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Clinical Trials in the USA / NCT06962280
Active, not recruiting Phase 3

A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight

NCT06962280 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2025-05-12
Last updated
2026-02-17

Condition(s) studied

Type 1 DiabetesObesityOverweight

Investigational drug(s) / intervention(s)

TirzepatidePlacebo

Tirzepatide: Administered SC

Placebo: Administered SC

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * 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 had chronic or acute pancreatitis * Have used any weight loss drugs or alternative remedies, including herbal or nutritional supplements, within 90 days prior to screening

Primary outcome measure(s)

Trial sites (79)

FacilityCityRegionStatus
Kaiser Permanente Bonita Medical Offices Bonita California
AMCR Institute Escondido California
Mary & Dick Allen Diabetes Center Newport Beach California
University Clinical Investigators, Inc. Tustin California
University of Colorado Anschutz Medical Campus Aurora Colorado
Metabolic Research Institute, Inc. West Palm Beach Florida
Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa
HealthPartners Institute dba International Diabetes Center Minneapolis Minnesota
Clinical Research Professionals Chesterfield Missouri
Clinvest Headlands Llc Springfield Missouri
Las Vegas Endocrinology Henderson Nevada
University of North Carolina Medical Center Chapel Hill North Carolina
Velocity Clinical Research, Dallas Dallas Texas
Juno Research Houston Texas
Southern Endocrinology Associates Mesquite Texas
Texas Diabetes & Endocrinology, P.A. Round Rock Texas
San Antonio Clinical Trials San Antonio Texas
Texas Valley Clinical Research Weslaco Texas
Buenos Aires Macula S.A Buenos Aires Argentina
Stat Research S.A. Buenos Aires Argentina
Mautalen Salud e Investigación Buenos Aires Argentina
Centro Diabetológico Dr. Waitman Córdoba Argentina
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes Godoy Cruz Argentina
Centro de Investigaciones Clínicas Baigorria Granadero Baigorria Argentina
Instituto Médico Catamarca IMEC Rosario Argentina
Investigaciones Clínicas Tucumán San Miguel de Tucumán Argentina
Centro de Pesquisa Clinica do Brasil Brasília Brazil
Centro de Pesquisa Sao Lucas Campinas Brazil
Quanta Diagnóstico e Terapia Curitiba Brazil
Cendi - Endocrinologia e Diabetes Goiânia Brazil
Instituto da Crianca com Diabetes Porto Alegre Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica Rio de Janeiro Brazil
CPCLIN São Paulo Brazil
CEPIC - Centro Paulista de Investigação Clínica São Paulo Brazil
Endocrinologie Oasis Montreal Canada
Centricity Research Ottawa LMC Endocrinology Ottawa Canada
Centre de Recherche Saint-Louis Sherbrooke Canada
TLC Diabetes and Endocrinology Surrey Canada
Care Access - Cape Breton Sydney Canada
INTENDIA klinika s.r.o. Chrudim III Czechia

+ 39 more sites — see the full list on the official registry below.

On this site

📄 Mounjaro (tirzepatide) drug profile →

More Eli Lilly and Company trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06962280 on ClinicalTrials.gov ↗ ← All trials in the USA