drugset / Trial / NCT07165223

A Phase IIIb Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin

NCT07165223

Phase 3 Recruiting 300 enrolled Gan & Lee Pharmaceuticals.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will be conducted to compare the efficacy, safety and patient-reported outcome of GZR4 and Insulin Icodec with or without Non-Insulin Antidiabetic Agents in subjects with Type 2 Diabetes Mellitus (T2DM) treated with basal insulin.

Timeline

Start
2025-10-17
Primary completion
2026-11-10
Completion
2026-11-10

Drugs

EvaluationDrugModalityDoseRoute
Subject GZR4 Unknown Subcutaneous
Comparator Insulin icodec Protein / enzyme biologic Subcutaneous

Indications