACTIVE NOT RECRUITING

Spain,

New Technologies in Diabetes and Endocrinology Clinic (NTDE)

Sevilla, Spain, 41003

RECRUITING

United Kingdom, England

Rowden Surgery

Chippenham, England, United Kingdom, SN15 2SB

RECRUITING

United Kingdom, Lancashire

Layton Medical Centre

Blackpool, Lancashire, United Kingdom, Once in a while

RECRUITING

United Kingdom, Leicestershire

Leicester General Hospital

Leicester, Leicestershire, United Kingdom, LE5 4PW

RECRUITING

United Kingdom, London, City Of

Panthera Biopartners - North London

Enfield, London, City Of, United Kingdom, EN3 4GS

RECRUITING

United Kingdom, Scotland

Glasgow Royal Infirmary

Glasgow, Scotland, United Kingdom, G31 2ER

RECRUITING

United Kingdom,

Heartlands Hospital

Birmingham, United Kingdom, B9 5SS

RECRUITING

United Kingdom,

Aintree University Hospital NHS Foundation Trust

Liverpool, United Kingdom, A thief in a situation

RECRUITING

United Kingdom,

St Clare Medical Centre

Penzance, United Kingdom, TR18 3DX

RECRUITING

United Kingdom,

Panthera Biopartners - Sheffield

Sheffield, United Kingdom, S2 5FX

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