A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Tirzepatide Once Weekly Compared to Placebo in Adult Participants With Type 1 Diabetes and Obesity or Overweight
Status: Recruiting
Location: See all (147) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Have type 1 diabetes and on insulin treatment for at least one year prior to screening
• 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 start an intensive diet or exercise program during the study
Locations
United States
California
Sansum Diabetes Research Institute
RECRUITING
Goleta
Care Access - Santa Clarita
RECRUITING
Santa Clarita
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
Georgia
Atlanta Diabetes Associates
RECRUITING
Atlanta
Orita Clinical Research
RECRUITING
Decatur
North Georgia Clinical Research
RECRUITING
Woodstock
Hawaii
East-West Medical Research Institute
RECRUITING
Honolulu
Iowa
Iowa Diabetes and Endocrinology Research Center
RECRUITING
West Des Moines
Idaho
Rocky Mountain Clinical Research
RECRUITING
Idaho Falls
Illinois
Southern Illinois University School of Medicine
RECRUITING
Springfield
Indiana
Indiana University Health University Hospital
RECRUITING
Indianapolis
Kentucky
Saint Elizabeth Healthcare - Saint Elizabeth Covington Hospital
RECRUITING
Covington
Maryland
Endocrine and Metabolic Consultants
RECRUITING
Rockville
Minnesota
HealthPartners Institute dba International Diabetes Center
RECRUITING
Minneapolis
Mississippi
SKY Integrative Medical Center/SKYCRNG
RECRUITING
Ridgeland
Montana
Boeson Research MSO
RECRUITING
Missoula
North Carolina
Lucas Research, Inc.
RECRUITING
Morehead City
Nevada
Palm Research Center Sunset
RECRUITING
Las Vegas
Palm Research Center Tenaya
RECRUITING
Las Vegas
New York
Albany Medical College, Division of Community Endocrinology
RECRUITING
Albany
Research Foundation of SUNY - University of Buffalo
RECRUITING
Buffalo
NYC Research
RECRUITING
New York
SUNY Upstate Medical University
RECRUITING
Syracuse
Ohio
Care Access - Lima
RECRUITING
Lima
Oklahoma
Alliance for Multispecialty Research, LLC
RECRUITING
Norman
Pennsylvania
Suburban Research Associates
RECRUITING
West Chester
Texas
Texas Diabetes & Endocrinology, P.A.
RECRUITING
Austin
Velocity Clinical Research, Dallas
RECRUITING
Dallas
Tekton Research, LLC.
RECRUITING
Mckinney
Medrasa Clinical Research
RECRUITING
Wylie
Washington
Eastside Research Associates
RECRUITING
Redmond
Rainier Clinical Research Center
RECRUITING
Renton
Other Locations
Argentina
Centro de Investigaciones Metabólicas (CINME)
RECRUITING
Buenos Aires
CENUDIAB
RECRUITING
Buenos Aires
CIPREC
RECRUITING
Buenos Aires
Consultorio de Investigación Clínica EMO SRL
RECRUITING
Buenos Aires
Investigaciones Medicas Imoba Srl
RECRUITING
Buenos Aires
Centro Medico Privado San Vicente Diabetes
RECRUITING
Córdoba
Instituto de Investigaciones Clínicas Córdoba
RECRUITING
Córdoba
Centro de Investigaciones Médicas Mar del Plata
RECRUITING
Mar Del Plata
Instituto Médico Río Cuarto
RECRUITING
Río Cuarto
Fundacion Estudios Clinicos
RECRUITING
Rosario
Centro de Diagnóstico y Rehabilitación (CEDIR)
RECRUITING
Santa Fe
Centro de Salud e Investigaciones Médicas
RECRUITING
Santa Rosa
Brazil
Centro de Diabetes Curitiba
RECRUITING
Curitiba
Centro De Diabetes Metabolismo E Endocrinologia
RECRUITING
Fortaleza
Private Practice - Dr.Miguel N. Hissa
RECRUITING
Fortaleza
Universidade Federal de Goias
RECRUITING
Goiânia
CEPIC - Centro Paulista de Investigação Clínica
RECRUITING
São Paulo
CPCLIN
RECRUITING
São Paulo
CPQuali Pesquisa Clínica
RECRUITING
São Paulo
Hospital das Clinicas FMUSP
RECRUITING
São Paulo
IBTED - Tecnologia e Educação em Diabetes
NOT_YET_RECRUITING
São Paulo
CEDOES
RECRUITING
Vitória
Denmark
Esbjerg sygehus, Syddansk Universitetshospital
RECRUITING
Esbjerg
Steno Diabetes Center - Copenhagen
RECRUITING
Herlev
Regionshospitalet Gødstrup
RECRUITING
Herning
Nordsjællands Hospital - Hillerød
RECRUITING
Hillerød
Sjællands Universitetshospital Køge
RECRUITING
Køge
France
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
RECRUITING
Caen
Centre Hospitalier Sud Francilien
RECRUITING
Corbeil-essonnes
Hôtel-Dieu du Creusot - site Harfleur
RECRUITING
Le Creusot
Centre du diabète DIAB-eCARE
RECRUITING
Lyon
Hôpital de la Conception
RECRUITING
Marseille
Hôpital Européen Marseille
RECRUITING
Marseille
CHU Montpellier Lapeyronie Hospital
RECRUITING
Montpellier
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes
RECRUITING
Nantes
Hôpital NOVO
RECRUITING
