Clinical trial

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

Active, not recruiting · Phase 3 · 7 countries · Registry ID NCT06962280

Active, not recruitingPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionType 1 Diabetes, Obesity, Overweight

Full registry 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

Treatments and study arms

Tirzepatide

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

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

Study locations

79 locations were listed when this page was built. The first 40 are shown.

Buenos Aires Macula S.A🇦🇷 Buenos Aires, Argentina
Mautalen Salud e Investigación🇦🇷 Buenos Aires, Argentina
Stat Research S.A.🇦🇷 Buenos Aires, Argentina
Centro Diabetológico Dr. Waitman🇦🇷 Córdoba, Argentina
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes🇦🇷 Godoy Cruz, Argentina
Centro de Investigaciones Clínicas Baigorria🇦🇷 Granadero Baigorria, Argentina
Instituto Médico Catamarca IMEC🇦🇷 Rosario, Argentina
Investigaciones Clínicas Tucumán🇦🇷 San Miguel de Tucumán, Argentina
Centro de Pesquisa Clinica do Brasil🇧🇷 Brasília, Brazil
Centro de Pesquisa Sao Lucas🇧🇷 Campinas, Brazil
Quanta Diagnóstico e Terapia🇧🇷 Curitiba, Brazil
Cendi - Endocrinologia e Diabetes🇧🇷 Goiânia, Brazil
Instituto da Crianca com Diabetes🇧🇷 Porto Alegre, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica🇧🇷 Rio de Janeiro, Brazil
CEPIC - Centro Paulista de Investigação Clínica🇧🇷 São Paulo, Brazil
CPCLIN🇧🇷 São Paulo, Brazil
Endocrinologie Oasis🇨🇦 Montreal, Canada
Centricity Research Ottawa LMC Endocrinology🇨🇦 Ottawa, Canada
Centre de Recherche Saint-Louis🇨🇦 Sherbrooke, Canada
TLC Diabetes and Endocrinology🇨🇦 Surrey, Canada
Care Access - Cape Breton🇨🇦 Sydney, Canada
INTENDIA klinika s.r.o.🇨🇿 Chrudim III, Czechia
AIDIN VK s.r.o.🇨🇿 Hranice, Czechia
MUDr. Tomas Edelsberger🇨🇿 Krnov, Czechia
Diabetologicke centrum s.r.o.🇨🇿 Olomouc, Czechia
Milan Kvapil s.r.o., Diabetologicka ambulance🇨🇿 Prague, Czechia
ResTrial s.r.o.🇨🇿 Prague, Czechia
Centre Hospitalier Universitaire - Hôpitaux de Rouen - Hôpital de Bois-Guillaume🇫🇷 Bois-Guillaume, France
Centre Hospitalier Sud Francilien🇫🇷 Corbeil-Essonnes, France
Centre Hospitalier Universitaire de Grenoble🇫🇷 Grenoble, France
Hôtel-Dieu du Creusot - site Harfleur🇫🇷 Le Creusot, France
Hôpital de la Conception🇫🇷 Marseille, France
Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière🇫🇷 Paris, France
CHU Rangueil🇫🇷 Toulouse, France
Groupe Hospitalier Mutualiste Les Portes du Sud🇫🇷 Vénissieux, France
Athens Medical Center🇬🇷 Athens, Greece
Iatriko Paleou Falirou Medical Center🇬🇷 Palaió Fáliro, Greece
Euromedica General Clinic of Thessaloniki🇬🇷 Thessaloniki, Greece
Ippokrateio General Hospital of Thessaloniki🇬🇷 Thessaloniki, Greece
Enclifar Ensayos Clínicos Farmacológicos Sc🇲🇽 Chihuahua City, Mexico