Clinical trial NCT06914895: A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Type 1 Diabetes
Obesity
Overweight
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-04-06
Enrollment: 905
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 40
Secondary outcomes:
measure: 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
timeFrame: Within 30 days prior to Week 40
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Week 40
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 40
measure: Percentage of Participants with ≥5% Body Weight Reduction
timeFrame: Baseline, Week 40
measure: Percentage of Participants with ≥10% Body Weight Reduction
timeFrame: Baseline, Week 40
measure: Percentage of Participants with ≥15% Body Weight Reduction
timeFrame: Baseline, Week 40
measure: Change from Baseline in Waist Circumference
timeFrame: Baseline, Week 40
measure: Change from Baseline in Systolic Blood Pressure (SBP)
timeFrame: Baseline, Week 40
measure: Percent Change from Baseline in Fasting Triglycerides
timeFrame: Baseline, Week 40
measure: Percent Change from Baseline in Fasting Non-High-Density Lipoprotein (non-HDL) Cholesterol
timeFrame: Baseline, Week 40
measure: Percent Change from Baseline in Total Daily Insulin Dose
timeFrame: Baseline, Week 40
measure: Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
timeFrame: Baseline, Week 40
measure: Change from Baseline in EQ-5D-5L
timeFrame: Baseline, Week 40
Other outcomes:
Locations:
city: Goleta
country: United States
facility: Sansum Diabetes Research Institute
state: California
city: Santa Clarita
country: United States
facility: Care Access - Santa Clarita
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Decatur
country: United States
facility: Orita Clinical Research
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Covington
country: United States
facility: Saint Elizabeth Healthcare - Saint Elizabeth Covington Hospital
state: Kentucky
city: Rockville
country: United States
facility: Endocrine and Metabolic Consultants
state: Maryland
city: Minneapolis
country: United States
facility: HealthPartners Institute dba International Diabetes Center
state: Minnesota
city: Ridgeland
country: United States
facility: SKY Integrative Medical Center/SKYCRNG
state: Mississippi
city: Missoula
country: United States
facility: Boeson Research MSO
state: Montana
city: Las Vegas
country: United States
facility: Palm Research Center Tenaya
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center Sunset
state: Nevada
city: Albany
country: United States
facility: Albany Medical College, Division of Community Endocrinology
state: New York
city: Buffalo
country: United States
facility: Research Foundation of SUNY - University of Buffalo
state: New York
city: New York
country: United States
facility: NYC Research
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Morehead City
country: United States
facility: Lucas Research, Inc.
state: North Carolina
city: Lima
country: United States
facility: Care Access - Lima
state: Ohio
city: Norman
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Oklahoma
city: West Chester
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas
state: Texas
city: McKinney
country: United States
facility: Tekton Research, LLC.
state: Texas
city: Wylie
country: United States
facility: Medrasa Clinical Research
state: Texas
city: Redmond
country: United States
facility: Eastside Research Associates
state: Washington
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Mar del Plata
country: Argentina
facility: Centro de Investigaciones Médicas Mar del Plata
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Investigaciones Medicas Imoba Srl
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: CIPREC
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Consultorio de Investigación Clínica EMO SRL
state: Ciudad Autónoma De Buenos Aires
city: Cordoba
country: Argentina
facility: Centro Medico Privado San Vicente Diabetes
state: Córdoba
city: Río Cuarto
country: Argentina
facility: Instituto Médico Río Cuarto
state: Córdoba
city: Santa Rosa
country: Argentina
facility: Centro de Salud e Investigaciones Médicas
state: La Pampa
city: Rosario
country: Argentina
facility: Fundacion Estudios Clinicos
state: Santa Fe
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: CENUDIAB
