A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight

NCT ID: NCT06914895

Last Updated: 2026-02-17

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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

905 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-25

Study Completion Date

2026-12-31

Brief Summary

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The main purpose of this study is to find out how well and how safely tirzepatide works in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 49 weeks.

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 Dose 1

Participants will receive tirzepatide subcutaneously (SC)

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC

Tirzepatide Dose 2

Participants will receive tirzepatide SC

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC

Tirzepatide Dose 3

Participants will receive tirzepatide SC

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC

Tirzepatide Dose 4

Participants will receive tirzepatide 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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Sansum Diabetes Research Institute

Santa Barbara, California, United States

Site Status

Care Access - Santa Clarita

Santa Clarita, California, United States

Site Status

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Site Status

Orita Clinical Research

Decatur, Georgia, United States

Site Status

North Georgia Clinical Research

Woodstock, Georgia, United States

Site Status

East-West Medical Research Institute

Honolulu, Hawaii, United States

Site Status

Rocky Mountain Clinical Research

Idaho Falls, Idaho, United States

Site Status

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status

Indiana University Health University Hospital

Indianapolis, Indiana, United States

Site Status

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

Site Status

Endocrine and Metabolic Consultants

Rockville, Maryland, United States

Site Status

HealthPartners Institute dba International Diabetes Center

Minneapolis, Minnesota, United States

Site Status

SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, United States

Site Status

Boeson Research MSO

Missoula, Montana, United States

Site Status

Palm Research Center Tenaya

Las Vegas, Nevada, United States

Site Status

Palm Research Center Sunset

Las Vegas, Nevada, United States

Site Status

Albany Medical College, Division of Community Endocrinology

Albany, New York, United States

Site Status

Research Foundation of SUNY - University of Buffalo

Buffalo, New York, United States

Site Status

NYC Research

New York, New York, United States

Site Status

SUNY Upstate Medical University

Syracuse, New York, United States

Site Status

Lucas Research, Inc.

Morehead City, North Carolina, United States

Site Status

Care Access - Lima

Lima, Ohio, United States

Site Status

Alliance for Multispecialty Research, LLC

Norman, Oklahoma, United States

Site Status

Suburban Research Associates

West Chester, Pennsylvania, United States

Site Status

Texas Diabetes & Endocrinology, P.A.

Austin, Texas, United States

Site Status

Velocity Clinical Research, Dallas

Dallas, Texas, United States

Site Status

Tekton Research, LLC.

McKinney, Texas, United States

Site Status

Medrasa Clinical Research

Wylie, Texas, United States

Site Status

Eastside Research Associates

Redmond, Washington, United States

Site Status

Rainier Clinical Research Center

Renton, Washington, United States

Site Status

Investigaciones Medicas Imoba Srl

Buenos Aires, , Argentina

Site Status

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, , Argentina

Site Status

CIPREC

Buenos Aires, , Argentina

Site Status

Consultorio de Investigación Clínica EMO SRL

Buenos Aires, , Argentina

Site Status

CENUDIAB

Buenos Aires, , Argentina

Site Status

Instituto de Investigaciones Clínicas Córdoba

Córdoba, , Argentina

Site Status

Centro Medico Privado San Vicente Diabetes

Córdoba, , Argentina

Site Status

Centro de Investigaciones Médicas Mar del Plata

Mar del Plata, , Argentina

Site Status

Instituto Médico Río Cuarto

Río Cuarto, , Argentina

Site Status

Fundacion Estudios Clinicos

Rosario, , Argentina

Site Status

Centro de Diagnóstico y Rehabilitación (CEDIR)

