AzTrials
AzTrials

Type 1 DiabetesPhase 3SURPASS-T1D-1NCT06914895

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

A Phase 3 study testing Tirzepatide in people with Type 1 Diabetes and Obesity, run by Eli Lilly and Company at 146 sites in 12 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes, Obesity, Overweight
What is being tested?
Tirzepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
905 participants
Where
146 sitesin 12 countries
Study dates
25 Apr 2025to Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

146 sites in 12 countries.

146 sites in 12 countries

United States31 sites

  • Albany Medical College, Division of Community Endocrinology

    Albany, New York, 12203

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas, 78731

  • Research Foundation of SUNY - University of Buffalo

    Buffalo, New York, 14221

  • Velocity Clinical Research, Dallas

    Dallas, Texas, 75230

  • Orita Clinical Research

    Decatur, Georgia, 30034

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho, 83404

  • Indiana University Health University Hospital

    Indianapolis, Indiana, 46202

  • Palm Research Center Tenaya

    Las Vegas, Nevada, 89128

  • Palm Research Center Sunset

    Las Vegas, Nevada, 89148

  • Care Access - Lima

    Lima, Ohio, 45805

  • Tekton Research, LLC.

    McKinney, Texas, 75069

  • HealthPartners Institute dba International Diabetes Center

    Minneapolis, Minnesota, 55416

  • Boeson Research MSO

    Missoula, Montana, 59804

  • Lucas Research, Inc.

    Morehead City, North Carolina, 28557

  • NYC Research

    New York, New York, 10016

  • Alliance for Multispecialty Research, LLC

    Norman, Oklahoma, 73069

  • Eastside Research Associates

    Redmond, Washington, 98052

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland, Mississippi, 39157

  • Endocrine and Metabolic Consultants

    Rockville, Maryland, 20852

  • Sansum Diabetes Research Institute

    Santa Barbara, California, 93105

  • Care Access - Santa Clarita

    Santa Clarita, California, 91321

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Suburban Research Associates

