NCT07146347

Comparison Study of Insulin GZR4 With Insulin Degludec

A Trial to Evaluate Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Insulin GZR4 Compared With Insulin Degludec and Insulin Icodec in Participants With Type 2 Diabetes

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Gan and Lee Pharmaceuticals, USA · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

In this study, the investigational product will be compared with insulin degludec (Tresiba®) and insulin icodec (Awiqli®). The comparator products are approved for the treatment of T2DM in the European Union.

Detailed description

This trial intends to investigate the pharmacodynamics, pharmacokinetics, safety, and tolerability of insulin GZR4 (hereafter referred to as GZR4) and estimate its potency in comparison with insulin degludec.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	GZR4 injection	GZR4 is a new ultra-long-acting insulin analog

Timeline

• Start date: 2025-08-15
• Primary completion: 2026-04-01
• Completion: 2026-06-01
• First posted: 2025-08-28
• Last updated: 2025-08-28

Locations

1 site across 1 country: Germany