A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight

Last updated: May 23, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes Prevention

Diabetes And Hypertension

Diabetes Mellitus Types I And Ii

Treatment

Tirzepatide

Placebo

Clinical Study ID

NCT06914895
27285
2024-519684-17-00
I8F-MC-GPJA
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to find out how well and how safely tirzepatide works in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 49 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have type 1 diabetes and on insulin treatment for at least one year prior toscreening

  • Have an HbA1c value of 7.0% to 10.5% inclusive, at screening

  • Have a body mass index (BMI) of ≥25 kilograms per square meter (kg/m2) at screening

  • Are of stable weight for at least 90 days prior to screening and agree to not startan intensive diet or exercise program during the study

Exclusion

Exclusion Criteria:

  • Have experienced two or more events requiring hospitalization due to poor glucosecontrol (hyperglycemia or (diabetic ketoacidosis (DKA)) during the period of 180days prior to screening and until randomization.

  • Have experienced one or more events of severe hypoglycemia during the period of 90days prior to screening and until randomization.

  • Are currently receiving or planning to receive treatment for diabetic retinopathyand/or macular edema

  • Have had chronic or acute pancreatitis

  • Have used any weight loss drugs or alternative remedies, including herbal ornutritional supplements, within 90 days prior to screening

Study Design

Total Participants: 905
Treatment Group(s): 2
Primary Treatment: Tirzepatide
Phase: 3
Study Start date:
April 25, 2025
Estimated Completion Date:
May 31, 2027

Connect with a study center

  • Centro de Investigaciones Médicas Mar del Plata

    Mar del Plata, Buenos Aires 7600
    Argentina

    Site Not Available

  • CIPREC

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1119ACN
    Argentina

    Site Not Available

  • Investigaciones Medicas Imoba Srl

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1056ABH
    Argentina

    Site Not Available

  • Consultorio de Investigación Clínica EMO SRL

    Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires C1405BUB
    Argentina

    Site Not Available

  • Centro Medico Privado San Vicente Diabetes

    Cordoba, Córdoba 5006
    Argentina

    Site Not Available

  • Instituto Médico Río Cuarto

    Río Cuarto, Córdoba X5800AEV
    Argentina

    Site Not Available

  • Centro de Salud e Investigaciones Médicas

    Santa Rosa, La Pampa L6300
    Argentina

    Site Not Available

  • Fundacion Estudios Clinicos

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • CENUDIAB

    Ciudad Autónoma de Buenos Aires, C1440AAD
    Argentina

    Site Not Available

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aires, C1056ABI
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clínicas Córdoba

    Córdoba, 5000
    Argentina

    Site Not Available

  • Centro de Diagnóstico y Rehabilitación (CEDIR)

