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

NCT ID: NCT06962280

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

465 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-12

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tirzepatide

Participants will receive tirzepatide subcutaneously (SC)

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC

Placebo

Participants will receive placebo SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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Tirzepatide

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY3298176

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Kaiser Permanente Bonita Medical Offices

Bonita, California, United States

Site Status RECRUITING

AMCR Institute

Escondido, California, United States

Site Status RECRUITING

Mary & Dick Allen Diabetes Center

Newport Beach, California, United States

Site Status RECRUITING

University Clinical Investigators, Inc.

Tustin, California, United States

Site Status RECRUITING

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status RECRUITING

Metabolic Research Institute, Inc.

West Palm Beach, Florida, United States

Site Status RECRUITING

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

Site Status RECRUITING

HealthPartners Institute dba International Diabetes Center

Minneapolis, Minnesota, United States

Site Status RECRUITING

Clinical Research Professionals

Chesterfield, Missouri, United States

Site Status RECRUITING

Clinvest Headlands Llc

Springfield, Missouri, United States

Site Status RECRUITING

Las Vegas Endocrinology

Henderson, Nevada, United States

Site Status RECRUITING

University of North Carolina Medical Center

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Velocity Clinical Research, Dallas

Dallas, Texas, United States

Site Status RECRUITING

Juno Research

Houston, Texas, United States

Site Status RECRUITING

Southern Endocrinology Associates

Mesquite, Texas, United States

Site Status RECRUITING

Texas Diabetes & Endocrinology, P.A.

Round Rock, Texas, United States

Site Status RECRUITING

San Antonio Clinical Trials

San Antonio, Texas, United States

Site Status RECRUITING

Texas Valley Clinical Research

Weslaco, Texas, United States

Site Status RECRUITING

Buenos Aires Macula S.A

Buenos Aires, , Argentina

Site Status RECRUITING

Stat Research S.A.

Buenos Aires, , Argentina

Site Status RECRUITING

Mautalen Salud e Investigación

Buenos Aires, , Argentina

Site Status RECRUITING

Centro Diabetológico Dr. Waitman

Córdoba, , Argentina

Site Status RECRUITING

CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

Godoy Cruz, , Argentina

Site Status RECRUITING

Centro de Investigaciones Clínicas Baigorria

Granadero Baigorria, , Argentina

Site Status RECRUITING

Instituto Médico Catamarca IMEC

Rosario, , Argentina

Site Status RECRUITING

Investigaciones Clínicas Tucumán

San Miguel de Tucumán, , Argentina

Site Status RECRUITING

Centro de Pesquisa Clinica do Brasil

Brasília, , Brazil

Site Status RECRUITING

Centro de Pesquisa Sao Lucas

Campinas, , Brazil

Site Status RECRUITING

Quanta Diagnóstico e Terapia

Curitiba, , Brazil

Site Status RECRUITING

Cendi - Endocrinologia e Diabetes

Goiânia, , Brazil

Site Status RECRUITING

Instituto da Crianca com Diabetes

Porto Alegre, , Brazil

Site Status RECRUITING

IBPClin - Instituto Brasil de Pesquisa Clínica

Rio de Janeiro, , Brazil

Site Status RECRUITING

CPCLIN

São Paulo, , Brazil

Site Status RECRUITING

CEPIC - Centro Paulista de Investigação Clínica

São Paulo, , Brazil

Site Status RECRUITING

Endocrinologie Oasis

Montreal, , Canada

Site Status RECRUITING

Centricity Research Ottawa LMC Endocrinology

Ottawa, , Canada

Site Status RECRUITING

Centre de Recherche Saint-Louis

Sherbrooke, , Canada

Site Status RECRUITING

TLC Diabetes and Endocrinology

Surrey, , Canada

Site Status RECRUITING

Care Access - Cape Breton

Sydney, , Canada

Site Status RECRUITING

INTENDIA klinika s.r.o.

Chrudim III, , Czechia

Site Status RECRUITING

AIDIN VK s.r.o.

