Type 2 DiabetesPhase 1NCT06548997
A Phase I Study of GZR18 Injection in Healthy Subjects
A Phase 1 study testing GZR18 in people with Type 2 Diabetes and Overweight and Obesity, 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 evaluate the safety and tolerability of GZR18 injection in healthy subjects following single dose and once-weekly dose for 2 consecutive weeks until reaching the target dose. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Overweight and Obesity
- What is being tested?
- GZR18
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 2 Dec 2021to 20 Oct 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Subjects sign informed consent voluntarily.
- 2. Chinese adult subjects, male or female.
- 3. Age 18-55 at screening (both included).
- 4. At screening and baseline, 19.0 kg/m2 ≤ BMI ≤ 26.0 kg/m2 (male ≥55.0 kg, female ≥45.0 kg).
- 5. Female subjects were human chorionic gonadotophin (HCG) negative at screening and baseline.
Who cannot join
- 1. History of dizziness with blood and needles.
- 2. Known or suspected allergy to study related products; or a history of drug and food allergies; or a history of allergy-related diseases.
- 3. Participants who participated in other clinical trials and were given the investigational drug or medical device intervention within 90 days prior to screening.
- 4. Blood donation, surgery, or trauma with significant blood loss (more than or equal to 400 mL, except for menstrual blood loss in women) within 12 weeks prior to screening.
- 5. Any clinically significant medical history judged by the investigator, including but not limited to: lung, gastrointestinal, liver, nervous system, kidney, genitourinary and endocrine, skin, or blood disorders, especially a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 , and a history of pancreatitis (acute or chronic).
- 6. At screening or baseline, physical examination showed clinically significant abnormalities judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GZR18 Injection in Healthy Subjects Following Single Dose and Once-weekly Dose for 2 Consecutive Weeks Until Reaching the Target Dose
This trial is conducted in China. The aim of the trial is to evaluate the safety and tolerability of GZR18 injection in healthy subjects following single dose and once-weekly dose for 2 consecutive weeks until reaching the target dose.
- Conditions
- Type 2 Diabetes, Overweight and Obesity
- Being tested
- GZR18, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZR18Drug
5 μg/kg-maximum tolerated dose (MTD), single dose or two doses
PlaceboOther
administered the same volume as GZR18
| Study group | Role | What they receive |
|---|---|---|
| GZR18 | Experimental | Not described Receives: Drug: GZR18 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEAE
Incidence of treatment-emergent adverse events (TEAE)
Measured: after 28/35 days of treatment
Secondary outcomes (16)
Cmax
The peak concentration after reaching the target dose
Measured: 28/35 days
AUClast
the area under the concentration-time curve from 0 to the last time that the concentration can be accurately measured
Measured: 28/35 days
AUC0-inf
the area under the concentration-time curve from 0 to infinity
Measured: 28/35 days
Tmax
the peak time
Measured: 28/35 days
λz
the elimination rate constant
Measured: 28/35 days
t1/2
the half-life
Measured: 28/35 days
tlag
retention time
Measured: 28/35 days
CL/F
apparent clearance rate
Measured: 28/35 days
Vz/F
apparent volume of distribution
Measured: 28/35 days
AUC%extra
extrapolation percentage of AUC0-in
Measured: 28/35 days
MRT
average retention time
Measured: 28/35 days
AUCglucose0-14h
area under the concentration-time curve of fasting blood glucose from 0 to 14 hours after each administration
Measured: 28/35 days
AUCc-peptide0-14h
area under the concentration-time curve of fasting C-peptide from 0 to 14 hours after each administration
Measured: 28/35 days
AUCinsulin0-14h
area under the concentration-time curve of fasting insulin from 0 to 14 hours after each administration
Measured: 28/35 days
body weight
Measured: 28/35 days
body mass index (BMI）
Measured: 28/35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start2 Dec 2021
- Primary completion20 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gan and Lee Pharmaceuticals, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liyuan Zhao, Ph.D, Study director, Gan & Lee Pharmaceuticals.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548997
- Sponsor's protocol ID
- GL-GLP-CH1002
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 14 Aug 2024
- 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 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GZR18 Injection in Healthy Subjects Following Single Dose and Once-weekly Dose for 2 Consecutive Weeks Until Reaching the Target Dose
- ClinicalTrials.gov ID
- NCT06548997
- Acronym / sponsor ID
- GL-GLP-CH1002
- Conditions
- Type 2 Diabetes, Overweight and Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Gan and Lee Pharmaceuticals, USAIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 12 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 evaluate the safety and tolerability of GZR18 injection in healthy subjects following single dose and once-weekly dose for 2 consecutive weeks until reaching the target dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GZR18 | Experimental | Drug: GZR18 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. Subjects sign informed consent voluntarily.
- 2. Chinese adult subjects, male or female.
- 3. Age 18-55 at screening (both included).
- 4. At screening and baseline, 19.0 kg/m2 ≤ BMI ≤ 26.0 kg/m2 (male ≥55.0 kg, female ≥45.0 kg).
- 5. Female subjects were human chorionic gonadotophin (HCG) negative at screening and baseline.
Key exclusion criteria (6 listed)
- 1. History of dizziness with blood and needles.
- 2. Known or suspected allergy to study related products; or a history of drug and food allergies; or a history of allergy-related diseases.
- 3. Participants who participated in other clinical trials and were given the investigational drug or medical device intervention within 90 days prior to screening.
- 4. Blood donation, surgery, or trauma with significant blood loss (more than or equal to 400 mL, except for menstrual blood loss in women) within 12 weeks prior to screening.
- 5. Any clinically significant medical history judged by the investigator, including but not limited to: lung, gastrointestinal, liver, nervous system, kidney, genitourinary and endocrine, skin, or blood disorders, especially a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 , and a history of pancreatitis (acute or chronic).
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 |
|---|---|---|
| GZR185 μg/kg-maximum tolerated dose (MTD), single dose or two doses | Drug | GZR18 |
| Placeboadministered the same volume as GZR18 | Other | Placebo |
Primary outcome
TEAE
Time frame: after 28/35 days of treatment
Incidence of treatment-emergent adverse events (TEAE)
16 secondary outcomes
Cmax
Time frame: 28/35 days
AUClast
Time frame: 28/35 days
AUC0-inf
Time frame: 28/35 days
Tmax
Time frame: 28/35 days
λz
Time frame: 28/35 days
t1/2
Time frame: 28/35 days
tlag
Time frame: 28/35 days
CL/F
Time frame: 28/35 days
Vz/F
Time frame: 28/35 days
AUC%extra
Time frame: 28/35 days
MRT
Time frame: 28/35 days
AUCglucose0-14h
Time frame: 28/35 days
AUCc-peptide0-14h
Time frame: 28/35 days
AUCinsulin0-14h
Time frame: 28/35 days
body weight
Time frame: 28/35 days
body mass index (BMI）
Time frame: 28/35 days
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.
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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.
Liyuan Zhao, Ph.D study director
Gan & Lee Pharmaceuticals.
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 GZR18 in people with Type 2 Diabetes and Overweight and Obesity, 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 5 inclusion and 6 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. Some participants in this study may receive a placebo. 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?
TEAE (time frame: after 28/35 days of treatment). 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.