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

Recruiting now · Phase 1

Conditions studied: Type 1 Diabetes Mellitis

In brief

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.

Key facts

Study ID

NCT07242664

Run by

Gan and Lee Pharmaceuticals, USA

People needed

12

Starts

2025-10-13

Expected to finish

2026-04-15

Last updated by the study team

2025-11-21

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• Profil Institut — Neuss, Germany (enrolling)
• Profil — Neuss, Germany (enrolling)

Full record on ClinicalTrials.gov

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