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

NCT ID: NCT06914895

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

905 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-25

Study Completion Date

2027-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes Obesity Overweight

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tirzepatide

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LY3298176

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Meet the organizations funding or collaborating on the study and learn about their roles.

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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

Explore where the study is taking place and check the recruitment status at each participating site.

Sansum Diabetes Research Institute

Goleta, California, United States

Site Status RECRUITING

Care Access - Santa Clarita

Santa Clarita, California, United States

Site Status RECRUITING

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status RECRUITING

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Site Status RECRUITING

Orita Clinical Research

Decatur, Georgia, United States

Site Status RECRUITING

North Georgia Clinical Research

Woodstock, Georgia, United States

Site Status RECRUITING

East-West Medical Research Institute

Honolulu, Hawaii, United States

Site Status RECRUITING

Rocky Mountain Clinical Research

Idaho Falls, Idaho, United States

Site Status RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status RECRUITING

Indiana University Health University Hospital

Indianapolis, Indiana, United States

Site Status RECRUITING

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

Site Status RECRUITING

Endocrine and Metabolic Consultants

Rockville, Maryland, United States

Site Status RECRUITING

HealthPartners Institute dba International Diabetes Center

Minneapolis, Minnesota, United States

Site Status RECRUITING

SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, United States

Site Status RECRUITING

Boeson Research MSO

Missoula, Montana, United States

Site Status RECRUITING

Palm Research Center Tenaya

Las Vegas, Nevada, United States

Site Status RECRUITING

Palm Research Center Sunset

Las Vegas, Nevada, United States

Site Status RECRUITING

Albany Medical College, Division of Community Endocrinology

Albany, New York, United States

Site Status RECRUITING

Research Foundation of SUNY - University of Buffalo

Buffalo, New York, United States

Site Status RECRUITING

NYC Research

New York, New York, United States

Site Status RECRUITING

SUNY Upstate Medical University

Syracuse, New York, United States

Site Status RECRUITING

Lucas Research, Inc.

Morehead City, North Carolina, United States

Site Status RECRUITING

Care Access - Lima

Lima, Ohio, United States

Site Status RECRUITING

Alliance for Multispecialty Research, LLC

Norman, Oklahoma, United States

Site Status RECRUITING

Suburban Research Associates

West Chester, Pennsylvania, United States

Site Status RECRUITING

Texas Diabetes & Endocrinology, P.A.

Austin, Texas, United States

Site Status RECRUITING

Velocity Clinical Research, Dallas

Dallas, Texas, United States

Site Status RECRUITING

Tekton Research, LLC.

McKinney, Texas, United States

Site Status RECRUITING

Medrasa Clinical Research

Wylie, Texas, United States

Site Status RECRUITING

Eastside Research Associates

Redmond, Washington, United States

Site Status RECRUITING

Rainier Clinical Research Center

Renton, Washington, United States

Site Status RECRUITING

Investigaciones Medicas Imoba Srl

Buenos Aires, , Argentina

Site Status RECRUITING

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, , Argentina

Site Status RECRUITING

CIPREC

Buenos Aires, , Argentina

Site Status RECRUITING

Consultorio de Investigación Clínica EMO SRL

Buenos Aires, , Argentina

Site Status RECRUITING

CENUDIAB

Buenos Aires, , Argentina

Site Status RECRUITING

Instituto de Investigaciones Clínicas Córdoba

Córdoba, , Argentina

Site Status RECRUITING

Centro Medico Privado San Vicente Diabetes

Córdoba, , Argentina

Site Status RECRUITING

Centro de Investigaciones Médicas Mar del Plata

Mar del Plata, , Argentina

Site Status RECRUITING

Instituto Médico Río Cuarto

Río Cuarto, , Argentina

Site Status RECRUITING

Fundacion Estudios Clinicos

Rosario, , Argentina

Site Status RECRUITING

Centro de Diagnóstico y Rehabilitación (CEDIR)

