Tirzepatide Launches Phase II Clinical Trial for Type 1 Diabetes with Obesity

Recently, a Phase II clinical trial of Tirzepatide for the treatment of subjects with both Type 1 diabetes and obesity was registered on the ClinicalTrials.gov official website.

This is a randomized, double-blind Phase II clinical trial designed to evaluate the efficacy of tirzepatide combined with insulin compared to insulin alone in treating patients with type 1 diabetes and obesity. The study enrolled 36 participants who were randomly assigned in a 1:1 ratio to receive either insulin or insulin plus tirzepatide.

The study starts in March 2024 and ends in July 2025. The primary endpoint is the change in subjects' body weight, and secondary endpoints include levels of glycated hemoglobin (HbA1c), total daily insulin dose, waist circumference, neck circumference, blood pressure, etc.

Tirzepatide is a once-weekly GIPR and GLP-1R agonist that was first approved by the FDA in May 2022 for the treatment of type 2 diabetes and received an expanded indication for obesity in November this year.

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