Pontoise
CHU Strasbourg-Hautepierre
RECRUITING
Strasbourg
Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
RECRUITING
Toulon
CHU Rangueil
RECRUITING
Toulouse
Groupe Hospitalier Mutualiste Les Portes du Sud
RECRUITING
Vénissieux
Germany
Diabetespraxis Mergentheim
RECRUITING
Bad Mergentheim
Diabetes- und Stoffwechselpraxis Bochum
RECRUITING
Bochum
InnoDiab Forschung Gmbh
RECRUITING
Essen
Diabetes Zentrum Wilhelmsburg
RECRUITING
Hamburg
Klinikum Karlsburg
RECRUITING
Karlsburg
Universitätsklinikum Leipzig
RECRUITING
Leipzig
Institut für Diabetesforschung GmbH Münster
RECRUITING
Münster
RED-Institut GmbH
RECRUITING
Oldenburg
Arztpraxis Christine Kosch Pirna
RECRUITING
Pirna
Israel
Yitzhak Shamir Medical Center
RECRUITING
Beer Yaacov
Soroka Medical Center
RECRUITING
Beersheba
Rambam Health Care Campus
RECRUITING
Haifa
Institute of Diabetes, Technology and Research - Clalit Health
RECRUITING
Herzliya
Hadassah Medical Center
RECRUITING
Jerusalem
Rabin Medical Center
RECRUITING
Petah Tikva
Schneider Children's Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Diabetes Medical Center
RECRUITING
Tel Aviv
Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
IRCCS - AOU di Bologna
RECRUITING
Bologna
AOU Renato Dulbecco
RECRUITING
Catanzaro
Azienda Ospedaliera Universitaria Careggi
RECRUITING
Florence
Ospedale San Raffaele
RECRUITING
Milan
University of Naples Federico II
RECRUITING
Napoli
Azienda Ospedale - Università Padova
RECRUITING
Padua
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
RECRUITING
Roma
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
NOT_YET_RECRUITING
Torino
Japan
The Institute of Medical Science, Asahi Life Foundation
RECRUITING
Chūōku
Matoba Internal Medicine Clinic
RECRUITING
Ebina
Clinic Masae Minami
RECRUITING
Fukuoka
Japanese Red Cross Fukuoka Hospital
RECRUITING
Fukuoka
Hachioji Diabetes Clinic
RECRUITING
Hachioji-shi
Takai Internal Medicine Clinic
RECRUITING
Kamakura-shi
Shiraiwa Medical Clinic
RECRUITING
Kashiwara
Kasugai Municipal Hospital
RECRUITING
Kasugai
Kimitsu Chuo Hospital
RECRUITING
Kisarazu
Yamanashi Prefectural Central Hospital
RECRUITING
Kofu
Jinnouchi Hospital
RECRUITING
Kumamoto
Kumamoto Central Hospital - Kumamoto
RECRUITING
Kumamoto
Kure Medical Center
RECRUITING
Kure
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
RECRUITING
Matsuyama
Kozawa Eye Hospital and Diabetes Center
RECRUITING
Mito
Heiwadai Hospital
RECRUITING
Miyazaki
Soleil Chikusa Clinic
RECRUITING
Nagoya
Tosaki Clinic for Diabetes and Endocrinology
RECRUITING
Nagoya
Nakakinen clinic
RECRUITING
Naka
Abe Clinic
RECRUITING
Ōita
Osaka City General Hospital
RECRUITING
Osaka
Manda Memorial Hospital
RECRUITING
Sapporo
Odori Diabetes
RECRUITING
Sapporo
Shimonoseki Medical Center
RECRUITING
Shimonoseki
Tomonaga Clinic
RECRUITING
Shinjuku
Suruga Clinic
RECRUITING
Shizuoka
Tama Center Clinic Mirai
RECRUITING
Tama
Noritake Clinic
RECRUITING
Ushiku
Japanese Red Cross Society - Wakayama Medical Center
RECRUITING
Wakayama
Mexico
Enclifar Ensayos Clínicos Farmacológicos Sc
RECRUITING
Chihuahua City
Centro de Investigacion Medica de Occidente, S.C.
RECRUITING
Guadalajara
Unidad de Investigación Clínica y Atención Médica HEPA S.C.
RECRUITING
Guadalajara
Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente
RECRUITING
Guadalajara
Invecordis S.C.
RECRUITING
Hacienda De Las Palmas
CEINV Salud
RECRUITING
Monterrey
Clínica García Flores SC
RECRUITING
Monterrey
Consultorio Médico de Endocrinología y Pediatría
RECRUITING
Puebla City
Medsal Centro Médico
NOT_YET_RECRUITING
Tampico
Puerto Rico
Advanced Clinical Research, LLC
RECRUITING
Bayamón
Manati Center for Clinical Research
RECRUITING
Manatí
Spain
CHUAC-Complejo Hospitalario Universitario A Coruña
RECRUITING
A Coruña
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
RECRUITING
Ferrol
Hospital Universitario de Móstoles
RECRUITING
Móstoles
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2025-04-25
Estimated Completion Date: 2027-05
Participants
Target number of participants: 905
Treatments
Experimental: Tirzepatide Dose 1
Participants will receive tirzepatide subcutaneously (SC)
Experimental: Tirzepatide Dose 2
Participants will receive tirzepatide SC
Experimental: Tirzepatide Dose 3
Participants will receive tirzepatide SC
Experimental: Tirzepatide Dose 4
Participants will receive tirzepatide SC
Placebo_comparator: Placebo
Participants will receive placebo SC
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company