A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Long-Term Safety of Tirzepatide Once Weekly Compared to Placebo in Adults With Type 1 Diabetes and Obesity or Overweight
Status: Recruiting
Location: See all (74) 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 long-term in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 20 months.
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
Kaiser Permanente Bonita Medical Offices
RECRUITING
Bonita
AMCR Institute
RECRUITING
Escondido
Mary & Dick Allen Diabetes Center
RECRUITING
Newport Beach
University Clinical Investigators, Inc.
RECRUITING
Tustin
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
Florida
Metabolic Research Institute, Inc.
RECRUITING
West Palm Beach
Iowa
Iowa Diabetes and Endocrinology Research Center
RECRUITING
West Des Moines
Minnesota
HealthPartners Institute dba International Diabetes Center
RECRUITING
Minneapolis
Missouri
Clinical Research Professionals
RECRUITING
Chesterfield
Clinvest Headlands Llc
RECRUITING
Springfield
North Carolina
University of North Carolina Medical Center
RECRUITING
Chapel Hill
Nevada
Las Vegas Endocrinology
RECRUITING
Henderson
Texas
Velocity Clinical Research, Dallas
RECRUITING
Dallas
Juno Research
RECRUITING
Houston
Southern Endocrinology Associates
RECRUITING
Mesquite
Texas Diabetes & Endocrinology, P.A.
RECRUITING
Round Rock
San Antonio Clinical Trials
RECRUITING
San Antonio
Texas Valley Clinical Research
RECRUITING
Weslaco
Other Locations
Argentina
Buenos Aires Macula S.A
RECRUITING
Buenos Aires
Mautalen Salud e Investigación
RECRUITING
Buenos Aires
Stat Research S.A.
RECRUITING
Buenos Aires
Centro Diabetológico Dr. Waitman
RECRUITING
Córdoba
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
RECRUITING
Godoy Cruz
Centro de Investigaciones Clínicas Baigorria
RECRUITING
Granadero Baigorria
Instituto Médico Catamarca IMEC
RECRUITING
Rosario
Investigaciones Clínicas Tucumán
RECRUITING
San Miguel De Tucumán
Brazil
Centro de Pesquisa Clinica do Brasil
RECRUITING
Brasília
Centro de Pesquisa Sao Lucas
RECRUITING
Campinas
Quanta Diagnóstico e Terapia
RECRUITING
Curitiba
Instituto de Estudos e Pesquisas Clinicas do Ceara IEP-CE
NOT_YET_RECRUITING
Fortaleza
Cendi - Endocrinologia e Diabetes
RECRUITING
Goiânia
Instituto da Crianca com Diabetes
NOT_YET_RECRUITING
Porto Alegre
IBPClin - Instituto Brasil de Pesquisa Clínica
RECRUITING
Rio De Janeiro
CEPIC - Centro Paulista de Investigação Clínica
RECRUITING
São Paulo
CPCLIN
RECRUITING
São Paulo
Canada
Endocrinologie Oasis
RECRUITING
Montreal
Centricity Research Ottawa LMC Endocrinology
RECRUITING
Ottawa
Centre de Recherche Saint-Louis
RECRUITING
Sherbrooke
TLC Diabetes and Endocrinology
RECRUITING
Surrey
Care Access - Cape Breton
RECRUITING
Sydney
France
Centre Hospitalier Universitaire - Hôpitaux de Rouen - Hôpital de Bois-Guillaume
RECRUITING
Bois-guillaume
Centre Hospitalier Sud Francilien
RECRUITING
Corbeil-essonnes
Centre Hospitalier Universitaire de Grenoble
RECRUITING
Grenoble
Hôtel-Dieu du Creusot - site Harfleur
RECRUITING
Le Creusot
Hôpital de la Conception
RECRUITING
Marseille
Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière
NOT_YET_RECRUITING
Paris
CHU Rangueil
RECRUITING
Toulouse
Groupe Hospitalier Mutualiste Les Portes du Sud
RECRUITING
Vénissieux
Greece
Athens Medical Center
RECRUITING
Athens
Iatriko Paleou Falirou Medical Center
RECRUITING
Palaió Fáliro
Euromedica General Clinic of Thessaloniki
NOT_YET_RECRUITING
Thessaloniki
Ippokrateio General Hospital of Thessaloniki
RECRUITING
Thessaloniki
Mexico
Enclifar Ensayos Clínicos Farmacológicos Sc
RECRUITING
Chihuahua City
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
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
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
NOT_YET_RECRUITING
Mexico City
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
Romania
CMI DNBM Dr. Pop Lavinia
RECRUITING
Baia Mare
Mariodiab Clinic
RECRUITING
Brasov
Centrul medical DiabNutriMed
RECRUITING
Bucharest
Diabet Med
RECRUITING
Bucharest
Sanamed Hospital
NOT_YET_RECRUITING
Bucharest
Diamed Obesity
RECRUITING
Galați
Centrul Medical Consultmed
RECRUITING
Iași
Rinart Diab SRL
RECRUITING
Târgovişte
Spain
Hospital Infanta Cristina
RECRUITING
Badajoz
Hospital Germans Trias i Pujol
RECRUITING
Badalona
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
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: 2025-05-12
Estimated Completion Date: 2027-12
Participants
Target number of participants: 465
Treatments
Experimental: Tirzepatide
Participants will receive tirzepatide subcutaneously (SC)
Placebo_comparator: Placebo
Participants will receive placebo SC
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company