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

A Phase III Clinical Study Comparing the Efficacy and Safety of Once-weekly GZR4 Versus Once-daily Insulin Degludec With or Without Non-Insulin Antidiabetic Agents in Subjects With Type 2 Diabetes Mellitus (T2DM) Treated With Basal Insulin

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 620 (estimated)
• Sponsor: Gan & Lee Pharmaceuticals. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes

Interventions

Type	Name	Description
DRUG	GZR4	GZR4 s.c., once-weekly，treat-to-target dose
DRUG	insulin degludec	insulin degludec s.c.,once-daily，treat-to-target dose

Timeline

• Start date: 2025-02-15
• Primary completion: 2026-02-07
• Completion: 2026-02-28
• First posted: 2025-01-10
• Last updated: 2025-11-21

Locations

1 site across 1 country: China