    Santa Fe, 3000
    Argentina

    Site Not Available

  • Centro De Diabetes Metabolismo E Endocrinologia

    Fortaleza, Ceará 60175-047
    Brazil

    Site Not Available

  • Private Practice - Dr.Miguel N. Hissa

    Fortaleza, Ceará 60430-350
    Brazil

    Site Not Available

  • CEDOES

    Vitória, Espírito Santo 29055450
    Brazil

    Site Not Available

  • Universidade Federal de Goias

    Goiania, Goiás 74605-020
    Brazil

    Site Not Available

  • Centro de Diabetes Curitiba

    Curitiba, Paraná 80810-040
    Brazil

    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

  • CPQuali Pesquisa Clínica

    São Paulo, 01228-000
    Brazil

    Site Not Available

  • Hospital das Clinicas FMUSP

    São Paulo, 05403-000
    Brazil

    Site Not Available

  • IBTED - Tecnologia e Educação em Diabetes

    São Paulo, 04038-032
    Brazil

    Site Not Available

  • Steno Diabetes Center - Copenhagen

    Herlev, Hovedstaden 2730
    Denmark

    Site Not Available

  • Nordsjællands Hospital - Hillerød

    Hillerod, Hovedstaden 3400
    Denmark

    Site Not Available

  • Regionshospitalet Gødstrup

    Herning, Midtjylland 7400
    Denmark

    Site Not Available

  • Sjællands Universitetshospital Køge

    Køge, Sjælland 4600
    Denmark

    Site Not Available

  • Sydvestjyst Sygehus

    Esbjerg, Syddanmark 6700
    Denmark

    Site Not Available

  • CHU Strasbourg-Hautepierre

    Strasbourg, Alsace 67098
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre

    Caen, Basse-Normandie 14033
    France

    Site Not Available

  • Hôpital Européen Marseille

    Marseille, Bouches-du-Rhône 13003
    France

    Site Not Available

  • Hôpital de la Conception

    Marseille, Bouches-du-Rhône 13005
    France

    Site Not Available

  • Hôtel-Dieu du Creusot - site Harfleur

    Le Creusot, Bourgogne 71200
    France

    Site Not Available

  • CHU Rangueil

    Toulouse cedex 9, Haute-Garonne 31059
    France

    Site Not Available

  • CHU Montpellier Lapeyronie Hospital

    Montpellier, Hérault 34295
    France

    Site Not Available

  • Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes

    Nantes Cedex 1, Loire-Atlantique 44093
    France

    Site Not Available

  • Centre Hospitalier intercommunal de Toulon La Seyne sur Mer

    Toulon, Provence-Alpes-Côte-d'Azur 83100
    France

    Site Not Available

  • Centre du diabète DIAB-eCARE

    Lyon, Rhône-Alpes 69008
    France

    Site Not Available

  • Groupe Hospitalier Mutualiste Les Portes du Sud

    Vénissieux, Rhône-Alpes 69200
    France

    Site Not Available

  • Hôpital NOVO

    Pontoise, Val-d'Oise 95300
    France

    Site Not Available

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, Île-de-France 91106
    France

    Site Not Available

  • Diabetespraxis Mergentheim

    Bad Mergentheim, Baden-Württemberg 97980
    Germany

    Site Not Available

  • Klinikum Karlsburg

    Karlsburg, Mecklenburg-Vorpommern 17495
    Germany

    Site Not Available

  • Diabetes- und Stoffwechselpraxis Bochum

    Bochum, Nordrhein-Westfalen 44869
    Germany

    Site Not Available

  • InnoDiab Forschung Gmbh

    Essen, Nordrhein-Westfalen 45136
    Germany

    Site Not Available

  • Institut für Diabetesforschung GmbH Münster

    Münster, Nordrhein-Westfalen 48145
    Germany

    Site Not Available

  • Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz

    Ludwigshafen am Rhein, Rheinland-Pfalz 67059
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig

    Leipzig, Sachsen 04103
    Germany

    Site Not Available

  • Arztpraxis Christine Kosch Pirna

    Pirna, Sachsen 01796
    Germany

    Site Not Available

  • RED-Institut GmbH

    Oldenburg, Schleswig-Holstein 23758
    Germany

    Site Not Available

  • Diabetes Zentrum Wilhelmsburg

    Hamburg, 21109
    Germany

    Site Not Available

  • Soroka Medical Center

    Be'er Sheva, HaDarom 8410101
    Israel

    Site Not Available

  • Yitzhak Shamir Medical Center

    Beer Yaacov, HaMerkaz 70300
    Israel

    Site Not Available

  • Institute of Diabetes, Technology and Research - Clalit Health

    Herzliya, HaMerkaz 4600201
    Israel

    Site Not Available

  • Rabin Medical Center

    Petah-Tikva, HaMerkaz 4941492
    Israel

    Site Not Available

  • Schneider Children's Medical Center

    Petah-Tikva, HaMerkaz 4920235
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, HaMerkaz 5262100
    Israel

    Site Not Available

  • Diabetes Medical Center

    Tel Aviv, Tell Abīb 51549
    Israel

    Site Not Available

  • Sourasky Medical Center

    Tel Aviv, Tell Abīb 6423906
    Israel

    Site Not Available

  • Hadassah Medical Center

    Jerusalem, Yerushalayim 9112001
    Israel

    Site Not Available

  • Rambam Health Care Campus

    Haifa, Ḥeifā 3109601
    Israel

    Site Not Available

  • University of Naples Federico II

    Napoli, Campania 80100
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

    Torino, Piemonte 10126
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi

    Firenze, Toscana 50134
    Italy

    Site Not Available

  • Azienda Ospedale - Università Padova

    Padova, Veneto 35128
    Italy

    Site Not Available

  • IRCCS - AOU di Bologna

    Bologna, 40138
    Italy

    Site Not Available

  • AOU Renato Dulbecco

    Catanzaro, 88100
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milano, 20132
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

