NCT07242664RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- 13 Oct 2025
- Primary completion date
- 28 Feb 2026
- Lead sponsor
- Gan and Lee Pharmaceuticals, USA
- Diseases
- Type 1 diabetes
- NCT number
- NCT07242664
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 12
- From 13 Oct 2025 to the primary completion date, 28 Feb 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- clinically significant concomitant diseases
- recurrent severe hypoglycemia (more than 1 severe hypoglycemic episode requiring assistance from another person within 180 days before screening)
Lab values
- estimated glomerular filtration rate (eGFR) \<60.0 mL/min/1.73 m2
Other
- blood pressure outside the range 90 to 140 mmHg (systolic) or 50 to 99 mmHg (diastolic)
- hypoglycemia unawareness
Who the study is looking for
- 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
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Profil Institut Coordinator of this site? Confirm its status | Neuss | Germany | Recruiting |
| Profil Coordinator of this site? Confirm its status | Neuss | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.