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Type 1 DiabetesPhase 3SURPASS-T1D-2NCT06962280

A Long-Term Study of Tirzepatide (LY3298176) 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 79 sites in 10 countries.

Active, not recruiting

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

Official record
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Trial 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. 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
465 participants
Where
79 sitesin 10 countries
Study dates
12 May 2025to Jul 2027
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

79 sites in 10 countries.

79 sites in 10 countries

United States18 sites

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Kaiser Permanente Bonita Medical Offices

    Bonita, California, 91902

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina, 27514

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • Velocity Clinical Research, Dallas

    Dallas, Texas, 75230

  • AMCR Institute

    Escondido, California, 92025

  • Las Vegas Endocrinology

    Henderson, Nevada, 89074

  • Juno Research

    Houston, Texas, 77040

  • Southern Endocrinology Associates

    Mesquite, Texas, 75149

  • HealthPartners Institute dba International Diabetes Center

    Minneapolis, Minnesota, 55416

  • Mary & Dick Allen Diabetes Center

    Newport Beach, California, 92663

  • Texas Diabetes & Endocrinology, P.A.

    Round Rock, Texas, 78681

  • San Antonio Clinical Trials

    San Antonio, Texas, 78240

  • Clinvest Headlands Llc

    Springfield, Missouri, 65807

  • University Clinical Investigators, Inc.

    Tustin, California, 92780

  • Texas Valley Clinical Research

    Weslaco, Texas, 78596

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50266

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida, 33401

Other trials in United States

Mexico9 sites

  • Enclifar Ensayos Clínicos Farmacológicos Sc

    Chihuahua City, 31110

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

    Guadalajara, 44150

  • Private Practice - Dr. Arechavaleta Granell Maria del Rosario

    Guadalajara, 44670

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

    Guadalajara, 44670

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, 14080

  • 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

Argentina8 sites

  • Buenos Aires Macula S.A

    Buenos Aires, 1061

  • Stat Research S.A.

    Buenos Aires, C1023AAB

  • Mautalen Salud e Investigación

    Buenos Aires, C1128AAF

  • Centro Diabetológico Dr. Waitman

    Córdoba, 5000

  • CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

    Godoy Cruz, M5501ARP

  • Centro de Investigaciones Clínicas Baigorria

    Granadero Baigorria, 2152

  • Instituto Médico Catamarca IMEC

    Rosario, 2000

  • Investigaciones Clínicas Tucumán

    San Miguel de Tucumán, T4000ICL

Other trials in Argentina

Brazil8 sites

  • Centro de Pesquisa Clinica do Brasil

    Brasília, 71625-175

  • Centro de Pesquisa Sao Lucas

    Campinas, 13060-803

  • Quanta Diagnóstico e Terapia

    Curitiba, 80045170

  • Cendi - Endocrinologia e Diabetes

    Goiânia, 74230-035

  • Instituto da Crianca com Diabetes

    Porto Alegre, 91350-250

  • IBPClin - Instituto Brasil de Pesquisa Clínica

    Rio de Janeiro, 20241-180

  • CPCLIN

    São Paulo, 01228-200

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, 04266-010

Other trials in Brazil

France8 sites

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

    Bois-Guillaume, 76230

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91106

  • Centre Hospitalier Universitaire de Grenoble

    Grenoble, 38700

  • Hôtel-Dieu du Creusot - site Harfleur

    Le Creusot, 71200

  • Hôpital de la Conception

    Marseille, 13005

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

    Paris, 75010

  • CHU Rangueil

    Toulouse, 31059

  • Groupe Hospitalier Mutualiste Les Portes du Sud

    Vénissieux, 69200

Other trials in France

Romania8 sites

  • CMI DNBM Dr. Pop Lavinia

    Baia Mare, 430222

  • Mariodiab Clinic

    Brasov, 500097

  • Centrul medical DiabNutriMed

    Bucharest, 020359

  • Diabet Med

    Bucharest, 050913

  • Sanamed Hospital

    Bucharest, 060013

  • Diamed Obesity

    Galați, 800291

  • Centrul Medical Consultmed

    Iași, 700547

  • Rinart Diab SRL

    Targoviste, 130168

Other trials in Romania

Czechia6 sites

  • INTENDIA klinika s.r.o.

    Chrudim III, 537 01

  • AIDIN VK s.r.o.

    Hranice, 753 01

  • MUDr. Tomas Edelsberger

    Krnov, 79401

  • Diabetologicke centrum s.r.o.

    Olomouc, 779 00

  • Milan Kvapil s.r.o., Diabetologicka ambulance

    Prague, 14900

  • ResTrial s.r.o.

    Prague, 18100

Other trials in Czechia

Canada5 sites

  • Endocrinologie Oasis

    Montreal, H4J 1E3

  • Centricity Research Ottawa LMC Endocrinology

    Ottawa, K2J 0V2

  • Centre de Recherche Saint-Louis

    Sherbrooke, J1G 1X9

  • TLC Diabetes and Endocrinology

    Surrey, V3T 2V6

  • Care Access - Cape Breton

    Sydney, B1M 0A1

Other trials in Canada

Spain5 sites

  • Hospital Infanta Cristina

    Badajoz, 06080

  • Hospital Germans Trias i Pujol

    Badalona, 08916

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

Other trials in Spain

Greece4 sites

  • Athens Medical Center

    Athens, 151 25

  • Iatriko Paleou Falirou Medical Center

    Palaió Fáliro, 17562

  • Euromedica General Clinic of Thessaloniki

    Thessaloniki, 546 45

  • Ippokrateio General Hospital of Thessaloniki

    Thessaloniki, 54642

Other trials in Greece

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Long-Term Safety of Tirzepatide Once Weekly Compared to Placebo in Adults 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 long-term in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 20 months.

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 NCT06962280
Study groupRoleWhat they receive
TirzepatideExperimentalParticipants will receive tirzepatide subcutaneously (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 (14)

  1. Change from Baseline in HbA1c

    Measured: Baseline, Week 72

  2. 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, Within 30 days prior to Week 72

  3. Change from Baseline in Body Weight

    Measured: Baseline, Week 40, Week 72

  4. Percent Change from Baseline in Body Weight

    Measured: Baseline, Week 40, Week 72

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

    Measured: Baseline, Week 40, Week 72

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

    Measured: Baseline, Week 40, Week 72

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

    Measured: Baseline, Week 40, Week 72

  8. Change from Baseline in Waist Circumference

    Measured: Baseline, Week 40, Week 72

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

    Measured: Baseline, Week 40, Week 72

  10. Percent Change from Baseline in Fasting Triglycerides

    Measured: Baseline, Week 40, Week 72

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

    Measured: Baseline, Week 40, Week 72

  12. Percent Change from Baseline in Total Daily Insulin Dose

    Measured: Baseline, Week 40, Week 72

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

    Measured: Baseline, Week 40, Week 72

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

    Measured: Baseline, Week 40, Week 72

Timeline

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

  1. First posted8 May 2025
  2. Study start12 May 2025
  3. Primary completionNov 2026 (estimated)
  4. Study completionJul 2027 (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
465 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06962280
Sponsor's protocol ID
27340
Other IDs
I8F-MC-GPJD, 2024-519685-51-00
Acronym
SURPASS-T1D-2
Status last verified
Feb 2026
First submitted
6 May 2025
Last updated
17 Feb 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 79 sites in 10 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 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in United States, Mexico, Argentina, Brazil, France and 5 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 NCT06962280.

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 17 Feb 2026.

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