Hranice, , Czechia

Site Status ACTIVE_NOT_RECRUITING

MUDr. Tomas Edelsberger

Krnov, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Diabetologicke centrum s.r.o.

Olomouc, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Milan Kvapil s.r.o., Diabetologicka ambulance

Prague, , Czechia

Site Status RECRUITING

ResTrial s.r.o.

Prague, , Czechia

Site Status ACTIVE_NOT_RECRUITING

Centre Hospitalier Universitaire - Hôpitaux de Rouen - Hôpital de Bois-Guillaume

Bois-Guillaume, , France

Site Status RECRUITING

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Grenoble

Grenoble, , France

Site Status RECRUITING

Hôtel-Dieu du Creusot - site Harfleur

Le Creusot, , France

Site Status RECRUITING

Hôpital de la Conception

Marseille, , France

Site Status RECRUITING

Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière

Paris, , France

Site Status RECRUITING

CHU Rangueil

Toulouse, , France

Site Status RECRUITING

Groupe Hospitalier Mutualiste Les Portes du Sud

Vénissieux, , France

Site Status RECRUITING

Athens Medical Center

Athens, , Greece

Site Status RECRUITING

Iatriko Paleou Falirou Medical Center

Palaió Fáliro, , Greece

Site Status RECRUITING

Euromedica General Clinic of Thessaloniki

Thessaloniki, , Greece

Site Status RECRUITING

Ippokrateio General Hospital of Thessaloniki

Thessaloniki, , Greece

Site Status RECRUITING

Enclifar Ensayos Clínicos Farmacológicos Sc

Chihuahua City, , Mexico

Site Status RECRUITING

Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente

Guadalajara, , Mexico

Site Status RECRUITING

Private Practice - Dr. Arechavaleta Granell Maria del Rosario

Guadalajara, , Mexico

Site Status RECRUITING

Unidad de Investigación Clínica y Atención Médica HEPA S.C.

Guadalajara, , Mexico

Site Status RECRUITING

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, , Mexico

Site Status RECRUITING

CEINV Salud

Monterrey, , Mexico

Site Status RECRUITING

Clínica García Flores SC

Monterrey, , Mexico

Site Status RECRUITING

Consultorio Médico de Endocrinología y Pediatría

Puebla City, , Mexico

Site Status RECRUITING

Medsal Centro Médico

Tampico, , Mexico

Site Status RECRUITING

CMI DNBM Dr. Pop Lavinia

Baia Mare, , Romania

Site Status RECRUITING

Mariodiab Clinic

Brasov, , Romania

Site Status RECRUITING

Centrul medical DiabNutriMed

Bucharest, , Romania

Site Status RECRUITING

Diabet Med

Bucharest, , Romania

Site Status RECRUITING

Sanamed Hospital

Bucharest, , Romania

Site Status RECRUITING

Diamed Obesity

Galați, , Romania

Site Status RECRUITING

Centrul Medical Consultmed

Iași, , Romania

Site Status RECRUITING

Rinart Diab SRL

Târgovişte, , Romania

Site Status RECRUITING

Hospital Infanta Cristina

Badajoz, , Spain

Site Status RECRUITING

Hospital Germans Trias i Pujol

Badalona, , Spain

Site Status RECRUITING

Hospital Clínic de Barcelona

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Virgen Del Rocio

Seville, , Spain

Site Status RECRUITING

Countries

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United States Argentina Brazil Canada Czechia France Greece Mexico Romania Spain

Central Contacts

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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Role: CONTACT

Phone: 1-317-615-4559

Email: [email protected]

Physicians interested in becoming principal investigators please contact

Role: CONTACT

Email: [email protected]

Facility Contacts

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Related Links

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https://trials.lilly.com/en-US/trial/605555

A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight (SURPASS-T1D-2)

Other Identifiers

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2024-519685-51-00

Identifier Type: CTIS

Identifier Source: secondary_id

I8F-MC-GPJD

Identifier Type: OTHER

Identifier Source: secondary_id

27340

Identifier Type: -

Identifier Source: org_study_id