drugset / Trial / NCT06767735

A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Insulin-naive Subjects With Type 2 Diabetes Mellitus (T2DM)

NCT06767735

Phase 3 Active not recruiting 580 enrolled Gan & Lee Pharmaceuticals.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will be conducted to compare the efficacy, safety and patient-reported outcome of once-weekly GZR4 and once-daily Insulin Glargine U100 with Non-Insulin Antidiabetic Agents in Insulin-naive Subjects with Type 2 Diabetes Mellitusin.

Timeline

Start
2025-02-17
Primary completion
2026-08-01
Completion
2026-08-17

Drugs

EvaluationDrugModalityDoseRoute
Subject GZR4 Unknown Subcutaneous
Comparator Insulin glargine U100 Protein / enzyme biologic Subcutaneous

Indications