A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight

Phase 3

Not yet recruiting

• Conditions: Type 1 Diabetes; Obesity; Overweight
• Interventions: Drug: Tirzepatide; Drug: Placebo

• Registration Number: NCT06962280
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05
• Study First Submitted: 2025-05-06
• Study First Submitted QC: 2025-05-06
• Study First Posted: 2025-05-08
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2027-04
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 465

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tirzepatide	Tirzepatide	Participants will receive tirzepatide subcutaneously (SC)
Placebo	Placebo	Participants will receive placebo SC

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Hemoglobin A1c (HbA1c)	Baseline, Week 40

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in HbA1c	Baseline, Week 72
Percentage of Participants with ≥5% Body Weight Reduction	Baseline, Week 40, Week 72
Percentage of Participants with ≥10% Body Weight Reduction	Baseline, Week 40, Week 72
Percentage of Participants with ≥15% Body Weight Reduction	Baseline, Week 40, Week 72
Change from Baseline in Waist Circumference	Baseline, Week 40, Week 72
Change from Baseline in Systolic Blood Pressure (SBP)	Baseline, Week 40, Week 72
Percent Change from Baseline in Fasting Triglycerides	Baseline, Week 40, Week 72
Percent Change from Baseline in Fasting Non-High-Density Lipoprotein (non-HDL) Cholesterol	Baseline, Week 40, Week 72
Percent Change from Baseline in Total Daily Insulin Dose	Baseline, Week 40, Week 72
Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)	Baseline, Week 40, Week 72
Change from Baseline in EQ-5D-5L	Baseline, Week 40, 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

Trial Locations

Locations (81)

Kaiser Permanente Bonita Medical Offices; 🇺🇸 Bonita, California, United States

AMCR Institute; 🇺🇸 Escondido, California, United States

Mary & Dick Allen Diabetes Center; 🇺🇸 Newport Beach, California, United States

University Clinical Investigators, Inc.; 🇺🇸 Tustin, California, United States

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

Metabolic Research Institute, Inc.; 🇺🇸 West Palm Beach, Florida, United States

Iowa Diabetes and Endocrinology Research Center; 🇺🇸 West Des Moines, Iowa, United States

HealthPartners Institute dba International Diabetes Center; 🇺🇸 Minneapolis, Minnesota, United States

Clinical Research Professionals; 🇺🇸 Chesterfield, Missouri, United States

Clinvest Headlands Llc; 🇺🇸 Springfield, Missouri, United States

Las Vegas Endocrinology; 🇺🇸 Henderson, Nevada, United States

University of North Carolina Medical Center; 🇺🇸 Chapel Hill, North Carolina, United States

Velocity Clinical Research, Dallas; 🇺🇸 Dallas, Texas, United States

Juno Research; 🇺🇸 Houston, Texas, United States

Southern Endocrinology Associates; 🇺🇸 Mesquite, Texas, United States

Texas Diabetes & Endocrinology, P.A.; 🇺🇸 Round Rock, Texas, United States

San Antonio Clinical Trials; 🇺🇸 San Antonio, Texas, United States

Texas Valley Clinical Research; 🇺🇸 Weslaco, Texas, United States

Stat Research S.A.; 🇦🇷 Buenos Aires, Ciudad Autónoma de Buenos Aires, Argentina

Mautalen Salud e Investigación; 🇦🇷 Buenos Aires, Ciudad Autónoma de Buenos Aires, Argentina

CIPADI - Centro Integral de Prevencion y Atencion en Diabetes; 🇦🇷 Godoy Cruz, Mendoza, Argentina

Centro de Investigaciones Clínicas Baigorria; 🇦🇷 Granadero Baigorria, Santa Fe, Argentina

Instituto Médico Catamarca IMEC; 🇦🇷 Rosario, Santa Fe, Argentina

Investigaciones Clínicas Tucumán; 🇦🇷 San Miguel de Tucuman, Tucumán, Argentina

Buenos Aires Macula S.A; 🇦🇷 Buenos Aires, Argentina

Centro Diabetológico Dr. Waitman; 🇦🇷 Córdoba, Argentina

Instituto de Estudos e Pesquisas Clinicas do Ceara IEP-CE; 🇧🇷 Fortaleza, Ceará, Brazil

Centro de Pesquisa Clinica do Brasil; 🇧🇷 Brasilia, Distrito Federal, Brazil

Cendi - Endocrinologia e Diabetes; 🇧🇷 Goiânia, Goiás, Brazil

Quanta Diagnóstico e Terapia; 🇧🇷 Curitiba, Paraná, Brazil

Instituto da Crianca com Diabetes; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil

