A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss

Last updated: May 21, 2024
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Weight Loss

Diabetes Prevention

Obesity

Treatment

Tirzepatide

Placebo

Clinical Study ID

NCT04660643
17247
I8F-MC-GPHN
  • Ages > 18
  • All Genders

Study Summary

This was a study of tirzepatide in participants with obesity or overweight. The main purpose was to learn more about how tirzepatide maintained body weight loss. The study had two phases: a lead-in phase in which all participants took tirzepatide and a treatment phase in which participants either continued tirzepatide or switched to placebo. The study lasted about 2 years (25 visits).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body Mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² andprevious diagnosis with at least one of the following comorbidities: hypertension,dyslipidemia, obstructive sleep apnea, cardiovascular disease

  • History of at least one unsuccessful dietary effort to lose body weight

Exclusion

Exclusion Criteria:

  • Diabetes mellitus

  • Change in body weight greater than 5 kg within 3 months prior to starting study

  • Obesity induced by other endocrinologic disorders or monogenetic or syndromic formsof obesity

  • History of pancreatitis

  • Family or personal history of medullary thyroid carcinoma (MTC) or multipleendocrine neoplasia syndrome type 2 (MEN-2)

  • History of significant active or unstable major depressive disorder (MDD) or othersevere psychiatric disorder within the last 2 years

  • Any lifetime history of a suicide attempt

Study Design

Total Participants: 783
Treatment Group(s): 2
Primary Treatment: Tirzepatide
Phase: 3
Study Start date:
March 29, 2021
Estimated Completion Date:
May 18, 2023

Connect with a study center

  • CEDIC

    Caba, Buenos Aires C1060ABN
    Argentina

    Site Not Available

  • Centro Médico Viamonte

    Caba, Buenos Aires C1120AAC
    Argentina

    Site Not Available

  • Stat Research S.A.

    Ciudad Autónoma de Buenos Aire, Buenos Aires C1023AAB
    Argentina

    Site Not Available

  • Mautalen Salud e Investigación

    Buenos Aires, Ciudad Autónoma De Buenos Aire C1128AAF
    Argentina

    Site Not Available

  • Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada

    Ciudad Autonoma de Buenos Aire, Ciudad Autónoma De Buenos Aire C1425AGC
    Argentina

    Site Not Available

  • Instituto Médico Catamarca IMEC

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Asociación de Beneficencia Hospital Sirio Libanés

    Buenos Aires, C1419AHN
    Argentina

    Site Not Available

  • CEDOES

    Vitória, Espírito Santo 29055450
    Brazil

    Site Not Available

  • Cline Research Center

    Curitiba, Paraná 80030-480
    Brazil

    Site Not Available

  • Núcleo de Pesquisa Clínica do Rio Grande do Sul

    Porto Alegre, Rio Grande Do Sul 90430-001
    Brazil

    Site Not Available

  • Centro de Pesquisa Sao Lucas

    Campinas, São Paulo 13034-685
    Brazil

    Site Not Available

  • BR Trials - Ensaios Clinicos e Consultoria

    Sao Paulo, São Paulo 03325-050
    Brazil

    Site Not Available

  • ISPEM - Instituto São José dos Campos em Pesquisas Médicas

    São José dos Campos, São Paulo 12243-280
    Brazil

    Site Not Available

  • IBPClin - Instituto Brasil de Pesquisa Clínica

    Rio de Janeiro, 22241-180
    Brazil

    Site Not Available

  • CPQuali Pesquisa Clínica

    São Paulo, 01228-000
    Brazil

    Site Not Available

  • Hospital Universitario Dr. José Eleuterio González, Universidad Autónoma de Nuevo León

    Monterrey, Nuevo León 66460
    Mexico

    Site Not Available

  • Investigacion En Salud Y Metabolismo Sc

    Chihuahua, 31217
    Mexico

    Site Not Available

  • Centro de Endocrinologia Alcantara Gonzalez

    Bayamon, 00959
    Puerto Rico

    Site Not Available

  • Private Practice Dr. Martha Gomez Cuellar

    San Juan, 00921
    Puerto Rico

    Site Not Available

  • Wellness clinical Research Vega Baja

    Vega Baja, 00694
    Puerto Rico

    Site Not Available

  • Chung Shan Medical University Hospital

    Taichung City, Taichung 402
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung, 40447
    Taiwan

    Site Not Available

  • Chung Shan Medical University Hospital

    Taichung, 402
    Taiwan

    Site Not Available

  • National Cheng-Kung Uni. Hosp.

