RecruitingPhase 1NCT07242664

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


Sponsor

Gan and Lee Pharmaceuticals, USA

Enrollment

12 participants

Start Date

Oct 13, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing the strength (potency) of a new experimental insulin called GZR33 versus insulin degludec (a long-acting insulin already in use) in people with Type 1 diabetes. The study uses a specialized technique called a glucose clamp, which measures how much glucose the body needs to maintain steady blood sugar levels at different insulin doses. **You may be eligible if...** - You have had Type 1 diabetes for at least 12 months - You are 18 to 64 years old - Your HbA1c (average blood sugar level) is 9.0% or below - Your BMI is between 18.5 and 29.0 kg/m² - You have been on a stable insulin regimen for at least 2 months **You may NOT be eligible if...** - Your blood pressure falls outside normal ranges - You have other significant health conditions - You have had repeated severe low blood sugar episodes (more than 1 episode requiring help in the past 6 months) - You are unaware when your blood sugar is going low (hypoglycemia unawareness) - Your kidney function is reduced (eGFR below 60) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGZR-33

GZR33 is a long-acting basal insulin analogue


Locations(2)

Profil Institut

Neuss, Germany

Profil

Neuss, Germany

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NCT07242664


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