city: Córdoba
country: Argentina
facility: Instituto de Investigaciones Clínicas Córdoba
city: Santa Fe
country: Argentina
facility: Centro de Diagnóstico y Rehabilitación (CEDIR)
city: Fortaleza
country: Brazil
facility: Centro De Diabetes Metabolismo E Endocrinologia
state: Ceará
city: Fortaleza
country: Brazil
facility: Private Practice - Dr.Miguel N. Hissa
state: Ceará
city: Vitória
country: Brazil
facility: CEDOES
state: Espírito Santo
city: Goiania
country: Brazil
facility: Universidade Federal de Goias
state: Goiás
city: Curitiba
country: Brazil
facility: Centro de Diabetes Curitiba
state: Paraná
city: Sao Paulo
country: Brazil
facility: CPCLIN
state: São Paulo
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clínica
city: São Paulo
country: Brazil
facility: IBTED - Tecnologia e Educação em Diabetes
city: São Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica
city: São Paulo
country: Brazil
facility: Hospital das Clinicas FMUSP
city: Herlev
country: Denmark
facility: Steno Diabetes Center - Copenhagen
state: Hovedstaden
city: Hillerod
country: Denmark
facility: Nordsjællands Hospital - Hillerød
state: Hovedstaden
city: Herning
country: Denmark
facility: Regionshospitalet Gødstrup
state: Midtjylland
city: Køge
country: Denmark
facility: Sjællands Universitetshospital Køge
state: Sjælland
city: Esbjerg
country: Denmark
facility: Sydvestjyst Sygehus
state: Syddanmark
city: Strasbourg
country: France
facility: CHU Strasbourg-Hautepierre
state: Alsace
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
state: Basse-Normandie
city: Marseille
country: France
facility: Hôpital Européen Marseille
state: Bouches-du-Rhône
city: Marseille
country: France
facility: Hôpital de la Conception
state: Bouches-du-Rhône
city: Le Creusot
country: France
facility: Hôtel-Dieu du Creusot - site Harfleur
state: Bourgogne
city: Toulouse cedex 9
country: France
facility: CHU Rangueil
state: Haute-Garonne
city: Montpellier
country: France
facility: CHU Montpellier Lapeyronie Hospital
state: Hérault
city: Nantes Cedex 1
country: France
facility: Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes
state: Loire-Atlantique
city: Toulon
country: France
facility: Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
state: Provence-Alpes-Côte-d'Azur
city: Lyon
country: France
facility: Centre du diabète DIAB-eCARE
state: Rhône-Alpes
city: Vénissieux
country: France
facility: Groupe Hospitalier Mutualiste Les Portes du Sud
state: Rhône-Alpes
city: Pontoise
country: France
facility: Hôpital NOVO
state: Val-d'Oise
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
state: Île-de-France
city: Bad Mergentheim
country: Germany
facility: Diabetespraxis Mergentheim
state: Baden-Württemberg
city: Karlsburg
country: Germany
facility: Klinikum Karlsburg
state: Mecklenburg-Vorpommern
city: Bochum
country: Germany
facility: Diabetes- und Stoffwechselpraxis Bochum
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: InnoDiab Forschung Gmbh
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Institut für Diabetesforschung GmbH Münster
state: Nordrhein-Westfalen
city: Ludwigshafen am Rhein
country: Germany
facility: Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz
state: Rheinland-Pfalz
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
state: Sachsen
city: Pirna
country: Germany
facility: Arztpraxis Christine Kosch Pirna
state: Sachsen
city: Oldenburg
country: Germany
facility: RED-Institut GmbH
state: Schleswig-Holstein
city: Hamburg
country: Germany
facility: Diabetes Zentrum Wilhelmsburg
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
state: HaDarom
city: Beer Yaacov
country: Israel
facility: Yitzhak Shamir Medical Center
state: HaMerkaz
city: Herzliya
country: Israel
facility: Institute of Diabetes, Technology and Research - Clalit Health
state: HaMerkaz
city: Petah-Tikva
country: Israel
facility: Schneider Children's Medical Center
state: HaMerkaz
city: Petah-Tikva
country: Israel
facility: Rabin Medical Center
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: HaMerkaz
city: Tel Aviv
country: Israel
facility: Diabetes Medical Center
state: Tell Abīb
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
state: Tell Abīb
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
state: Yerushalayim
city: Haifa
country: Israel
