A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities

Last updated: December 6, 2024
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

Tirzepatide

Semaglutide 2.4 mg

Semaglutide

Clinical Study ID

NCT05822830
17203
U1111-1283-5404
I8F-MC-GPHJ
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this phase 3b study is to evaluate the efficacy and safety of tirzepatide compared with semaglutide in adult participants who have obesity or overweight with weight related comorbidities without Type 2 Diabetes. The study will last around 74 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a body mass index (BMI) of ≥30 kilogram per square meter (kg/m²) or ≥27 kg/m²and previously diagnosed with at least one of the following weight relatedcomorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovasculardisease

  • Have a history of at least 1 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

Study Design

Total Participants: 751
Treatment Group(s): 3
Primary Treatment: Tirzepatide
Phase: 3
Study Start date:
April 21, 2023
Estimated Completion Date:
November 13, 2024

Connect with a study center

  • Consultorio de Investigación Clínica EMO SRL

    Ciudad Autonoma de Buenos Aire, Buenos Air C1405BUB
    Argentina

    Site Not Available

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aire, Buenos Aires 1056
    Argentina

    Site Not Available

  • Centro Médico Viamonte

    Buenos Aires, Ciudad Aut C1120AAC
    Argentina

    Site Not Available

  • Antwerp University Hospital

    Edegem, Antwerpen 2650
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, Vlaams-Brabant 3000
    Belgium

    Site Not Available

  • Az Damiaan vzw

    Oostende, West-Vlaanderen 8400
    Belgium

    Site Not Available

  • AZ Delta vzw

    Roeselare, West-Vlaanderen 8800
    Belgium

    Site Not Available

  • CPCLIN

    Sao Paulo, São Paulo 01228-200
    Brazil

    Site Not Available

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, 04266-010
    Brazil

    Site Not Available

  • LMC Clinical Research Inc. (Brampton)

    Brampton, Ontario L6S 0C6
    Canada

    Site Not Available

  • Wharton Medical Clinic

    Hamilton, Ontario L8L 5G8
    Canada

    Site Not Available

  • Bluewater Clinical Research Group Inc.

    Sarnia, Ontario N7T 4X3
    Canada

    Site Not Available

  • Dr. Anil K. Gupta Medicine Professional Corporation

    Toronto, Ontario M9V 4B4
    Canada

    Site Not Available

  • Manna Research

    Lévis, Quebec G6W 0M5
    Canada

    Site Not Available

  • Praxis Sauter & Sauter & Vorbach

    Wangen im Allgäu, Baden-Württemberg 88239
    Germany

    Site Not Available

  • ClinPhenomics CVC GmbH

    Frankfurt, Hessen 60596
    Germany

    Site Not Available

  • Medizentrum Essen Borbeck

    Essen, Nordrhein-Westfalen 45355
    Germany

    Site Not Available

  • Schwerpunktpraxis für Diabetes und Ernährungsmedizin Dr. med. Winfried Keuthage

    Münster, Nordrhein-Westfalen 48153
    Germany

    Site Not Available

  • AmBeNet GmbH

    Leipzig, Sachsen 04107
    Germany

    Site Not Available

  • Diabeteszentrum Hamburg West

    Hamburg, 22607
    Germany

    Site Not Available

  • NZOZ Medica

    Lublin, Lubelskie 20-538
    Poland

    Site Not Available

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

    Gdansk, Pomorskie 80-546
    Poland

    Site Not Available

  • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

    Lodz, Łódzkie
    Poland

    Site Not Available

  • Puerto Rico Medical Research

    Ponce, 00717
    Puerto Rico

    Site Not Available

  • Wellness clinical Research Vega Baja

    Vega Baja, 00694
    Puerto Rico

    Site Not Available

  • Staploe Medical Centre

    Ely, Cambridgeshire CB7 5JD
    United Kingdom

    Site Not Available

  • Knowle House Surgery

    Plymouth, Devon PL5 3JB
    United Kingdom

    Site Not Available

  • Hull Royal Infirmary

    Hull, Kingston Upon Hull HU3 2JZ
    United Kingdom

    Site Not Available

  • Wickersley Health Centre - Clifton Medical Centre

    Rotherham, S65 1DA
    United Kingdom

    Site Not Available

  • Cahaba Research

    Birmingham, Alabama 35242
    United States

    Site Not Available

  • Cahaba Research - Pelham

    Pelham, Alabama 35124
    United States

    Site Not Available

  • Southern California Dermatology, Inc.

    Santa Ana, California 92701
    United States

    Site Not Available

  • Encompass Clinical Research

    Spring Valley, California 91978
    United States

    Site Not Available

  • University Clinical Investigators, Inc.

    Tustin, California 92780
    United States

    Site Not Available

  • MD Clinical

    Hallandale Beach, Florida 33009
    United States

    Site Not Available

  • Velocity Clinical Research, Hallandale Beach

    Hallandale Beach, Florida 33009
    United States

    Site Not Available

  • New Horizon Research Center

    Miami, Florida 33165
    United States

    Site Not Available

  • ForCare Clinical Research

    Tampa, Florida 33613-1244
    United States

    Site Not Available

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia 30291
    United States

    Site Not Available

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa 50265
    United States

    Site Not Available

  • L-MARC Research Center

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan 48098
    United States

    Site Not Available

  • Prime Health and Wellness/SKYCRNG

    Fayette, Mississippi 39069
    United States

    Site Not Available

  • SKY Clinical Research Network Group - Hall

    Fayette, Mississippi 39069
    United States

    Site Not Available

  • StudyMetrix Research

    Saint Peters, Missouri 63303
    United States

    Site Not Available

  • Palm Research Center Sunset

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • Palm Research Center Tenaya

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Weill Cornell Medical College

    New York, New York 10021
    United States

    Site Not Available

  • PharmQuest

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • PharmQuest Life Sciences, LLC

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Lillestol Research

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Intend Research, LLC

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Tribe Clinical Research, LLC

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • WR-Clinsearch, LLC

    Chattanooga, Tennessee 37421
    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

  • Velocity Clinical Research, Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • Biopharma Informatic, LLC

    Houston, Texas 77043
    United States

    Site Not Available

  • Endocrine Ips, Pllc

    Houston, Texas 77079
    United States

    Site Not Available

  • PlanIt Research, PLLC

    Houston, Texas 77079
    United States

    Site Not Available

  • Southern Endocrinology Associates

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Pinnacle Clinical Research

    San Antonio, Texas 78229
    United States

    Site Not Available

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