A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight (I8F-MC-GPJA)

Not yet recruiting

• Conditions: Type 1 Diabetes Obesity Overweight

• Registration Number: jRCT2031250060
• Lead Sponsor: Eli Lilly Japan K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-28
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 905

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 assignment

Primary Outcome Measures

Name	Time	Method
-		Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 40