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Clinical Trials in Germany / NCT07242664
Recruiting Phase 1

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

NCT07242664 · tracked via the Priya Life Science Germany tracker
Sponsor
Gan and Lee Pharmaceuticals, USA
Phase
Phase 1
Started
2025-10-13
Last updated
2025-11-21

Condition(s) studied

Type 1 Diabetes Mellitis

Investigational drug(s) / intervention(s)

GZR-33

GZR-33: GZR33 is a long-acting basal insulin analogue

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
64 Years
Healthy volunteers
No
Inclusion Criteria: type 1 diabetes for at least 12 months * 18-64 years of age * HbA1c \<= 9.0%. * Body Mass Index (BMI) between 18.5 and 29.0 kg/m\^2 * treated with a stable insulin regimen for at least 2 months, in a dose \> 0.2 and \< 1.2 U/kg/day Exclusion Criteria: * blood pressure outside the range 90 to 140 mmHg (systolic) or 50 to 99 mmHg (diastolic) * clinically significant concomitant diseases * recurrent severe hypoglycemia (more than 1 severe hypoglycemic episode requiring assistance from another person within 180 days before screening) * hypoglycemia unawareness * estimated glomerular filtration rate (eGFR) \<60.0 mL/min/1.73 m2

Primary outcome measure(s)

  • the relative potency of GZR33 to insulin degludec — a two week run-in phase
    Primary endpoint will be the relative potency of GZR33 to insulin degludec, according to the following equation: Relative Potency = GIR24h,ss,GZR33 /GIR24h,ss,degludec) × (Dosedegludec/DoseGZR33).

Trial sites (2)

FacilityCityRegionStatus
Profil Institut Neuss Germany Recruiting
Profil Neuss Germany Recruiting

More Gan and Lee Pharmaceuticals, USA trials in Germany

Comparison Study of Insulin GZR4 With Insulin Degludec Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07242664 on ClinicalTrials.gov ↗ ← All trials in Germany