NCT07242664

Clamp Study to Estimate the Relative Potency of GZR33 Versus Insulin Degludec at Steady State

A Trial to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Insulin GZR33 Compared With Insulin Degludec at Steady State in Participants With Type 1 Diabetes

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Gan and Lee Pharmaceuticals, USA · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This trial intends to investigate the pharmacodynamics, pharmacokinetics, safety, and tolerability of insulin GZR33 (hereafter referred to as GZR33) and estimate its potency in comparison with insulin degludec.

Conditions

• Type 1 Diabetes Mellitis

Interventions

Type	Name	Description
DRUG	GZR-33	GZR33 is a long-acting basal insulin analogue

Timeline

• Start date: 2025-10-13
• Primary completion: 2026-02-28
• Completion: 2026-04-15
• First posted: 2025-11-21
• Last updated: 2025-11-21

Locations

2 sites across 1 country: Germany