    West Chester, Pennsylvania, 19380

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50266

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

  • Medrasa Clinical Research

    Wylie, Texas, 75098

Other trials in United States

Japan29 sites

  • The Institute of Medical Science, Asahi Life Foundation

    Chūōku, 103-0002

  • Matoba Internal Medicine Clinic

    Ebina, 243-0432

  • Clinic Masae Minami

    Fukuoka, 815-0071

  • Japanese Red Cross Fukuoka Hospital

    Fukuoka, 815-8555

  • Hachioji Diabetes Clinic

    Hachioji-shi, 192-0083

  • Takai Internal Medicine Clinic

    Kamakura-shi, 247-0056

  • Shiraiwa Medical Clinic

    Kashiwara, 582-0005

  • Kasugai Municipal Hospital

    Kasugai, 486-8510

  • Kimitsu Chuo Hospital

    Kisarazu, 292-8535

  • Yamanashi Prefectural Central Hospital

    Kofu, 400-8506

  • Kumamoto Central Hospital - Kumamoto

    Kumamoto, 862-0965

  • Jinnouchi Hospital

    Kumamoto, 862-0976

  • Kure Medical Center

    Kure, 737-0023

  • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism

    Matsuyama, 790-0034

  • Kozawa Eye Hospital and Diabetes Center

    Mito, 310-0845

  • Heiwadai Hospital

    Miyazaki, 880-0034

  • Soleil Chikusa Clinic

    Nagoya, 464-0858

  • Tosaki Clinic for Diabetes and Endocrinology

    Nagoya, 468-0009

  • Nakakinen clinic

    Naka, 311-0113

  • Abe Clinic

    Ōita, 870-0039

  • Osaka City General Hospital

    Osaka, 534-0021

  • Odori Diabetes

    Sapporo, 060-0001

  • Manda Memorial Hospital

    Sapporo, 060-0062

  • Shimonoseki Medical Center

    Shimonoseki, 750-0061

  • Tomonaga Clinic

    Shinjuku, 160-0022

  • Suruga Clinic

    Shizuoka, 424-0855

  • Tama Center Clinic Mirai

    Tama, 206-0033

  • Noritake Clinic

    Ushiku, 300-1207

  • Japanese Red Cross Society - Wakayama Medical Center

    Wakayama, 640-8558

Other trials in Japan

France13 sites

  • Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre

    Caen, 14033

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91106

  • Hôtel-Dieu du Creusot - site Harfleur

    Le Creusot, 71200

  • Centre du diabète DIAB-eCARE

    Lyon, 69008

  • Hôpital Européen Marseille

    Marseille, 13003

  • Hôpital de la Conception

    Marseille, 13005

  • CHU Montpellier Lapeyronie Hospital

    Montpellier, 34295

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

    Nantes, 44093

  • Hôpital NOVO

    Pontoise, 95300

  • CHU Strasbourg-Hautepierre

    Strasbourg, 67098

  • Centre Hospitalier intercommunal de Toulon La Seyne sur Mer

    Toulon, 83100

  • CHU Rangueil

    Toulouse, 31059

  • Groupe Hospitalier Mutualiste Les Portes du Sud

    Vénissieux, 69200

Other trials in France

Argentina12 sites

  • Investigaciones Medicas Imoba Srl

    Buenos Aires, C1056ABH

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1056ABI

  • CIPREC

    Buenos Aires, C1119ACN

  • Consultorio de Investigación Clínica EMO SRL

    Buenos Aires, C1405BUB

  • CENUDIAB

    Buenos Aires, C1440AAD

  • Instituto de Investigaciones Clínicas Córdoba

    Córdoba, 5000

  • Centro Medico Privado San Vicente Diabetes

    Córdoba, 5006

  • Centro de Investigaciones Médicas Mar del Plata

    Mar del Plata, 7600

  • Instituto Médico Río Cuarto

    Río Cuarto, X5800AEV

  • Fundacion Estudios Clinicos

    Rosario, 2000

  • Centro de Diagnóstico y Rehabilitación (CEDIR)

    Santa Fe, 3000

  • Centro de Salud e Investigaciones Médicas

    Santa Rosa, L6300

Other trials in Argentina

Brazil10 sites

  • Centro de Diabetes Curitiba

    Curitiba, 80810-040

  • Centro De Diabetes Metabolismo E Endocrinologia

    Fortaleza, 60175-047

  • Private Practice - Dr.Miguel N. Hissa

    Fortaleza, 60430-350

  • Universidade Federal de Goias

    Goiânia, 74605-020

  • CPQuali Pesquisa Clínica

    São Paulo, 01228-000

  • CPCLIN

    São Paulo, 01228-200

  • IBTED - Tecnologia e Educação em Diabetes

    São Paulo, 04038-032

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, 04266-010

  • Hospital das Clinicas FMUSP

    São Paulo, 05403-000

  • CEDOES

    Vitória, 29055450

Other trials in Brazil

Israel10 sites

  • Yitzhak Shamir Medical Center

    Beer Yaacov, 70300

  • Soroka Medical Center

    Beersheba, 8410101

  • Rambam Health Care Campus

    Haifa, 3109601

  • Institute of Diabetes, Technology and Research - Clalit Health

    Herzliya, 4600201

  • Hadassah Medical Center

    Jerusalem, 9112001

  • Schneider Children's Medical Center

    Petah Tikva, 4920235

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Sheba Medical Center

    Ramat Gan, 5262100

  • Diabetes Medical Center

    Tel Aviv, 51549

  • Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Germany9 sites

  • Diabetespraxis Mergentheim

    Bad Mergentheim, 97980

  • Diabetes- und Stoffwechselpraxis Bochum

    Bochum, 44869

  • InnoDiab Forschung Gmbh

    Essen, 45136

  • Diabetes Zentrum Wilhelmsburg

    Hamburg, 21109

  • Klinikum Karlsburg

    Karlsburg, 17495

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Institut für Diabetesforschung GmbH Münster

    Münster, 48145

  • RED-Institut GmbH

    Oldenburg, 23758

  • Arztpraxis Christine Kosch Pirna

    Pirna, 01796

Other trials in Germany

Mexico9 sites

  • Enclifar Ensayos Clínicos Farmacológicos Sc

    Chihuahua City, 31110

  • Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente

    Guadalajara, 44150

  • Centro de Investigacion Medica de Occidente, S.C.

    Guadalajara, 44260

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

    Guadalajara, 44670

  • Invecordis S.C.

