Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPJA | Other Identifier | Eli Lilly and Company | |
| 2024-519684-17-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirzepatide Dose 1 | Experimental | Participants will receive tirzepatide subcutaneously (SC) |
|
| Tirzepatide Dose 2 | Experimental | Participants will receive tirzepatide SC |
|
| Tirzepatide Dose 3 | Experimental | Participants will receive tirzepatide SC |
|
| Tirzepatide Dose 4 | Experimental | Participants will receive tirzepatide SC |
|
| Placebo | Placebo Comparator | Participants will receive placebo SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 40 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sansum Diabetes Research Institute | Santa Barbara | California | 93105 | United States | ||
| Care Access - Santa Clarita |
Not provided
| Label | URL |
|---|---|
| A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight (SURPASS-T1D-1) | View source |
Not provided
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.
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.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Administered SC |
|
| 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 |
| Santa Clarita |
| California |
| 91321 |
| United States |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| 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 |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | United States |
| Rocky Mountain Clinical Research | Idaho Falls | Idaho | 83404 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | United States |
| Indiana University Health University Hospital | Indianapolis | Indiana | 46202 | United States |
| Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa | 50266 | United States |
| Endocrine and Metabolic Consultants | Rockville | Maryland | 20852 | United States |
| HealthPartners Institute dba International Diabetes Center | Minneapolis | Minnesota | 55416 | United States |
| SKY Integrative Medical Center/SKYCRNG | Ridgeland | Mississippi | 39157 | United States |
| Boeson Research MSO | Missoula | Montana | 59804 | United States |
| Palm Research Center Tenaya | Las Vegas | Nevada | 89128 | United States |
| Palm Research Center Sunset | Las Vegas | Nevada | 89148 | United States |
| 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 |
| Lucas Research, Inc. | Morehead City | North Carolina | 28557 | United States |
| Care Access - Lima | Lima | Ohio | 45805 | United States |
| Alliance for Multispecialty Research, LLC | Norman | Oklahoma | 73069 | United States |
| Suburban Research Associates | West Chester | Pennsylvania | 19380 | United States |
| 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 |
| Eastside Research Associates | Redmond | Washington | 98052 | United States |
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
| 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 |
| Advanced Clinical Research, LLC | Bayamón | 00959 | Puerto Rico |
| Manati Center for Clinical Research | Manati | 00674 | Puerto Rico |
| 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 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
Not provided
Not provided