facility: Rambam Health Care Campus
state: Ḥeifā
city: Napoli
country: Italy
facility: University of Naples Federico II
state: Campania
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
state: Piemonte
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: Toscana
city: Padova
country: Italy
facility: Azienda Ospedale - Università Padova
state: Veneto
city: Bologna
country: Italy
facility: IRCCS - AOU di Bologna
city: Catanzaro
country: Italy
facility: AOU Renato Dulbecco
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
city: Kasugai
country: Japan
facility: Kasugai Municipal Hospital
state: Aichi
city: Nagoya-shi
country: Japan
facility: Tosaki Clinic for Diabetes and Endocrinology
state: Aichi
city: Nagoya
country: Japan
facility: Soleil Chikusa Clinic
state: Aichi
city: Kisarazu
country: Japan
facility: Kimitsu Chuo Hospital
state: Chiba
city: Matsuyama
country: Japan
facility: Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
state: Ehime
city: Kure
country: Japan
facility: Kure Medical Center
state: Hiroshima
city: Sapporo
country: Japan
facility: Odori Diabetes
state: Hokkaido
city: Sapporo
country: Japan
facility: Manda Memorial Hospital
state: Hokkaido
city: Mito
country: Japan
facility: Kozawa Eye Hospital and Diabetes Center
state: Ibaraki
city: Naka
country: Japan
facility: Nakakinen clinic
state: Ibaraki
city: Ushiku
country: Japan
facility: Noritake Clinic
state: Ibaraki
city: Ebina
country: Japan
facility: Matoba Internal Medicine Clinic
state: Kanagawa
city: Kamakura-shi
country: Japan
facility: Takai Internal Medicine Clinic
state: Kanagawa
city: Kashiwara
country: Japan
facility: Shiraiwa Medical Clinic
state: Osaka
city: Shizuoka-city
country: Japan
facility: Suruga Clinic
state: Shizuoka
city: Chuo-ku
country: Japan
facility: The Institute of Medical Science, Asahi Life Foundation
state: Tokyo
city: Hachioji-shi
country: Japan
facility: Hachioji Diabetes Clinic
state: Tokyo
city: Shinjuku
country: Japan
facility: Tomonaga Clinic
state: Tokyo
city: Tama
country: Japan
facility: Tama Center Clinic Mirai
state: Tokyo
city: Shimonoseki
country: Japan
facility: Shimonoseki Medical Center
state: Yamaguchi
city: Kofu
country: Japan
facility: Yamanashi Prefectural Central Hospital
state: Yamanashi
city: Fukuoka
country: Japan
facility: Clinic Masae Minami
city: Fukuoka
country: Japan
facility: Japanese Red Cross Fukuoka Hospital
city: Kumamoto
country: Japan
facility: Kumamoto Central Hospital - Kumamoto
city: Kumamoto
country: Japan
facility: Jinnouchi Hospital
city: Miyazaki
country: Japan
facility: Heiwadai Hospital
city: Oita
country: Japan
facility: Abe Clinic
city: Osaka
country: Japan
facility: Osaka City General Hospital
city: Wakayama
country: Japan
facility: Japanese Red Cross Society - Wakayama Medical Center
city: Guadalajara
country: Mexico
facility: Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente
state: Jalisco
city: Guadalajara
country: Mexico
facility: Centro de Investigacion Medica de Occidente, S.C.
state: Jalisco
city: Guadalajara
country: Mexico
facility: Unidad de Investigación Clínica y Atención Médica HEPA S.C.
state: Jalisco
city: Hacienda De Las Palmas
country: Mexico
facility: Invecordis S.C.
state: México
city: Monterrey
country: Mexico
facility: CEINV Salud
state: Nuevo León
city: Monterrey
country: Mexico
facility: Clínica García Flores SC
state: Nuevo León
city: Tampico
country: Mexico
facility: Medsal Centro Médico
state: Tamaulipas
city: Chihuahua
country: Mexico
facility: Enclifar Ensayos Clínicos Farmacológicos Sc
city: Puebla
country: Mexico
facility: Consultorio Médico de Endocrinología y Pediatría
city: Bayamón
country: Puerto Rico
facility: Advanced Clinical Research, LLC
city: Manati
country: Puerto Rico
facility: Manati Center for Clinical Research
city: A Coruña
country: Spain
facility: CHUAC-Complejo Hospitalario Universitario A Coruña
state: A Coruña [La Coruña]
city: Ferrol
country: Spain
facility: Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
state: A Coruña [La Coruña]
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
state: Catalunya [Cataluña]
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalunya [Cataluña]
city: Móstoles
country: Spain
facility: Hospital Universitario de Móstoles
state: Madrid
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: