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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
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

Full criteria on ClinicalTrials.gov

Sites (79)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Buenos Aires Macula S.A
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Buenos AiresArgentinaUnknown status
Stat Research S.A.
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Buenos AiresArgentinaUnknown status
Mautalen Salud e Investigación
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Buenos AiresArgentinaUnknown status
Centro Diabetológico Dr. Waitman
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CórdobaArgentinaUnknown status
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
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Godoy CruzArgentinaUnknown status
Centro de Investigaciones Clínicas Baigorria
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Granadero BaigorriaArgentinaUnknown status
Instituto Médico Catamarca IMEC
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RosarioArgentinaUnknown status
Investigaciones Clínicas Tucumán
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San Miguel de TucumánArgentinaUnknown status
Centro de Pesquisa Clínica do Brasil
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BrasíliaBrazilUnknown status
Centro de Pesquisa Sao Lucas
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CampinasBrazilUnknown status
Quanta Diagnóstico e Terapia
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CuritibaBrazilUnknown status
Cendi - Endocrinologia e Diabetes
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GoiâniaBrazilUnknown status
Instituto da Crianca com Diabetes
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Porto AlegreBrazilUnknown status
IBPClin - Instituto Brasil de Pesquisa Clínica
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Rio de JaneiroBrazilUnknown status
CEPIC - Centro Paulista de Investigação Clínica
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São PauloBrazilUnknown status
CPCLIN
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São PauloBrazilUnknown status
Endocrinologie Oasis
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MontrealCanadaUnknown status
Centricity Research Ottawa LMC Endocrinology
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OttawaCanadaUnknown status
Centre de Recherche Saint-Louis
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SherbrookeCanadaUnknown status
TLC Diabetes and Endocrinology
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SurreyCanadaUnknown status
Care Access - Cape Breton
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SydneyCanadaUnknown status
INTENDIA klinika s.r.o.
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Chrudim IIICzechiaUnknown status
AIDIN VK s.r.o.
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HraniceCzechiaUnknown status
MUDr. Tomas Edelsberger
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KrnovCzechiaUnknown status
Diabetologicke centrum s.r.o.
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OlomoucCzechiaUnknown status
ResTrial s.r.o.
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PragueCzechiaUnknown status
Milan Kvapil s.r.o., Diabetologicka ambulance
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PragueCzechiaUnknown status
Hospital Infanta Cristina
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BadajozSpainUnknown status
Hospital Germans Trias i Pujol
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BadalonaSpainUnknown status
Hospital Clinic de Barcelona
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BarcelonaSpainUnknown status
Hospital Universitario Ramón y Cajal
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MadridSpainUnknown status
Hospital Universitario Virgen del Rocio
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SevilleSpainUnknown status
Centre Hospitalier Universitaire - Hôpitaux de Rouen - Hôpital de Bois-Guillaume
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Bois-GuillaumeFranceUnknown status
Centre Hospitalier Sud Francilien
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Corbeil-EssonnesFranceUnknown status
Centre Hospitalier Universitaire de Grenoble
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GrenobleFranceUnknown status
Hôtel-Dieu du Creusot - site Harfleur
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Le CreusotFranceUnknown status
Hôpital de la Conception
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MarseilleFranceUnknown status
Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière
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ParisFranceUnknown status
CHU Rangueil
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ToulouseFranceUnknown status
Groupe Hospitalier Mutualiste Les Portes du Sud
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VénissieuxFranceUnknown status
Athens Medical Center
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AthensGreeceUnknown status
Iatriko Paleou Falirou Medical Center
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Palaió FáliroGreeceUnknown status
Ippokrateio General Hospital of Thessaloniki
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ThessalonikiGreeceUnknown status
Euromedica General Clinic of Thessaloniki
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ThessalonikiGreeceUnknown status
Enclifar Ensayos Clínicos Farmacológicos Sc
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Chihuahua CityMexicoUnknown status
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
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GuadalajaraMexicoUnknown status
Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente
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GuadalajaraMexicoUnknown status
Unidad de Investigación Clínica y Atención Médica HEPA S.C.
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GuadalajaraMexicoUnknown status
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
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Mexico CityMexicoUnknown status
CEINV Salud
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MonterreyMexicoUnknown status
Clínica García Flores SC
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MonterreyMexicoUnknown status
Consultorio Médico de Endocrinología y Pediatría
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Puebla CityMexicoUnknown status
Medsal Centro Médico
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TampicoMexicoUnknown status
CMI DNBM Dr. Pop Lavinia
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Baia MareRomaniaUnknown status
Mariodiab Clinic
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BrasovRomaniaUnknown status
Diabet Med
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BucharestRomaniaUnknown status
Sanamed Hospital
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BucharestRomaniaUnknown status
Centrul medical DiabNutriMed
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BucharestRomaniaUnknown status
Diamed Obesity
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GalațiRomaniaUnknown status
Centrul Medical Consultmed
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IașiRomaniaUnknown status
Rinart Diab SRL
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TargovisteRomaniaUnknown status
University of Colorado Anschutz Medical Campus
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AuroraUnited StatesUnknown status
Kaiser Permanente Bonita Medical Offices
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BonitaUnited StatesUnknown status
University of North Carolina Medical Center
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Chapel HillUnited StatesUnknown status
Clinical Research Professionals
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ChesterfieldUnited StatesUnknown status
Velocity Clinical Research, Dallas
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DallasUnited StatesUnknown status
AMCR Institute
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EscondidoUnited StatesUnknown status
Las Vegas Endocrinology
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HendersonUnited StatesUnknown status
Juno Research
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HoustonUnited StatesUnknown status
Southern Endocrinology Associates
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MesquiteUnited StatesUnknown status
HealthPartners Institute dba International Diabetes Center
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MinneapolisUnited StatesUnknown status
Mary & Dick Allen Diabetes Center
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Newport BeachUnited StatesUnknown status
Texas Diabetes & Endocrinology, P.A.
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Round RockUnited StatesUnknown status
San Antonio Clinical Trials
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San AntonioUnited StatesUnknown status
Clinvest Headlands LLC
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SpringfieldUnited StatesUnknown status
University Clinical Investigators, Inc.
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TustinUnited StatesUnknown status
Texas Valley Clinical Research
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WeslacoUnited StatesUnknown status
Iowa Diabetes and Endocrinology Research Center
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West Des MoinesUnited StatesUnknown status
Metabolic Research Institute, Inc
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West Palm BeachUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.