Type 1 Diabetes MellitisPhase 1NCT07242664
Clamp Study to Estimate the Relative Potency of GZR33 Versus Insulin Degludec at Steady State
A Phase 1 study testing GZR-33 in people with Type 1 Diabetes Mellitis, run by Gan and Lee Pharmaceuticals, USA at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Type 1 Diabetes Mellitis
- What is being tested?
- GZR-33
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesGermany
- Study dates
- 13 Oct 2025to 15 Apr 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Profil Institut
Neuss, 41460
- Recruiting
Profil
Neuss
Andre Feldmann, +49 (0) 2131 4018 409, 149-1226-GZR-33@profil.com
About this study
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
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.
- Conditions
- Type 1 Diabetes Mellitis
- Being tested
- GZR-33
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZR-33Drug
GZR33 is a long-acting basal insulin analogue
| Study group | Role | What they receive |
|---|---|---|
| Period 1 - GZR-33, period 2 insulin degludec | Experimental | Period 1 - GZR-33 once daily for six days. Post wash-out, insulin degludec once daily for six days Receives: Drug: GZR-33 |
| Period 1 - insulin degludec, period 2 - GZR-33 | Experimental | Period 1 - insulin degludec once daily for six days. Post wash-out, GZR-33 once daily for six days Receives: Drug: GZR-33 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the relative potency of GZR33 to insulin degludec
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).
Measured: a two week run-in phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start13 Oct 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gan and Lee Pharmaceuticals, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242664
- Sponsor's protocol ID
- GZR33-T1D-US101
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07242664
- Acronym / sponsor ID
- GZR33-T1D-US101
- Conditions
- Type 1 Diabetes Mellitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Gan and Lee Pharmaceuticals, USAIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1 - GZR-33, period 2 insulin degludec | Experimental | Drug: GZR-33Period 1 - GZR-33 once daily for six days. Post wash-out, insulin degludec once daily for six days |
| Period 1 - insulin degludec, period 2 - GZR-33 | Experimental | Drug: GZR-33Period 1 - insulin degludec once daily for six days. Post wash-out, GZR-33 once daily for six days |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GZR-33GZR33 is a long-acting basal insulin analogue | Drug | Period 1 - GZR-33, period 2 insulin degludec, Period 1 - insulin degludec, period 2 - GZR-33 |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GZR-33 in people with Type 1 Diabetes Mellitis, run by Gan and Lee Pharmaceuticals, USA at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andre Feldmann (+49 (0) 2131 4018 409, 149-1226-GZR-33@profil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the relative potency of GZR33 to insulin degludec (time frame: a two week run-in phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.