drugset / Trial / NCT06256523

A Study of GZR18 Injection in Chinese Adult Patients With Type 2 Diabetes Mellitus (T2DM)

NCT06256523

Phase 1/2 Completed 72 enrolled Gan and Lee Pharmaceuticals, USA
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled Phase Ib/IIa clinical study in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise and/or treated with irregular use of antidiabetic drugs to evaluate the safety, tolerability, pharmacokinetics and efficacy of GZR18 injection in adult subjects with T2DM. This study is divided into Part A and Part B, which are to be conducted simultaneously.

Timeline

Start
2022-06-29
Primary completion
2023-09-28
Completion
2023-09-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Bofanglutide Protein / enzyme biologic 4 mg Subcutaneous
Subject Bofanglutide Protein / enzyme biologic 13 mg Subcutaneous