Centro de Pesquisa Sao Lucas; 🇧🇷 Campinas, São Paulo, Brazil

CPCLIN; 🇧🇷 Sao Paulo, São Paulo, Brazil

IBPClin - Instituto Brasil de Pesquisa Clínica; 🇧🇷 Rio de Janeiro, Brazil

CEPIC - Centro Paulista de Investigação Clínica; 🇧🇷 São Paulo, Brazil

C-health Research; 🇨🇦 Calgary, Alberta, Canada

TLC Diabetes and Endocrinology; 🇨🇦 Surrey, British Columbia, Canada

Care Access - Cape Breton; 🇨🇦 Sydney, Nova Scotia, Canada

Centricity Research Ottawa LMC Endocrinology; 🇨🇦 Ottawa, Ontario, Canada

Endocrinologie Oasis; 🇨🇦 Montréal, Quebec, Canada

Centre de Recherche Saint-Louis; 🇨🇦 Sherbrooke, Quebec, Canada

INTENDIA klinika s.r.o.; 🇨🇿 Chrudim III, Chrudim, Czechia

MUDr. Tomas Edelsberger; 🇨🇿 Krnov, Moravskoslezský kraj, Czechia

AIDIN VK s.r.o.; 🇨🇿 Hranice, Olomoucký kraj, Czechia

Milan Kvapil s.r.o., Diabetologicka ambulance; 🇨🇿 Praha, Praha 4, Czechia

ResTrial s.r.o.; 🇨🇿 Praha, Praha 8, Czechia

Diabetologicke centrum s.r.o.; 🇨🇿 Olomouc, Czechia

Hôpital de la Conception; 🇫🇷 Marseille, Bouches-du-Rhône, France

Hôtel-Dieu du Creusot - site Harfleur; 🇫🇷 Le Creusot, Bourgogne, France

CHU Rangueil; 🇫🇷 Toulouse cedex 9, Haute-Garonne, France

Centre Hospitalier Universitaire - Hôpitaux de Rouen - Hôpital de Bois-Guillaume; 🇫🇷 Bois-Guillaume, Haute-Normandie, France

Centre Hospitalier Universitaire de Grenoble; 🇫🇷 Grenoble, Isère, France

Groupe Hospitalier Mutualiste Les Portes du Sud; 🇫🇷 Vénissieux, Rhône-Alpes, France

Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière; 🇫🇷 Paris, France

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-Essonnes, Île-de-France, France

Iatriko Paleou Falirou Medical Center; 🇬🇷 Paleo Faliro, Attikí (Region), Greece

Athens Medical Center; 🇬🇷 Athens, Attikí, Greece

Ippokrateio General Hospital of Thessaloniki; 🇬🇷 Thessaloniki, Kentrikí Makedonía, Greece

Euromedica General Clinic of Thessaloniki; 🇬🇷 Thessaloniki, Thessaloníki, Greece

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; 🇲🇽 Mexico City, Distrito Federal, Mexico

Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente; 🇲🇽 Guadalajara, Jalisco, Mexico

Private Practice - Dr. Arechavaleta Granell Maria del Rosario; 🇲🇽 Guadalajara, Jalisco, Mexico

Unidad de Investigación Clínica y Atención Médica HEPA S.C.; 🇲🇽 Guadalajara, Jalisco, Mexico

CEINV Salud; 🇲🇽 Monterrey, Nuevo León, Mexico

Clínica García Flores SC; 🇲🇽 Monterrey, Nuevo León, Mexico

Medsal Centro Médico; 🇲🇽 Tampico, Tamaulipas, Mexico

Enclifar Ensayos Clínicos Farmacológicos Sc; 🇲🇽 Chihuahua, Mexico

Consultorio Médico de Endocrinología y Pediatría; 🇲🇽 Puebla, Mexico

Mariodiab Clinic; 🇷🇴 Brasov, Brașov, Romania

Sanamed Hospital; 🇷🇴 Bucharest, București, Romania

Rinart Diab SRL; 🇷🇴 Targoviste, Dâmbovița, Romania

Centrul medical DiabNutriMed; 🇷🇴 Bucharest, Ilfov, Romania

CMI DNBM Dr. Pop Lavinia; 🇷🇴 Baia Mare, Maramureș, Romania

Diabet Med; 🇷🇴 București, Romania

Diamed Obesity; 🇷🇴 Galați, Romania

Centrul Medical Consultmed; 🇷🇴 Iași, Romania

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona [Barcelona], Spain

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Catalunya [Cataluña], Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Madrid, Comunidad de, Spain

Hospital Infanta Cristina; 🇪🇸 Badajoz, Spain

Hospital Universitario Virgen Del Rocio; 🇪🇸 Sevilla, Spain