Santa Fe, , Argentina

Site Status RECRUITING

Centro de Salud e Investigaciones Médicas

Santa Rosa, , Argentina

Site Status RECRUITING

Centro de Diabetes Curitiba

Curitiba, , Brazil

Site Status RECRUITING

Centro De Diabetes Metabolismo E Endocrinologia

Fortaleza, , Brazil

Site Status RECRUITING

Private Practice - Dr.Miguel N. Hissa

Fortaleza, , Brazil

Site Status RECRUITING

Universidade Federal de Goias

Goiânia, , Brazil

Site Status RECRUITING

CPQuali Pesquisa Clínica

São Paulo, , Brazil

Site Status RECRUITING

CPCLIN

São Paulo, , Brazil

Site Status RECRUITING

IBTED - Tecnologia e Educação em Diabetes

São Paulo, , Brazil

Site Status RECRUITING

CEPIC - Centro Paulista de Investigação Clínica

São Paulo, , Brazil

Site Status RECRUITING

Hospital das Clinicas FMUSP

São Paulo, , Brazil

Site Status RECRUITING

CEDOES

Vitória, , Brazil

Site Status RECRUITING

Esbjerg sygehus, Syddansk Universitetshospital

Esbjerg, , Denmark

Site Status RECRUITING

Steno Diabetes Center - Copenhagen

Herlev, , Denmark

Site Status RECRUITING

Regionshospitalet Gødstrup

Herning, , Denmark

Site Status RECRUITING

Nordsjællands Hospital - Hillerød

Hillerød, , Denmark

Site Status RECRUITING

Sjællands Universitetshospital Køge

Køge, , Denmark

Site Status RECRUITING

Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre

Caen, , France

Site Status RECRUITING

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Site Status RECRUITING

Hôtel-Dieu du Creusot - site Harfleur

Le Creusot, , France

Site Status RECRUITING

Centre du diabète DIAB-eCARE

Lyon, , France

Site Status RECRUITING

Hôpital Européen Marseille

Marseille, , France

Site Status RECRUITING

Hôpital de la Conception

Marseille, , France

Site Status RECRUITING

CHU Montpellier Lapeyronie Hospital

Montpellier, , France

Site Status RECRUITING

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

Nantes, , France

Site Status RECRUITING

Hôpital NOVO

Pontoise, , France

Site Status RECRUITING

CHU Strasbourg-Hautepierre

Strasbourg, , France

Site Status RECRUITING

Centre Hospitalier intercommunal de Toulon La Seyne sur Mer

Toulon, , France

Site Status RECRUITING

CHU Rangueil

Toulouse, , France

Site Status RECRUITING

Groupe Hospitalier Mutualiste Les Portes du Sud

Vénissieux, , France

Site Status RECRUITING

Diabetespraxis Mergentheim

Bad Mergentheim, , Germany

Site Status RECRUITING

Diabetes- und Stoffwechselpraxis Bochum

Bochum, , Germany

Site Status RECRUITING

InnoDiab Forschung Gmbh

Essen, , Germany

Site Status RECRUITING

Diabetes Zentrum Wilhelmsburg

Hamburg, , Germany

Site Status RECRUITING

Klinikum Karlsburg

Karlsburg, , Germany

Site Status RECRUITING

Universitätsklinikum Leipzig

Leipzig, , Germany

Site Status RECRUITING

Institut für Diabetesforschung GmbH Münster

Münster, , Germany

Site Status RECRUITING

RED-Institut GmbH

Oldenburg, , Germany

Site Status RECRUITING

Arztpraxis Christine Kosch Pirna

Pirna, , Germany

Site Status RECRUITING

Yitzhak Shamir Medical Center

Beer Yaacov, , Israel

Site Status RECRUITING

Soroka Medical Center

Beersheba, , Israel

Site Status RECRUITING

Rambam Health Care Campus

Haifa, , Israel

Site Status RECRUITING

Institute of Diabetes, Technology and Research - Clalit Health

Herzliya, , Israel

Site Status RECRUITING

Hadassah Medical Center

Jerusalem, , Israel

Site Status RECRUITING

Schneider Children's Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Rabin Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Diabetes Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Sourasky Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

IRCCS - AOU di Bologna

Bologna, , Italy

Site Status RECRUITING

AOU Renato Dulbecco

Catanzaro, , Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

Site Status RECRUITING

Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

University of Naples Federico II

Napoli, , Italy

Site Status RECRUITING

Azienda Ospedale - Università Padova

Padua, , Italy

Site Status RECRUITING

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

Roma, , Italy

Site Status RECRUITING

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

Torino, , Italy

Site Status RECRUITING

The Institute of Medical Science, Asahi Life Foundation

Chūōku, , Japan

Site Status RECRUITING

Matoba Internal Medicine Clinic

Ebina, , Japan

Site Status RECRUITING

Clinic Masae Minami

Fukuoka, , Japan

Site Status RECRUITING

Japanese Red Cross Fukuoka Hospital

Fukuoka, , Japan

Site Status RECRUITING

Hachioji Diabetes Clinic

Hachioji-shi, , Japan

Site Status RECRUITING

Takai Internal Medicine Clinic

Kamakura-shi, , Japan

Site Status RECRUITING

Shiraiwa Medical Clinic

Kashiwara, , Japan

Site Status RECRUITING

Kasugai Municipal Hospital

Kasugai, , Japan

Site Status RECRUITING

Kimitsu Chuo Hospital

Kisarazu, , Japan

Site Status RECRUITING

Yamanashi Prefectural Central Hospital

Kofu, , Japan

Site Status RECRUITING

Kumamoto Central Hospital - Kumamoto

Kumamoto, , Japan

Site Status RECRUITING

Jinnouchi Hospital

Kumamoto, , Japan

Site Status RECRUITING

Kure Medical Center

Kure, , Japan

Site Status RECRUITING

Mikannohana Clinic, Diabetes, Endocrinology and Metabolism

Matsuyama, , Japan

Site Status RECRUITING

Kozawa Eye Hospital and Diabetes Center

Mito, , Japan

Site Status RECRUITING

Heiwadai Hospital

Miyazaki, , Japan

Site Status RECRUITING

Soleil Chikusa Clinic

Nagoya, , Japan

Site Status RECRUITING

Tosaki Clinic for Diabetes and Endocrinology

Nagoya, , Japan

Site Status RECRUITING

Nakakinen clinic

Naka, , Japan

Site Status RECRUITING

Osaka City General Hospital

Osaka, , Japan

Site Status RECRUITING

Abe Clinic

Ōita, , Japan

Site Status RECRUITING

Odori Diabetes

Sapporo, , Japan

Site Status RECRUITING

Manda Memorial Hospital

Sapporo, , Japan

Site Status RECRUITING

Shimonoseki Medical Center

Shimonoseki, , Japan

Site Status RECRUITING

Tomonaga Clinic

Shinjuku, , Japan

Site Status RECRUITING

Suruga Clinic

Shizuoka, , Japan

Site Status RECRUITING

Tama Center Clinic Mirai

Tama, , Japan

Site Status RECRUITING

Noritake Clinic

Ushiku, , Japan

Site Status RECRUITING

Japanese Red Cross Society - Wakayama Medical Center

Wakayama, , Japan

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

Centro de Investigacion Medica de Occidente, S.C.

Guadalajara, , Mexico

Site Status RECRUITING

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

Guadalajara, , Mexico

Site Status RECRUITING

Invecordis S.C.

Hacienda de Las Palmas, , 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 NOT_YET_RECRUITING

Advanced Clinical Research, LLC

Bayamón, , Puerto Rico

Site Status RECRUITING

Manati Center for Clinical Research

Manatí, , Puerto Rico

Site Status RECRUITING

CHUAC-Complejo Hospitalario Universitario A Coruña

A Coruña, , Spain

Site Status RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status RECRUITING

Hospital Clínic de Barcelona

Barcelona, , Spain

Site Status RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval

Ferrol, , Spain

Site Status RECRUITING

Hospital Universitario de Móstoles

Móstoles, , Spain

Site Status RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Site Status RECRUITING

Hospital Universitario Virgen Del Rocio

Seville, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

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

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

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

Find local site contact details for specific facilities participating in the trial.

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Related Links

Access external resources that provide additional context or updates about the study.

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

Review additional registry numbers or institutional identifiers associated with this trial.

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