Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT06914895 (SURPASS-T1D-1) for Type 1 Diabetes, Obesity, Overweight is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Back to Search
Eli Lilly and CompanyA Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight (SURPASS-T1D-1) Phase 3 905
Clinical Trial NCT06914895 (SURPASS-T1D-1) is designed to study Treatment for Type 1 Diabetes, Obesity, Overweight. It is a Phase 3 interventional study that is active, not recruiting, having started on April 25, 2025, with plans to enroll 905 participants. Led by Eli Lilly and Company, it is expected to complete by December 1, 2026. The latest data from ClinicalTrials.gov was last updated on February 17, 2026.
Brief 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.
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
Conditions
Type 1 DiabetesObesityOverweightOther Study IDs
- SURPASS-T1D-1
- 27285
- I8F-MC-GPJA (Other Identifier) (Eli Lilly and Company)
- 2024-519684-17-00 (EU Study (CTIS) Number)
NCT ID Number
Start Date (Actual)
2025-04-25
Last Update Posted
2026-02-17
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
905
Study Type
Interventional
PHASE
Phase 3
Status
Active, not recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalTirzepatide Dose 1 Participants will receive tirzepatide subcutaneously (SC) | Tirzepatide Administered SC |
ExperimentalTirzepatide Dose 2 Participants will receive tirzepatide SC | Tirzepatide Administered SC |
ExperimentalTirzepatide Dose 3 Participants will receive tirzepatide SC | Tirzepatide Administered SC |
ExperimentalTirzepatide Dose 4 Participants will receive tirzepatide SC | Tirzepatide Administered SC |
Placebo ComparatorPlacebo Participants will receive placebo SC | Placebo Administered SC |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 40 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | |
Change from Baseline in Body Weight | Baseline, Week 40 | |
Percent Change from Baseline in Body Weight | Baseline, Week 40 | |
Percentage of Participants with ≥5% Body Weight Reduction | Baseline, Week 40 | |
Percentage of Participants with ≥10% Body Weight Reduction | Baseline, Week 40 | |
Percentage of Participants with ≥15% Body Weight Reduction | Baseline, Week 40 | |
Change from Baseline in Waist Circumference | Baseline, Week 40 | |
Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 40 | |
Percent Change from Baseline in Fasting Triglycerides | Baseline, Week 40 | |
Percent Change from Baseline in Fasting Non-High-Density Lipoprotein (non-HDL) Cholesterol | Baseline, Week 40 | |
Percent Change from Baseline in Total Daily Insulin Dose | Baseline, Week 40 | |
Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) | Baseline, Week 40 | |
Change from Baseline in EQ-5D-5L | Baseline, Week 40 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
Eli Lilly and Company362 active studies to exploreNo contact data.
146 Study Locations in 12 Countries
California
Sansum Diabetes Research Institute, Santa Barbara, California, 93105, United States
Care Access - Santa Clarita, Santa Clarita, California, 91321, United States
Colorado
University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States
Georgia
Atlanta Diabetes Associates, Atlanta, Georgia, 30318, United States
Orita Clinical Research, Decatur, Georgia, 30034, United States
North Georgia Clinical Research, Woodstock, Georgia, 30189, United States
Hawaii
East-West Medical Research Institute, Honolulu, Hawaii, 96814, United States
Idaho
Rocky Mountain Clinical Research, Idaho Falls, Idaho, 83404, United States
Illinois
Southern Illinois University School of Medicine, Springfield, Illinois, 62702, United States
Indiana
Indiana University Health University Hospital, Indianapolis, Indiana, 46202, United States
Iowa
Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50266, United States
Maryland
Endocrine and Metabolic Consultants, Rockville, Maryland, 20852, United States
Minnesota
HealthPartners Institute dba International Diabetes Center, Minneapolis, Minnesota, 55416, United States