    Roma, 00168
    Italy

    Site Not Available

  • Kasugai Municipal Hospital

    Kasugai, Aichi 486-8510
    Japan

    Site Not Available

  • Soleil Chikusa Clinic

    Nagoya, Aichi 464-0858
    Japan

    Site Not Available

  • Tosaki Clinic for Diabetes and Endocrinology

    Nagoya-shi, Aichi 468-0009
    Japan

    Site Not Available

  • Kimitsu Chuo Hospital

    Kisarazu, Chiba 292-8535
    Japan

    Site Not Available

  • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism

    Matsuyama, Ehime 790-0034
    Japan

    Site Not Available

  • Kure Medical Center

    Kure, Hiroshima 737-0023
    Japan

    Site Not Available

  • Manda Memorial Hospital

    Sapporo, Hokkaido 060-0062
    Japan

    Site Not Available

  • Odori Diabetes

    Sapporo, Hokkaido 060-0001
    Japan

    Site Not Available

  • Kozawa Eye Hospital and Diabetes Center

    Mito, Ibaraki 310-0845
    Japan

    Site Not Available

  • Nakakinen clinic

    Naka, Ibaraki 311-0113
    Japan

    Site Not Available

  • Noritake Clinic

    Ushiku, Ibaraki 300-1207
    Japan

    Site Not Available

  • Matoba Internal Medicine Clinic

    Ebina, Kanagawa 243-0432
    Japan

    Site Not Available

  • Takai Internal Medicine Clinic

    Kamakura-shi, Kanagawa 247-0056
    Japan

    Site Not Available

  • Shiraiwa Medical Clinic

    Kashiwara, Osaka 582-0005
    Japan

    Site Not Available

  • Suruga Clinic

    Shizuoka-city, Shizuoka 424-0855
    Japan

    Site Not Available

  • The Institute of Medical Science, Asahi Life Foundation

    Chuo-ku, Tokyo 103-0002
    Japan

    Site Not Available

  • Hachioji Diabetes Clinic

    Hachioji-shi, Tokyo 192-0083
    Japan

    Site Not Available

  • Tomonaga Clinic

    Shinjuku, Tokyo 160-0022
    Japan

    Site Not Available

  • Tama Center Clinic Mirai

    Tama, Tokyo 206-0033
    Japan

    Site Not Available

  • Shimonoseki Medical Center

    Shimonoseki, Yamaguchi 750-0061
    Japan

    Site Not Available

  • Yamanashi Prefectural Central Hospital

    Kofu, Yamanashi 400-8506
    Japan

    Site Not Available

  • Clinic Masae Minami

    Fukuoka, 815-0071
    Japan

    Site Not Available

  • Japanese Red Cross Fukuoka Hospital

    Fukuoka, 815-8555
    Japan

    Site Not Available

  • Jinnouchi Hospital

    Kumamoto, 862-0976
    Japan

    Site Not Available

  • Kumamoto Central Hospital - Kumamoto

    Kumamoto, 862-0965
    Japan

    Site Not Available

  • Heiwadai Hospital

    Miyazaki, 880-0034
    Japan

    Site Not Available

  • Abe Clinic

    Oita, 870-0039
    Japan

    Site Not Available

  • Osaka City General Hospital

    Osaka, 534-0021
    Japan

    Site Not Available

  • Japanese Red Cross Society - Wakayama Medical Center

    Wakayama, 640-8558
    Japan

    Site Not Available

  • Centro de Investigacion Medica de Occidente, S.C.

    Guadalajara, Jalisco 44260
    Mexico

    Site Not Available

  • Unidad de Investigación Clínica y Atención Médica HEPA S.C.

    Guadalajara, Jalisco 44670
    Mexico

    Site Not Available

  • Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente

    Guadalajara, Jalisco 44150
    Mexico

    Site Not Available

  • Invecordis S.C.

