DiabetesPhase 1NCT06553248
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GZR4 in Subjects With Type 2 Diabetes
A Phase 1 study testing GZR4 and Insulin Degludec in people with Diabetes, run by Gan and Lee Pharmaceuticals, USA at 1 site in China.
Trial summary
This trial is conducted in China. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of mutiple-dose GZR4 in subjects with type 2 diabetes Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes
- What is being tested?
- GZR4 and Insulin Degludec
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2023to 1 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female at the age of 18-65 (inclusive) at the time of informed consent
- Body mass index (BMI) between 18.5 and 35 kg/m2 (inclusive) at screening
- Diagnosis of type 2 diabetes mellitus for over 3 months
- Hemoglobin A1c (HbA1c) ≥ 6.5% and ≤ 10.0% at screening.
Who cannot join
- History of drug abuse within 1 year before screening, or positive drug abuse screening results during the screening period or at baseline
- Malignancy or increased risk of malignancy before screening: any suspected and/or diagnosed malignancy or documented history of malignancy
- Confirmed or suspected type 1 diabetes mellitus, gestational diabetes mellitus, or specific types of diabetes mellitus from other causes (monogenic diabetes syndrome, cystic fibrosis, pancreatitis, drug-induced or chemically induced diabetes mellitus, etc.) prior to screening
- Presence of the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma; proliferative retinopathy or maculopathy that is unstable or requiring treatment; symptomatic diabetic neuropathy, intermittent claudication or diabetic foot
- Severe hypoglycaemic events (Level 3 hypoglycaemia) within 6 months prior to screening, or 3 or more hypoglycaemic events (blood glucose ≤ 3.9 mmol/L) within 1 month prior to screening, or recurrent hypoglycaemia-related symptoms
Trial locations and contacts
1 site in 1 country.
China1 site
Gan & Lee Pharmaceuticals Co., Ltd
Beijing, Beijing Municipality, 100000
About this study
Official title: A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of GZR4 in Chinese Patients With Type 2 Diabetes Mellitus
This trial is conducted in China. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of mutiple-dose GZR4 in subjects with type 2 diabetes
- Conditions
- Diabetes
- Being tested
- GZR4, Insulin Degludec
- Keywords
- GZR4, PK, PD
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZR4Drug
Administered once weekly subcutaneously (s.c., under the skin) for 6 weeks
Insulin DegludecDrug
Administered once daily subcutaneously (s.c., under the skin) for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| GZR4 | Experimental | s.c., once weekly Receives: Drug: GZR4 |
| Insulin Degludec | Active comparator | s.c., once daily Receives: Drug: Insulin Degludec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of TEAE
Measured: Baseline to Week 6
Secondary outcomes (5)
AUC0-inf
Measured: Week 6
AUC0-last
Measured: Week 6
AUC0-168h
Measured: Week 1, Week 6
Tmax,GZR4
Measured: Week 1, Week 6
ADA of GZR4
Measured: Baseline to Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start22 Mar 2023
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
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
- NCT06553248
- Sponsor's protocol ID
- GL-GZR-CH1016
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of GZR4 in Chinese Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06553248
- Acronym / sponsor ID
- GL-GZR-CH1016
- Conditions
- Diabetes
- Keywords
- GZR4, PK, PD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Gan and Lee Pharmaceuticals, USAIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 14 Aug 2024 (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 is conducted in China. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of mutiple-dose GZR4 in subjects with type 2 diabetes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GZR4 | Experimental | Drug: GZR4s.c., once weekly |
| Insulin Degludec | Active comparator | Drug: Insulin Degludecs.c., once daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female at the age of 18-65 (inclusive) at the time of informed consent
- Body mass index (BMI) between 18.5 and 35 kg/m2 (inclusive) at screening
- Diagnosis of type 2 diabetes mellitus for over 3 months
- Hemoglobin A1c (HbA1c) ≥ 6.5% and ≤ 10.0% at screening.
Key exclusion criteria (5 listed)
- History of drug abuse within 1 year before screening, or positive drug abuse screening results during the screening period or at baseline
- Malignancy or increased risk of malignancy before screening: any suspected and/or diagnosed malignancy or documented history of malignancy
- Confirmed or suspected type 1 diabetes mellitus, gestational diabetes mellitus, or specific types of diabetes mellitus from other causes (monogenic diabetes syndrome, cystic fibrosis, pancreatitis, drug-induced or chemically induced diabetes mellitus, etc.) prior to screening
- Presence of the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma; proliferative retinopathy or maculopathy that is unstable or requiring treatment; symptomatic diabetic neuropathy, intermittent claudication or diabetic foot
- Severe hypoglycaemic events (Level 3 hypoglycaemia) within 6 months prior to screening, or 3 or more hypoglycaemic events (blood glucose ≤ 3.9 mmol/L) within 1 month prior to screening, or recurrent hypoglycaemia-related symptoms
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 |
|---|---|---|
| GZR4Administered once weekly subcutaneously (s.c., under the skin) for 6 weeks | Drug | GZR4 |
| Insulin DegludecAdministered once daily subcutaneously (s.c., under the skin) for 6 weeks | Drug | Insulin Degludec |
Primary outcome
Incidence of TEAE
Time frame: Baseline to Week 6
5 secondary outcomes
AUC0-inf
Time frame: Week 6
AUC0-last
Time frame: Week 6
AUC0-168h
Time frame: Week 1, Week 6
Tmax,GZR4
Time frame: Week 1, Week 6
ADA of GZR4
Time frame: Baseline to Week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GZR4 and Insulin Degludec in people with Diabetes, run by Gan and Lee Pharmaceuticals, USA at 1 site in China.
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: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of TEAE (time frame: Baseline to Week 6). 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 14 Aug 2024.