drugset / Trial / NCT06767748

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

NCT06767748 ↗

Phase 3 Active not recruiting 620 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 Degludec with or without Non-Insulin Antidiabetic Agents in subjects with Type 2 Diabetes Mellitus (T2DM) treated with basal insulin.

Timeline

Start
2025-02-15
Primary completion
2026-02-07
Completion
2026-02-28

Outcome

Met primary endpoint

release “two pivotal phase 3 clinical trials, SUPER-1 and SUPER-2, evaluating investigative once-weekly insulin GZR4 Injection, have successfully met their pre-specified primary endpoints.” ganlee.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject GZR4 Unknown — Subcutaneous
Comparator insulin degludec Protein / enzyme biologic — Subcutaneous