Clinical trial

A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight

Active, not recruiting · Phase 3 · 4 countries · Registry ID NCT06914895

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 in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 49 weeks.

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

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

CENUDIAB🇦🇷 Buenos Aires, Argentina
CIPREC🇦🇷 Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)🇦🇷 Buenos Aires, Argentina
Consultorio de Investigación Clínica EMO SRL🇦🇷 Buenos Aires, Argentina
Investigaciones Medicas Imoba Srl🇦🇷 Buenos Aires, Argentina
Centro Medico Privado San Vicente Diabetes🇦🇷 Córdoba, Argentina
Instituto de Investigaciones Clínicas Córdoba🇦🇷 Córdoba, Argentina
Centro de Investigaciones Médicas Mar del Plata🇦🇷 Mar del Plata, Argentina
Fundacion Estudios Clinicos🇦🇷 Rosario, Argentina
Instituto Médico Río Cuarto🇦🇷 Río Cuarto, Argentina
Centro de Diagnóstico y Rehabilitación (CEDIR)🇦🇷 Santa Fe, Argentina
Centro de Salud e Investigaciones Médicas🇦🇷 Santa Rosa, Argentina
Centro de Diabetes Curitiba🇧🇷 Curitiba, Brazil
Centro De Diabetes Metabolismo E Endocrinologia🇧🇷 Fortaleza, Brazil
Private Practice - Dr.Miguel N. Hissa🇧🇷 Fortaleza, Brazil
Universidade Federal de Goias🇧🇷 Goiânia, Brazil
CEPIC - Centro Paulista de Investigação Clínica🇧🇷 São Paulo, Brazil
CPCLIN🇧🇷 São Paulo, Brazil
CPQuali Pesquisa Clínica🇧🇷 São Paulo, Brazil
Hospital das Clinicas FMUSP🇧🇷 São Paulo, Brazil
IBTED - Tecnologia e Educação em Diabetes🇧🇷 São Paulo, Brazil
CEDOES🇧🇷 Vitória, Brazil
Esbjerg sygehus, Syddansk Universitetshospital🇩🇰 Esbjerg, Denmark
Steno Diabetes Center - Copenhagen🇩🇰 Herlev, Denmark
Regionshospitalet Gødstrup🇩🇰 Herning, Denmark
Nordsjællands Hospital - Hillerød🇩🇰 Hillerød, Denmark
Sjællands Universitetshospital Køge🇩🇰 Køge, Denmark
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre🇫🇷 Caen, France
Centre Hospitalier Sud Francilien🇫🇷 Corbeil-Essonnes, France
Hôtel-Dieu du Creusot - site Harfleur🇫🇷 Le Creusot, France
Centre du diabète DIAB-eCARE🇫🇷 Lyon, France
Hôpital Européen Marseille🇫🇷 Marseille, France
Hôpital de la Conception🇫🇷 Marseille, France
CHU Montpellier Lapeyronie Hospital🇫🇷 Montpellier, France
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes🇫🇷 Nantes, France
Hôpital NOVO🇫🇷 Pontoise, France
CHU Strasbourg-Hautepierre🇫🇷 Strasbourg, France
Centre Hospitalier intercommunal de Toulon La Seyne sur Mer🇫🇷 Toulon, France
CHU Rangueil🇫🇷 Toulouse, France
Groupe Hospitalier Mutualiste Les Portes du Sud🇫🇷 Vénissieux, France