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

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.

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Key information

Conditions

Type 1 Diabetes Mellitis

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil, Neuss, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GZR-33

Drug

GZR33 is a long-acting basal insulin analogue

Primary outcomes

the relative potency of GZR33 to insulin degludec

Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Andre Feldmann

CONTACT

[email protected]

+49 (0) 2131 4018 409

Sponsors and collaborators

Lead sponsor

Gan and Lee Pharmaceuticals, USA

Industry

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Nov 21, 2025
Registry last updated: Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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