A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight
SURPASS-T1D-2
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
3 other identifiers
interventional
465
10 countries
79
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2025
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2025
CompletedFirst Posted
Study publicly available on registry
May 8, 2025
CompletedStudy Start
First participant enrolled
May 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
February 17, 2026
February 1, 2026
1.5 years
May 6, 2025
February 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Hemoglobin A1c (HbA1c)
Baseline, Week 40
Secondary Outcomes (14)
Change from Baseline in HbA1c
Baseline, Week 72
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
Within 30 days prior to Week 40, Within 30 days prior to Week 72
Change from Baseline in Body Weight
Baseline, Week 40, Week 72
Percent Change from Baseline in Body Weight
Baseline, Week 40, Week 72
Percentage of Participants with ≥5% Body Weight Reduction
Baseline, Week 40, Week 72
- +9 more secondary outcomes
Study Arms (2)
Tirzepatide
EXPERIMENTALParticipants will receive tirzepatide subcutaneously (SC)
Placebo
PLACEBO COMPARATORParticipants will receive placebo SC
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (79)
Kaiser Permanente Bonita Medical Offices
Bonita, California, 91902, United States
AMCR Institute
Escondido, California, 92025, United States
Mary & Dick Allen Diabetes Center
Newport Beach, California, 92663, United States
University Clinical Investigators, Inc.
Tustin, California, 92780, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50266, United States
HealthPartners Institute dba International Diabetes Center
Minneapolis, Minnesota, 55416, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
Clinvest Headlands Llc
Springfield, Missouri, 65807, United States
Las Vegas Endocrinology
Henderson, Nevada, 89074, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514, United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230, United States
Juno Research
Houston, Texas, 77040, United States
Southern Endocrinology Associates
Mesquite, Texas, 75149, United States
Texas Diabetes & Endocrinology, P.A.
Round Rock, Texas, 78681, United States
San Antonio Clinical Trials
San Antonio, Texas, 78240, United States
Texas Valley Clinical Research
Weslaco, Texas, 78596, United States
Buenos Aires Macula S.A
Buenos Aires, 1061, Argentina
Stat Research S.A.
Buenos Aires, C1023AAB, Argentina
Mautalen Salud e Investigación
Buenos Aires, C1128AAF, Argentina
Centro Diabetológico Dr. Waitman
Córdoba, 5000, Argentina
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
Godoy Cruz, M5501ARP, Argentina
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria, 2152, Argentina
Instituto Médico Catamarca IMEC
Rosario, 2000, Argentina
Investigaciones Clínicas Tucumán
San Miguel de Tucumán, T4000ICL, Argentina
Centro de Pesquisa Clinica do Brasil
Brasília, 71625-175, Brazil
Centro de Pesquisa Sao Lucas
Campinas, 13060-803, Brazil
Quanta Diagnóstico e Terapia
Curitiba, 80045170, Brazil
Cendi - Endocrinologia e Diabetes
Goiânia, 74230-035, Brazil
Instituto da Crianca com Diabetes
Porto Alegre, 91350-250, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, 20241-180, Brazil
CPCLIN
São Paulo, 01228-200, Brazil
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010, Brazil
Endocrinologie Oasis
Montreal, H4J 1E3, Canada
Centricity Research Ottawa LMC Endocrinology
Ottawa, K2J 0V2, Canada
Centre de Recherche Saint-Louis
Sherbrooke, J1G 1X9, Canada
TLC Diabetes and Endocrinology
Surrey, V3T 2V6, Canada
Care Access - Cape Breton
Sydney, B1M 0A1, Canada
INTENDIA klinika s.r.o.
Chrudim III, 537 01, Czechia
AIDIN VK s.r.o.
Hranice, 753 01, Czechia
MUDr. Tomas Edelsberger
Krnov, 79401, Czechia
Diabetologicke centrum s.r.o.
Olomouc, 779 00, Czechia
Milan Kvapil s.r.o., Diabetologicka ambulance
Prague, 14900, Czechia
ResTrial s.r.o.
Prague, 18100, Czechia
Centre Hospitalier Universitaire - Hôpitaux de Rouen - Hôpital de Bois-Guillaume
Bois-Guillaume, 76230, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91106, France
Centre Hospitalier Universitaire de Grenoble
Grenoble, 38700, France
Hôtel-Dieu du Creusot - site Harfleur
Le Creusot, 71200, France
Hôpital de la Conception
Marseille, 13005, France
Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière
Paris, 75010, France
CHU Rangueil
Toulouse, 31059, France
Groupe Hospitalier Mutualiste Les Portes du Sud
Vénissieux, 69200, France
Athens Medical Center
Athens, 151 25, Greece
Iatriko Paleou Falirou Medical Center
Palaió Fáliro, 17562, Greece
Euromedica General Clinic of Thessaloniki
Thessaloniki, 546 45, Greece
Ippokrateio General Hospital of Thessaloniki
Thessaloniki, 54642, Greece
Enclifar Ensayos Clínicos Farmacológicos Sc
Chihuahua City, 31110, Mexico
Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente
Guadalajara, 44150, Mexico
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
Guadalajara, 44670, Mexico
Unidad de Investigación Clínica y Atención Médica HEPA S.C.
Guadalajara, 44670, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080, Mexico
CEINV Salud
Monterrey, 64020, Mexico
Clínica García Flores SC
Monterrey, 64610, Mexico
Consultorio Médico de Endocrinología y Pediatría
Puebla City, 72190, Mexico
Medsal Centro Médico
Tampico, 89210, Mexico
CMI DNBM Dr. Pop Lavinia
Baia Mare, 430222, Romania
Mariodiab Clinic
Brasov, 500097, Romania
Centrul medical DiabNutriMed
Bucharest, 020359, Romania
Diabet Med
Bucharest, 050913, Romania
Sanamed Hospital
Bucharest, 060013, Romania
Diamed Obesity
Galați, 800291, Romania
Centrul Medical Consultmed
Iași, 700547, Romania
Rinart Diab SRL
Târgovişte, 130168, Romania
Hospital Infanta Cristina
Badajoz, 06080, Spain
Hospital Germans Trias i Pujol
Badalona, 08916, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2025
First Posted
May 8, 2025
Study Start
May 12, 2025
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
July 1, 2027
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.