Clinical trial NCT06962280: A Long-Term Study of Tirzepatide (LY3298176) 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 Long-Term Safety of Tirzepatide Once Weekly Compared to Placebo in Adults 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: 2025-05-08
Enrollment: 465
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 long-term in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 20 months.


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: Change from Baseline in HbA1c
timeFrame: Baseline, Week 72
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, Within 30 days prior to Week 72
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Week 40, Week 72
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 40, Week 72
measure: Percentage of Participants with ≥5% Body Weight Reduction
timeFrame: Baseline, Week 40, Week 72
measure: Percentage of Participants with ≥10% Body Weight Reduction
timeFrame: Baseline, Week 40, Week 72
measure: Percentage of Participants with ≥15% Body Weight Reduction
timeFrame: Baseline, Week 40, Week 72
measure: Change from Baseline in Waist Circumference
timeFrame: Baseline, Week 40, Week 72
measure: Change from Baseline in Systolic Blood Pressure (SBP)
timeFrame: Baseline, Week 40, Week 72
measure: Percent Change from Baseline in Fasting Triglycerides
timeFrame: Baseline, Week 40, Week 72
measure: Percent Change from Baseline in Fasting Non-High-Density Lipoprotein (non-HDL) Cholesterol
timeFrame: Baseline, Week 40, Week 72
measure: Percent Change from Baseline in Total Daily Insulin Dose
timeFrame: Baseline, Week 40, Week 72
measure: Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
timeFrame: Baseline, Week 40, Week 72
measure: Change from Baseline in EQ-5D-5L
timeFrame: Baseline, Week 40, Week 72
Other outcomes:
Locations:
city: Bonita
country: United States
facility: Kaiser Permanente Bonita Medical Offices
state: California
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Newport Beach
country: United States
facility: Mary & Dick Allen Diabetes Center
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Minneapolis
country: United States
facility: HealthPartners Institute dba International Diabetes Center
state: Minnesota
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Springfield
country: United States
facility: Clinvest Headlands Llc
state: Missouri
city: Henderson
country: United States
facility: Las Vegas Endocrinology
state: Nevada
city: Chapel Hill
country: United States
facility: University of North Carolina Medical Center
state: North Carolina
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas
state: Texas
city: Houston
country: United States
facility: Juno Research
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: San Antonio
country: United States
facility: San Antonio Clinical Trials
state: Texas
city: Weslaco
country: United States
facility: Texas Valley Clinical Research
state: Texas
city: Buenos Aires
country: Argentina
facility: Stat Research S.A.
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Mautalen Salud e Investigación
state: Ciudad Autónoma De Buenos Aires
city: Godoy Cruz
country: Argentina
facility: CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
state: Mendoza
city: Granadero Baigorria
country: Argentina
facility: Centro de Investigaciones Clínicas Baigorria
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto Médico Catamarca IMEC
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Investigaciones Clínicas Tucumán
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Buenos Aires Macula S.A
city: Córdoba
country: Argentina
facility: Centro Diabetológico Dr. Waitman
city: Fortaleza
country: Brazil
facility: Instituto de Estudos e Pesquisas Clinicas do Ceara IEP-CE
state: Ceará
city: Brasilia
country: Brazil
facility: Centro de Pesquisa Clinica do Brasil
state: Distrito Federal
city: Goiânia
country: Brazil
facility: Cendi - Endocrinologia e Diabetes
state: Goiás
city: Curitiba
country: Brazil
facility: Quanta Diagnóstico e Terapia
state: Paraná
city: Porto Alegre
country: Brazil
facility: Instituto da Crianca com Diabetes
state: Rio Grande Do Sul
city: Campinas
country: Brazil
facility: Centro de Pesquisa Sao Lucas
state: São Paulo
city: Sao Paulo
country: Brazil
facility: CPCLIN
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: IBPClin - Instituto Brasil de Pesquisa Clínica
city: São Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica
city: Calgary
country: Canada
facility: C-health Research
state: Alberta
city: Surrey
country: Canada
facility: TLC Diabetes and Endocrinology
state: British Columbia
city: Sydney
country: Canada
facility: Care Access - Cape Breton
state: Nova Scotia
city: Ottawa
country: Canada
facility: Centricity Research Ottawa LMC Endocrinology
state: Ontario
city: Montréal
country: Canada
facility: Endocrinologie Oasis
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre de Recherche Saint-Louis
state: Quebec
city: Chrudim III
country: Czechia
facility: INTENDIA klinika s.r.o.
state: Chrudim
city: Krnov
country: Czechia
facility: MUDr. Tomas Edelsberger
state: Moravskoslezský Kraj
city: Hranice
country: Czechia
facility: AIDIN VK s.r.o.
state: Olomoucký Kraj
city: Praha
country: Czechia
facility: Milan Kvapil s.r.o., Diabetologicka ambulance
state: Praha 4
city: Praha
country: Czechia
facility: ResTrial s.r.o.
state: Praha 8
city: Olomouc
country: Czechia
facility: Diabetologicke centrum s.r.o.
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: Bois-Guillaume
country: France
facility: Centre Hospitalier Universitaire - Hôpitaux de Rouen - Hôpital de Bois-Guillaume
state: Haute-Normandie
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire de Grenoble
state: Isère
city: Vénissieux
country: France
facility: Groupe Hospitalier Mutualiste Les Portes du Sud
state: Rhône-Alpes
city: Paris
country: France
facility: Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
state: Île-de-France
city: Paleo Faliro
country: Greece
facility: Iatriko Paleou Falirou Medical Center
state: Attikí (Region)
city: Athens
country: Greece
facility: Athens Medical Center
state: Attikí
city: Thessaloniki
country: Greece
facility: Ippokrateio General Hospital of Thessaloniki
state: Kentrikí Makedonía
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic of Thessaloniki
state: Thessaloníki
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente
state: Jalisco
city: Guadalajara
country: Mexico
facility: Private Practice - Dr. Arechavaleta Granell Maria del Rosario
state: Jalisco
city: Guadalajara
country: Mexico
facility: Unidad de Investigación Clínica y Atención Médica HEPA S.C.
state: Jalisco
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: Brasov
country: Romania
facility: Mariodiab Clinic
state: Brașov
city: Bucharest
country: Romania
facility: Sanamed Hospital
state: București
city: Targoviste
country: Romania
facility: Rinart Diab SRL
state: Dâmbovița
city: Bucharest
country: Romania
facility: Centrul medical DiabNutriMed
state: Ilfov
city: Baia Mare
country: Romania
facility: CMI DNBM Dr. Pop Lavinia
state: Maramureș
city: București
country: Romania
facility: Diabet Med
city: Galați
country: Romania
facility: Diamed Obesity
city: Iași
country: Romania
facility: Centrul Medical Consultmed
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
state: Catalunya [Cataluña]
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
state: Madrid, Comunidad De
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
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: