NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Type 1 Diabetes Obesity Overweight
Date of first enrollment	20/05/2025
Target sample size	905
Countries of recruitment	United States,Japan,Argentina,Japan,Brazil,Japan,Denmark,Japan,France,Japan,Germany,Japan,Israel,Japan,Italy,Japan,Mexico,Japan,Puerto Rico,Japan,Spain,Japan
Study type	Interventional
Intervention(s)	DRUG: Tirzepatide(Other Name: LY3298176) Administered SC DRUG: Placebo Administered SC (Study Arms) Experimental: Tirzepatide Dose 1 Participants will receive tirzepatide subcutaneously (SC) Interventions: Drug: Tirzepatide Experimental: Tirzepatide Dose 2 Participants will receive tirzepatide SC Interventions: Drug: Tirzepatide Experimental: Tirzepatide Dose 3 Participants will receive tirzepatide SC Interventions: Drug: Tirzepatide Experimental: Tirzepatide Dose 4 Participants will receive tirzepatide SC Interventions: Drug: Tirzepatide Placebo Comparator: Placebo Participants will receive placebo SC Interventions: Drug: Placebo

Outcome(s)

Primary Outcome	Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 40
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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
Exclude 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