    Hacienda De Las Palmas, México 52763
    Mexico

    Site Not Available

  • CEINV Salud

    Monterrey, Nuevo León 64020
    Mexico

    Site Not Available

  • Clínica García Flores SC

    Monterrey, Nuevo León 64610
    Mexico

    Site Not Available

  • Medsal Centro Médico

    Tampico, Tamaulipas 89210
    Mexico

    Site Not Available

  • Enclifar Ensayos Clínicos Farmacológicos Sc

    Chihuahua, 31110
    Mexico

    Site Not Available

  • Consultorio Médico de Endocrinología y Pediatría

    Puebla, 72190
    Mexico

    Site Not Available

  • Advanced Clinical Research, LLC

    Bayamón, 00959
    Puerto Rico

    Site Not Available

  • Manati Center for Clinical Research

    Manati, 00674
    Puerto Rico

    Site Not Available

  • CHUAC-Complejo Hospitalario Universitario A Coruña

    A Coruña, A Coruña [La Coruña] 15006
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval

    Ferrol, A Coruña [La Coruña] 15405
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [Cataluña] 08036
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalunya [Cataluña] 08041
    Spain

    Site Not Available

  • Hospital Universitario de Móstoles

    Móstoles, Madrid 28935
    Spain

    Site Not Available

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Sansum Diabetes Research Institute

    Goleta, California 93111
    United States

    Site Not Available

  • Care Access - Santa Clarita

    Santa Clarita, California 91321
    United States

    Active - Recruiting

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Atlanta Diabetes Associates

    Atlanta, Georgia 30318
    United States

    Active - Recruiting

  • Orita Clinical Research

    Decatur, Georgia 30034
    United States

    Active - Recruiting

  • North Georgia Clinical Research

    Woodstock, Georgia 30189
    United States

    Active - Recruiting

  • East-West Medical Research Institute

    Honolulu, Hawaii 96814
    United States

    Active - Recruiting

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho 83404
    United States

    Active - Recruiting

  • Southern Illinois University School of Medicine

    Springfield, Illinois 62702
    United States

    Site Not Available

  • Indiana University Health University Hospital

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa 50266
    United States

    Active - Recruiting

  • Saint Elizabeth Healthcare - Saint Elizabeth Covington Hospital

    Covington, Kentucky 41011
    United States

    Site Not Available

  • Endocrine and Metabolic Consultants

    Rockville, Maryland 20852
    United States

    Active - Recruiting

  • HealthPartners Institute dba International Diabetes Center

    Minneapolis, Minnesota 55416
    United States

    Active - Recruiting

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland, Mississippi 39157
    United States

    Active - Recruiting

  • Boeson Research MSO

    Missoula, Montana 59804
    United States

    Active - Recruiting

  • Palm Research Center Sunset

    Las Vegas, Nevada 89148
    United States

    Active - Recruiting

  • Palm Research Center Tenaya

    Las Vegas, Nevada 89128
    United States

    Active - Recruiting

  • Albany Medical College, Division of Community Endocrinology

    Albany, New York 12203
    United States

    Site Not Available

  • Research Foundation of SUNY - University of Buffalo

    Buffalo, New York 14221
    United States

    Active - Recruiting

  • NYC Research

    New York, New York 10016
    United States

    Active - Recruiting

  • SUNY Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

  • Lucas Research, Inc.

    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

  • Care Access - Lima

    Lima, Ohio 45805
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research, LLC

    Norman, Oklahoma 73069
    United States

    Active - Recruiting

  • Suburban Research Associates

    West Chester, Pennsylvania 19380
    United States

    Active - Recruiting

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas 78731
    United States

    Active - Recruiting

  • Velocity Clinical Research, Dallas

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • Tekton Research, LLC.

    McKinney, Texas 75069
    United States

    Active - Recruiting

  • Medrasa Clinical Research

    Wylie, Texas 75098
    United States

    Active - Recruiting

  • Eastside Research Associates

    Redmond, Washington 98052
    United States

    Active - Recruiting

  • Rainier Clinical Research Center

    Renton, Washington 98057
    United States

    Active - Recruiting

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