    Hacienda de Las Palmas, 52763

  • CEINV Salud

    Monterrey, 64020

  • Clínica García Flores SC

    Monterrey, 64610

  • Consultorio Médico de Endocrinología y Pediatría

    Puebla City, 72190

  • Medsal Centro Médico

    Tampico, 89210

Other trials in Mexico

Italy8 sites

  • IRCCS - AOU di Bologna

    Bologna, 40138

  • AOU Renato Dulbecco

    Catanzaro, 88100

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

  • Ospedale San Raffaele

    Milan, 20132

  • University of Naples Federico II

    Naples, 80100

  • Azienda Ospedale - Università Padova

    Padova, 35128

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

    Roma, 00168

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

    Torino, 10126

Other trials in Italy

Spain8 sites

  • CHUAC-Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval

    Ferrol, 15405

  • Hospital Universitario de Móstoles

    Móstoles, 28935

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

Other trials in Spain

Denmark5 sites

  • Esbjerg sygehus, Syddansk Universitetshospital

    Esbjerg, 6700

  • Steno Diabetes Center - Copenhagen

    Herlev, 2730

  • Regionshospitalet Gødstrup

    Herning, 7400

  • Nordsjællands Hospital - Hillerød

    Hillerød, 3400

  • Sjællands Universitetshospital Køge

    Køge, 4600

Other trials in Denmark

Puerto Rico2 sites

  • Advanced Clinical Research, LLC

    Bayamón, 00959

  • Manati Center for Clinical Research

    Manati, 00674

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Tirzepatide Once Weekly Compared to Placebo in Adult Participants With Type 1 Diabetes and Obesity or Overweight

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.

Being tested
Tirzepatide, Placebo
Medical subject headings
Diabetes Mellitus, Type 1, Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TirzepatideDrug

    Also called LY3298176

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT06914895
Study groupRoleWhat they receive
Tirzepatide Dose 1ExperimentalParticipants will receive tirzepatide subcutaneously (SC)
Receives: Drug: Tirzepatide
Tirzepatide Dose 2ExperimentalParticipants will receive tirzepatide SC
Receives: Drug: Tirzepatide
Tirzepatide Dose 3ExperimentalParticipants will receive tirzepatide SC
Receives: Drug: Tirzepatide
Tirzepatide Dose 4ExperimentalParticipants will receive tirzepatide SC
Receives: Drug: Tirzepatide
PlaceboPlacebo comparatorParticipants will receive placebo SC
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Hemoglobin A1c (HbA1c)

    Measured: Baseline, Week 40

Secondary outcomes (13)

  1. Percentage of Time Continuous Glucose Monitor (CGM) Glucose Values are Between 70 and 180 milligrams per deciliter (mg/dL) (3.9 and 10.0 millimoles per liter (mmol/L) Inclusive, Per Day

    Measured: Within 30 days prior to Week 40

  2. Change from Baseline in Body Weight

    Measured: Baseline, Week 40

  3. Percent Change from Baseline in Body Weight

    Measured: Baseline, Week 40

  4. Percentage of Participants with ≥5% Body Weight Reduction

    Measured: Baseline, Week 40

  5. Percentage of Participants with ≥10% Body Weight Reduction

    Measured: Baseline, Week 40

  6. Percentage of Participants with ≥15% Body Weight Reduction

    Measured: Baseline, Week 40

  7. Change from Baseline in Waist Circumference

    Measured: Baseline, Week 40

  8. Change from Baseline in Systolic Blood Pressure (SBP)

    Measured: Baseline, Week 40

  9. Percent Change from Baseline in Fasting Triglycerides

    Measured: Baseline, Week 40

  10. Percent Change from Baseline in Fasting Non-High-Density Lipoprotein (non-HDL) Cholesterol

    Measured: Baseline, Week 40

  11. Percent Change from Baseline in Total Daily Insulin Dose

    Measured: Baseline, Week 40

  12. Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)

    Measured: Baseline, Week 40

  13. Change from Baseline in EQ-5D-5L

    Measured: Baseline, Week 40

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2025
  2. Study start25 Apr 2025
  3. Primary completionNov 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
905 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06914895
Sponsor's protocol ID
27285
Other IDs
I8F-MC-GPJA, 2024-519684-17-00
Acronym
SURPASS-T1D-1
Status last verified
May 2026
First submitted
4 Apr 2025
Last updated
12 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tirzepatide in people with Type 1 Diabetes and Obesity, run by Eli Lilly and Company at 146 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 146 sites in United States, Japan, France, Argentina, Brazil and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 40). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06914895.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in