NCT06962280Active, not recruitingPhase 3
A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight
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
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 465 (estimated)
- First submitted
- 6 May 2025
- Start date
- 12 May 2025
- Primary completion date
- Nov 2026
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Obesity, Type 1 diabetes
- NCT number
- NCT06962280
- EU CT number
- 2024-519685-51-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 465
- From 12 May 2025 to the primary completion date, Nov 2026
- 79 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have experienced one or more events of severe hypoglycemia during the period of 90 days prior to screening and until randomization.
- Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
- Have used any weight loss drugs or alternative remedies, including herbal or nutritional supplements, within 90 days prior to screening
Lab values
- Have experienced two or more events requiring hospitalization due to poor glucose control (hyperglycemia or (diabetic ketoacidosis (DKA)) during the period of 180 days prior to screening and until randomization.
Other
- Have had chronic or acute pancreatitis
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (79)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Buenos Aires Macula S.A Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Stat Research S.A. Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Mautalen Salud e Investigación Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Centro Diabetológico Dr. Waitman Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| CIPADI - Centro Integral de Prevencion y Atencion en Diabetes Coordinator of this site? Confirm its status | Godoy Cruz | Argentina | Unknown status |
| Centro de Investigaciones Clínicas Baigorria Coordinator of this site? Confirm its status | Granadero Baigorria | Argentina | Unknown status |
| Instituto Médico Catamarca IMEC Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Investigaciones Clínicas Tucumán Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| Centro de Pesquisa Clínica do Brasil Coordinator of this site? Confirm its status | Brasília | Brazil | Unknown status |
| Centro de Pesquisa Sao Lucas Coordinator of this site? Confirm its status | Campinas | Brazil | Unknown status |
| Quanta Diagnóstico e Terapia Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Cendi - Endocrinologia e Diabetes Coordinator of this site? Confirm its status | Goiânia | Brazil | Unknown status |
| Instituto da Crianca com Diabetes Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| IBPClin - Instituto Brasil de Pesquisa Clínica Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| CEPIC - Centro Paulista de Investigação Clínica Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| CPCLIN Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Endocrinologie Oasis Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Centricity Research Ottawa LMC Endocrinology Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Centre de Recherche Saint-Louis Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
| TLC Diabetes and Endocrinology Coordinator of this site? Confirm its status | Surrey | Canada | Unknown status |
| Care Access - Cape Breton Coordinator of this site? Confirm its status | Sydney | Canada | Unknown status |
| INTENDIA klinika s.r.o. Coordinator of this site? Confirm its status | Chrudim III | Czechia | Unknown status |
| AIDIN VK s.r.o. Coordinator of this site? Confirm its status | Hranice | Czechia | Unknown status |
| MUDr. Tomas Edelsberger Coordinator of this site? Confirm its status | Krnov | Czechia | Unknown status |
| Diabetologicke centrum s.r.o. Coordinator of this site? Confirm its status | Olomouc | Czechia | Unknown status |
| ResTrial s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Milan Kvapil s.r.o., Diabetologicka ambulance Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Hospital Infanta Cristina Coordinator of this site? Confirm its status | Badajoz | Spain | Unknown status |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Centre Hospitalier Universitaire - Hôpitaux de Rouen - Hôpital de Bois-Guillaume Coordinator of this site? Confirm its status | Bois-Guillaume | France | Unknown status |
| Centre Hospitalier Sud Francilien Coordinator of this site? Confirm its status | Corbeil-Essonnes | France | Unknown status |
| Centre Hospitalier Universitaire de Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Hôtel-Dieu du Creusot - site Harfleur Coordinator of this site? Confirm its status | Le Creusot | France | Unknown status |
| Hôpital de la Conception Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU Rangueil Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Groupe Hospitalier Mutualiste Les Portes du Sud Coordinator of this site? Confirm its status | Vénissieux | France | Unknown status |
| Athens Medical Center Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Iatriko Paleou Falirou Medical Center Coordinator of this site? Confirm its status | Palaió Fáliro | Greece | Unknown status |
| Ippokrateio General Hospital of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Euromedica General Clinic of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Enclifar Ensayos Clínicos Farmacológicos Sc Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Unknown status |
| Private Practice - Dr. Arechavaleta Granell Maria del Rosario Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Unidad de Investigación Clínica y Atención Médica HEPA S.C. Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| CEINV Salud Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Clínica García Flores SC Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Consultorio Médico de Endocrinología y Pediatría Coordinator of this site? Confirm its status | Puebla City | Mexico | Unknown status |
| Medsal Centro Médico Coordinator of this site? Confirm its status | Tampico | Mexico | Unknown status |
| CMI DNBM Dr. Pop Lavinia Coordinator of this site? Confirm its status | Baia Mare | Romania | Unknown status |
| Mariodiab Clinic Coordinator of this site? Confirm its status | Brasov | Romania | Unknown status |
| Diabet Med Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Sanamed Hospital Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Centrul medical DiabNutriMed Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Diamed Obesity Coordinator of this site? Confirm its status | Galați | Romania | Unknown status |
| Centrul Medical Consultmed Coordinator of this site? Confirm its status | Iași | Romania | Unknown status |
| Rinart Diab SRL Coordinator of this site? Confirm its status | Targoviste | Romania | Unknown status |
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Kaiser Permanente Bonita Medical Offices Coordinator of this site? Confirm its status | Bonita | United States | Unknown status |
| University of North Carolina Medical Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Clinical Research Professionals Coordinator of this site? Confirm its status | Chesterfield | United States | Unknown status |
| Velocity Clinical Research, Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| AMCR Institute Coordinator of this site? Confirm its status | Escondido | United States | Unknown status |
| Las Vegas Endocrinology Coordinator of this site? Confirm its status | Henderson | United States | Unknown status |
| Juno Research Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Southern Endocrinology Associates Coordinator of this site? Confirm its status | Mesquite | United States | Unknown status |
| HealthPartners Institute dba International Diabetes Center Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Mary & Dick Allen Diabetes Center Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| Texas Diabetes & Endocrinology, P.A. Coordinator of this site? Confirm its status | Round Rock | United States | Unknown status |
| San Antonio Clinical Trials Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Clinvest Headlands LLC Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| University Clinical Investigators, Inc. Coordinator of this site? Confirm its status | Tustin | United States | Unknown status |
| Texas Valley Clinical Research Coordinator of this site? Confirm its status | Weslaco | United States | Unknown status |
| Iowa Diabetes and Endocrinology Research Center Coordinator of this site? Confirm its status | West Des Moines | United States | Unknown status |
| Metabolic Research Institute, Inc Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.