Mississippi
SKY Integrative Medical Center/SKYCRNG, Ridgeland, Mississippi, 39157, United States
Montana
Boeson Research MSO, Missoula, Montana, 59804, United States
Nevada
Palm Research Center Tenaya, Las Vegas, Nevada, 89128, United States
Palm Research Center Sunset, Las Vegas, Nevada, 89148, United States
New York
Albany Medical College, Division of Community Endocrinology, Albany, New York, 12203, United States
Research Foundation of SUNY - University of Buffalo, Buffalo, New York, 14221, United States
NYC Research, New York, New York, 10016, United States
SUNY Upstate Medical University, Syracuse, New York, 13210, United States
North Carolina
Lucas Research, Inc., Morehead City, North Carolina, 28557, United States
Ohio
Care Access - Lima, Lima, Ohio, 45805, United States
Oklahoma
Alliance for Multispecialty Research, LLC, Norman, Oklahoma, 73069, United States
Pennsylvania
Suburban Research Associates, West Chester, Pennsylvania, 19380, United States
Texas
Texas Diabetes & Endocrinology, P.A., Austin, Texas, 78731, United States
Velocity Clinical Research, Dallas, Dallas, Texas, 75230, United States
Tekton Research, LLC., McKinney, Texas, 75069, United States
Medrasa Clinical Research, Wylie, Texas, 75098, United States
Washington
Eastside Research Associates, Redmond, Washington, 98052, United States
Rainier Clinical Research Center, Renton, Washington, 98057, United States
Advanced Clinical Research, LLC, Bayamón, 00959, Puerto Rico
Manati Center for Clinical Research, Manatí, 00674, Puerto Rico
Investigaciones Medicas Imoba Srl, Buenos Aires, C1056ABH, Argentina
Centro de Investigaciones Metabólicas (CINME), Buenos Aires, C1056ABI, Argentina
CIPREC, Buenos Aires, C1119ACN, Argentina
Consultorio de Investigación Clínica EMO SRL, Buenos Aires, C1405BUB, Argentina
CENUDIAB, Buenos Aires, C1440AAD, Argentina
Instituto de Investigaciones Clínicas Córdoba, Córdoba, 5000, Argentina
Centro Medico Privado San Vicente Diabetes, Córdoba, 5006, Argentina
Centro de Investigaciones Médicas Mar del Plata, Mar del Plata, 7600, Argentina
Instituto Médico Río Cuarto, Río Cuarto, X5800AEV, Argentina
Fundacion Estudios Clinicos, Rosario, 2000, Argentina
Centro de Diagnóstico y Rehabilitación (CEDIR), Santa Fe, 3000, Argentina
Centro de Salud e Investigaciones Médicas, Santa Rosa, L6300, Argentina
Centro de Diabetes Curitiba, Curitiba, 80810-040, Brazil
Centro De Diabetes Metabolismo E Endocrinologia, Fortaleza, 60175-047, Brazil
Private Practice - Dr.Miguel N. Hissa, Fortaleza, 60430-350, Brazil
Universidade Federal de Goias, Goiânia, 74605-020, Brazil
CPQuali Pesquisa Clínica, São Paulo, 01228-000, Brazil
CPCLIN, São Paulo, 01228-200, Brazil
IBTED - Tecnologia e Educação em Diabetes, São Paulo, 04038-032, Brazil
CEPIC - Centro Paulista de Investigação Clínica, São Paulo, 04266-010, Brazil
Hospital das Clinicas FMUSP, São Paulo, 05403-000, Brazil
CEDOES, Vitória, 29055450, Brazil
Esbjerg sygehus, Syddansk Universitetshospital, Esbjerg, 6700, Denmark
Steno Diabetes Center - Copenhagen, Herlev, 2730, Denmark
Regionshospitalet Gødstrup, Herning, 7400, Denmark
Nordsjællands Hospital - Hillerød, Hillerød, 3400, Denmark
Sjællands Universitetshospital Køge, Køge, 4600, Denmark
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre, Caen, 14033, France
Centre Hospitalier Sud Francilien, Corbeil-Essonnes, 91106, France
Hôtel-Dieu du Creusot - site Harfleur, Le Creusot, 71200, France
Centre du diabète DIAB-eCARE, Lyon, 69008, France
Hôpital Européen Marseille, Marseille, 13003, France
Hôpital de la Conception, Marseille, 13005, France
CHU Montpellier Lapeyronie Hospital, Montpellier, 34295, France
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes, Nantes, 44093, France
Hôpital NOVO, Pontoise, 95300, France
CHU Strasbourg-Hautepierre, Strasbourg, 67098, France
Centre Hospitalier intercommunal de Toulon La Seyne sur Mer, Toulon, 83100, France
CHU Rangueil, Toulouse, 31059, France
Groupe Hospitalier Mutualiste Les Portes du Sud, Vénissieux, 69200, France