Santa Fe, , Argentina

Site Status

Centro de Salud e Investigaciones Médicas

Santa Rosa, , Argentina

Site Status

Centro de Diabetes Curitiba

Curitiba, , Brazil

Site Status

Centro De Diabetes Metabolismo E Endocrinologia

Fortaleza, , Brazil

Site Status

Private Practice - Dr.Miguel N. Hissa

Fortaleza, , Brazil

Site Status

Universidade Federal de Goias

Goiânia, , Brazil

Site Status

CPQuali Pesquisa Clínica

São Paulo, , Brazil

Site Status

CPCLIN

São Paulo, , Brazil

Site Status

IBTED - Tecnologia e Educação em Diabetes

São Paulo, , Brazil

Site Status

CEPIC - Centro Paulista de Investigação Clínica

São Paulo, , Brazil

Site Status

Hospital das Clinicas FMUSP

São Paulo, , Brazil

Site Status

CEDOES

Vitória, , Brazil

Site Status

Esbjerg sygehus, Syddansk Universitetshospital

Esbjerg, , Denmark

Site Status

Steno Diabetes Center - Copenhagen

Herlev, , Denmark

Site Status

Regionshospitalet Gødstrup

Herning, , Denmark

Site Status

Nordsjællands Hospital - Hillerød

Hillerød, , Denmark

Site Status

Sjællands Universitetshospital Køge

Køge, , Denmark

Site Status

Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre

Caen, , France

Site Status

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Site Status

Hôtel-Dieu du Creusot - site Harfleur

Le Creusot, , France

Site Status

Centre du diabète DIAB-eCARE

Lyon, , France

Site Status

Hôpital Européen Marseille

Marseille, , France

Site Status

Hôpital de la Conception

Marseille, , France

Site Status

CHU Montpellier Lapeyronie Hospital

Montpellier, , France

Site Status

Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes

Nantes, , France

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Hôpital NOVO

Pontoise, , France

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CHU Strasbourg-Hautepierre

Strasbourg, , France

Site Status

Centre Hospitalier intercommunal de Toulon La Seyne sur Mer

Toulon, , France

Site Status

CHU Rangueil

Toulouse, , France

Site Status

Groupe Hospitalier Mutualiste Les Portes du Sud

Vénissieux, , France

Site Status

Diabetespraxis Mergentheim

Bad Mergentheim, , Germany

Site Status

Diabetes- und Stoffwechselpraxis Bochum

Bochum, , Germany

Site Status

InnoDiab Forschung Gmbh

Essen, , Germany

Site Status

Diabetes Zentrum Wilhelmsburg

Hamburg, , Germany

Site Status

Klinikum Karlsburg

Karlsburg, , Germany

Site Status

Universitätsklinikum Leipzig

Leipzig, , Germany

Site Status

Institut für Diabetesforschung GmbH Münster

Münster, , Germany

Site Status

RED-Institut GmbH

Oldenburg, , Germany

Site Status

Arztpraxis Christine Kosch Pirna

Pirna, , Germany

Site Status

Yitzhak Shamir Medical Center

Beer Yaacov, , Israel

Site Status

Soroka Medical Center

Beersheba, , Israel

Site Status

Rambam Health Care Campus

Haifa, , Israel

Site Status

Institute of Diabetes, Technology and Research - Clalit Health

Herzliya, , Israel

Site Status

Hadassah Medical Center

Jerusalem, , Israel

Site Status

Schneider Children's Medical Center

Petah Tikva, , Israel

Site Status

Rabin Medical Center

Petah Tikva, , Israel

Site Status

Sheba Medical Center

Ramat Gan, , Israel

Site Status

Diabetes Medical Center

Tel Aviv, , Israel

Site Status

Sourasky Medical Center

Tel Aviv, , Israel

Site Status

IRCCS - AOU di Bologna

Bologna, , Italy

Site Status

AOU Renato Dulbecco

Catanzaro, , Italy

Site Status

Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

Site Status

Ospedale San Raffaele

Milan, , Italy

Site Status

University of Naples Federico II

Napoli, , Italy

Site Status

Azienda Ospedale - Università Padova

Padua, , Italy

Site Status

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

Roma, , Italy

Site Status

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

Torino, , Italy

Site Status

The Institute of Medical Science, Asahi Life Foundation

Chūōku, , Japan

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Matoba Internal Medicine Clinic

