A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Tirzepatide Once Weekly Compared to Placebo in Adult Participants With Type 1 Diabetes and Obesity or Overweight (I8F-MC-GPJA )

Eli Lilly Japan K.K.0 个研究点目标入组 905 人开始时间: 待定最近更新: 2025年5月22日

试验速览

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•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

•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

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

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