Comparing the potency of a new insulin (GZR33) with insulin degludec at steady state
Official 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
Run by Gan and Lee Pharmaceuticals, USA · NCT07242664 · Data updated 2026-11-12
This trial will test whether the new insulin GZR33 has similar blood-sugar–lowering strength to insulin degludec in adults with type 1 diabetes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Gan and Lee Pharmaceuticals, USA Industry-sponsored |
| Locations | 2 sites (Neuss and 1 other locations) |
| Status | Recruiting |
| Started | October 13, 2025 |
| Main results expected | February 28, 2026 |
| Study ends | April 15, 2026 |
| Registry record updated | November 21, 2025 |
| Trial ID | NCT07242664 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 18–64 with type 1 diabetes for at least 12 months, HbA1c ≤9.0%, BMI 18.5–29.0 kg/m2, on a stable insulin regimen (0.2–1.2 U/kg/day), and without major comorbidities, kidney impairment, recurrent severe hypoglycemia, or hypoglycemia unawareness.
✕Probably not a fit
Patients with eGFR <60 mL/min/1.73 m2, recurrent severe hypoglycemia, hypoglycemia unawareness, uncontrolled blood pressure, significant concomitant diseases, or those outside the age/BMI limits are unlikely to be eligible or to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this Phase 1 interventional clamp study, adults with type 1 diabetes on stable insulin regimens will receive GZR33 and insulin degludec to reach steady state while undergoing glucose clamp procedures to measure glucose-lowering potency. Investigators will collect pharmacodynamic and pharmacokinetic data and monitor safety and tolerability during and after dosing. Eligible participants are adults 18–64 years with type 1 diabetes for at least 12 months, HbA1c ≤9.0%, BMI 18.5–29.0 kg/m2, and on a stable insulin dose within the specified range, while those with significant comorbidities, reduced kidney function, recurrent severe hypoglycemia, or hypoglycemia unawareness are excluded. The trial is conducted at Profil Institut in Neuss using controlled clamp conditions to enable a precise potency comparison at steady state.
Why it matters
Potential benefit: If successful, GZR33 could become an alternative basal insulin with comparable or improved potency and tolerability versus degludec.
How similar studies have gone: Glucose clamp comparisons are the standard for early-phase insulin development and have reliably characterized relative potency for other insulin analogues, but GZR33 itself is being tested here for the first time in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Profil Institut
Neuss, Germany Recruiting -
Profil
Neuss, Germany Recruiting
Study contacts
- Study coordinator: Andre Feldmann
- Email: 149-1226-GZR-33@profil.com
- Phone: +49 (0) 2131 4018 409
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.