Diabetespraxis Mergentheim, Bad Mergentheim, 97980, Germany
Diabetes- und Stoffwechselpraxis Bochum, Bochum, 44869, Germany
InnoDiab Forschung Gmbh, Essen, 45136, Germany
Diabetes Zentrum Wilhelmsburg, Hamburg, 21109, Germany
Klinikum Karlsburg, Karlsburg, 17495, Germany
Universitätsklinikum Leipzig, Leipzig, 04103, Germany
Institut für Diabetesforschung GmbH Münster, Münster, 48145, Germany
RED-Institut GmbH, Oldenburg, 23758, Germany
Arztpraxis Christine Kosch Pirna, Pirna, 01796, Germany
Yitzhak Shamir Medical Center, Beer Yaacov, 70300, Israel
Soroka Medical Center, Beersheba, 8410101, Israel
Rambam Health Care Campus, Haifa, 3109601, Israel
Institute of Diabetes, Technology and Research - Clalit Health, Herzliya, 4600201, Israel
Hadassah Medical Center, Jerusalem, 9112001, Israel
Schneider Children's Medical Center, Petah Tikva, 4920235, Israel
Rabin Medical Center, Petah Tikva, 4941492, Israel
Sheba Medical Center, Ramat Gan, 5262100, Israel
Diabetes Medical Center, Tel Aviv, 51549, Israel
Sourasky Medical Center, Tel Aviv, 6423906, Israel
IRCCS - AOU di Bologna, Bologna, 40138, Italy
AOU Renato Dulbecco, Catanzaro, 88100, Italy
Azienda Ospedaliera Universitaria Careggi, Florence, 50134, Italy
Ospedale San Raffaele, Milan, 20132, Italy
University of Naples Federico II, Naples, 80100, Italy
Azienda Ospedale - Università Padova, Padova, 35128, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore, Roma, 00168, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, 10126, Italy
The Institute of Medical Science, Asahi Life Foundation, Chūōku, 103-0002, Japan
Matoba Internal Medicine Clinic, Ebina, 243-0432, Japan
Clinic Masae Minami, Fukuoka, 815-0071, Japan
Japanese Red Cross Fukuoka Hospital, Fukuoka, 815-8555, Japan
Hachioji Diabetes Clinic, Hachioji-shi, 192-0083, Japan
Takai Internal Medicine Clinic, Kamakura-shi, 247-0056, Japan
Shiraiwa Medical Clinic, Kashiwara, 582-0005, Japan
Kasugai Municipal Hospital, Kasugai, 486-8510, Japan
Kimitsu Chuo Hospital, Kisarazu, 292-8535, Japan
Yamanashi Prefectural Central Hospital, Kofu, 400-8506, Japan
Kumamoto Central Hospital - Kumamoto, Kumamoto, 862-0965, Japan
Jinnouchi Hospital, Kumamoto, 862-0976, Japan
Kure Medical Center, Kure, 737-0023, Japan
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism, Matsuyama, 790-0034, Japan
Kozawa Eye Hospital and Diabetes Center, Mito, 310-0845, Japan
Heiwadai Hospital, Miyazaki, 880-0034, Japan
Soleil Chikusa Clinic, Nagoya, 464-0858, Japan
Tosaki Clinic for Diabetes and Endocrinology, Nagoya, 468-0009, Japan
Nakakinen clinic, Naka, 311-0113, Japan
Osaka City General Hospital, Osaka, 534-0021, Japan
Abe Clinic, Ōita, 870-0039, Japan
Odori Diabetes, Sapporo, 060-0001, Japan
Manda Memorial Hospital, Sapporo, 060-0062, Japan
Shimonoseki Medical Center, Shimonoseki, 750-0061, Japan
Tomonaga Clinic, Shinjuku, 160-0022, Japan
Suruga Clinic, Shizuoka, 424-0855, Japan
Tama Center Clinic Mirai, Tama, 206-0033, Japan
Noritake Clinic, Ushiku, 300-1207, Japan
Japanese Red Cross Society - Wakayama Medical Center, Wakayama, 640-8558, Japan
Enclifar Ensayos Clínicos Farmacológicos Sc, Chihuahua City, 31110, Mexico
Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente, Guadalajara, 44150, Mexico
Centro de Investigacion Medica de Occidente, S.C., Guadalajara, 44260, Mexico
Unidad de Investigación Clínica y Atención Médica HEPA S.C., Guadalajara, 44670, Mexico
Invecordis S.C., Hacienda de Las Palmas, 52763, 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
CHUAC-Complejo Hospitalario Universitario A Coruña, A Coruña, 15006, Spain
Hospital Universitari Vall d'Hebron, Barcelona, 08035, Spain
Hospital Clínic de Barcelona, Barcelona, 08036, Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, 08041, Spain
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval, Ferrol, 15405, Spain
Hospital Universitario de Móstoles, Móstoles, 28935, Spain
Hospital Universitario Marqués de Valdecilla, Santander, 39008, Spain
Hospital Universitario Virgen Del Rocio, Seville, 41013, Spain