Ebina, , Japan

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Clinic Masae Minami

Fukuoka, , Japan

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Japanese Red Cross Fukuoka Hospital

Fukuoka, , Japan

Site Status

Hachioji Diabetes Clinic

Hachioji-shi, , Japan

Site Status

Takai Internal Medicine Clinic

Kamakura-shi, , Japan

Site Status

Shiraiwa Medical Clinic

Kashiwara, , Japan

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Kasugai Municipal Hospital

Kasugai, , Japan

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Kimitsu Chuo Hospital

Kisarazu, , Japan

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Yamanashi Prefectural Central Hospital

Kofu, , Japan

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Kumamoto Central Hospital - Kumamoto

Kumamoto, , Japan

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Jinnouchi Hospital

Kumamoto, , Japan

Site Status

Kure Medical Center

Kure, , Japan

Site Status

Mikannohana Clinic, Diabetes, Endocrinology and Metabolism

Matsuyama, , Japan

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Kozawa Eye Hospital and Diabetes Center

Mito, , Japan

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Heiwadai Hospital

Miyazaki, , Japan

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Soleil Chikusa Clinic

Nagoya, , Japan

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Tosaki Clinic for Diabetes and Endocrinology

Nagoya, , Japan

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Nakakinen clinic

Naka, , Japan

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Osaka City General Hospital

Osaka, , Japan

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Abe Clinic

Ōita, , Japan

Site Status

Odori Diabetes

Sapporo, , Japan

Site Status

Manda Memorial Hospital

Sapporo, , Japan

Site Status

Shimonoseki Medical Center

Shimonoseki, , Japan

Site Status

Tomonaga Clinic

Shinjuku, , Japan

Site Status

Suruga Clinic

Shizuoka, , Japan

Site Status

Tama Center Clinic Mirai

Tama, , Japan

Site Status

Noritake Clinic

Ushiku, , Japan

Site Status

Japanese Red Cross Society - Wakayama Medical Center

Wakayama, , Japan

Site Status

Enclifar Ensayos Clínicos Farmacológicos Sc

Chihuahua City, , Mexico

Site Status

Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente

Guadalajara, , Mexico

Site Status

Centro de Investigacion Medica de Occidente, S.C.

Guadalajara, , Mexico

Site Status

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

Guadalajara, , Mexico

Site Status

Invecordis S.C.

Hacienda de Las Palmas, , Mexico

Site Status

CEINV Salud

Monterrey, , Mexico

Site Status

Clínica García Flores SC

Monterrey, , Mexico

Site Status

Consultorio Médico de Endocrinología y Pediatría

Puebla City, , Mexico

Site Status

Medsal Centro Médico

Tampico, , Mexico

Site Status

Advanced Clinical Research, LLC

Bayamón, , Puerto Rico

Site Status

Manati Center for Clinical Research

Manatí, , Puerto Rico

Site Status

CHUAC-Complejo Hospitalario Universitario A Coruña

A Coruña, , Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Clínic de Barcelona

Barcelona, , Spain

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval

Ferrol, , Spain

Site Status

Hospital Universitario de Móstoles

Móstoles, , Spain

Site Status

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Site Status

Hospital Universitario Virgen Del Rocio

Seville, , Spain

Site Status

Countries

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United States Argentina Brazil Denmark France Germany Israel Italy Japan Mexico Puerto Rico Spain

Related Links

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https://trials.lilly.com/en-US/trial/589916

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

Other Identifiers

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I8F-MC-GPJA

Identifier Type: OTHER

Identifier Source: secondary_id

2024-519684-17-00

Identifier Type: CTIS

Identifier Source: secondary_id

27285

Identifier Type: -

Identifier Source: org_study_id

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