    Tainan, 704
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • Cahaba Research

    Pelham, Alabama 35124
    United States

    Site Not Available

  • Scripps Memorial Hospital La Jolla

    La Jolla, California 92037
    United States

    Site Not Available

  • National Research Institute - Wilshire

    Los Angeles, California 90057
    United States

    Site Not Available

  • National Research Institute

    Panorama City, California 91402
    United States

    Site Not Available

  • Artemis Institute for Clinical Research

    San Diego, California 92103
    United States

    Site Not Available

  • University Clinical Investigators, Inc.

    Tustin, California 92780
    United States

    Site Not Available

  • New West Physicians Clinical Research

    Golden, Colorado 80401
    United States

    Site Not Available

  • Optumcare Colorado Springs - Monument

    Monument, Colorado 80132
    United States

    Site Not Available

  • Care Partners Clinical Research

    Jacksonville, Florida 32277
    United States

    Site Not Available

  • South Florida Clinical Research Institute

    Margate, Florida 33063
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Site Not Available

  • ForCare Clinical Research

    Tampa, Florida 33613
    United States

    Site Not Available

  • Endocrine Research Solutions, Inc.

    Roswell, Georgia 30076
    United States

    Site Not Available

  • SKY Clinical Research Network Group-Blake

    Union City, Georgia 30291
    United States

    Site Not Available

  • East-West Medical Research Institute

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Healthcare Research Network - Chicago

    Flossmoor, Illinois 60422
    United States

    Site Not Available

  • Clinical Investigation Specialists

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • American Health Network of IN, LLC

    Franklin, Indiana 46131
    United States

    Site Not Available

  • Midwest Institute For Clinical Research

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • American Health Network of Indiana, LLC - New Albany

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Cotton O'Neil Clinic

    Topeka, Kansas 66606
    United States

    Site Not Available

  • L-MARC Research Center

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Centennial Medical Group

    Elkridge, Maryland 21075
    United States

    Site Not Available

  • MedStar Health Research Institute (MedStar Physician Based Research Network)

    Hyattsville, Maryland 20782
    United States

    Site Not Available

  • ActivMed Practices and Research

    Methuen, Massachusetts 01844
    United States

    Site Not Available

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan 48098
    United States

    Site Not Available

  • StudyMetrix Research

    Saint Peters, Missouri 63303
    United States

    Site Not Available

  • Glacier View Research Institute - Endocrinology

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Weill Cornell Medical College

    New York, New York 10065
    United States

    Site Not Available

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • PharmQuest

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Wake Forest University Baptist Medical Center (WFUBMC)

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Lillestol Research

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Aventiv Research Inc

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Intend Research, LLC

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Summit Research Network

    Portland, Oregon 97210
    United States

    Site Not Available

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania 17011
    United States

    Site Not Available

  • Tribe Clinical Research, LLC

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Dallas Diabetes Research Center

    Dallas, Texas 75230
    United States

    Site Not Available

  • North Texas Endocrine Center

    Dallas, Texas 75231
    United States

    Site Not Available

  • Biopharma Informatic, LLC

    Houston, Texas 77043
    United States

    Site Not Available

  • North Hills Family Medicine/North Hills Medical Research

    North Richland Hills, Texas 76180
    United States

    Site Not Available

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Northwest Houston Heart Center

    Tomball, Texas 77375
    United States

    Site Not Available

  • Health Research of Hampton Roads, Inc.

    Newport News, Virginia 23606
    United States

    Site Not Available

  • Capital Clinical Research Center

    Olympia, Washington 98502
    United States

    Site Not Available

  • Rainier Clinical Research Center

    Renton, Washington 98057
    United States

    Site Not Available

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