Overweight and ObesityPhase 1NCT06548945
A Phase I Study of GZR18 Injection in Obese/Overweight Subjects
A Phase 1 study testing GZR18 in people with Overweight and Obesity, run by Gan and Lee Pharmaceuticals, USA at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study. A sequential design is used in this trial with a single dose escalation climb test, to investigate the safety, tolerability, and PK/PD characteristics of GZR18 injection in Chinese obese/overweight subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- GZR18
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2023to 14 Aug 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
- Subjects sign the informed consent form (ICF) voluntarily.
- Chinese adult subjects, both male and female.
- 18 to 65 years old (including both ends) at screening.
- BMI≥26.0 kg/m2 at screening.
- Stable weight before screening (i.e. self-reported weight change less than 5 kg within 8 weeks before screening).
- Female subjects have negative serum Human Chorionic Gonadotropin (HCG) during screening and baseline periods.
- Subjects have good daily habits and can maintain good communication with investigators and comply with various requirements of clinical trials.
Who cannot join
- Lactating women.
- History of fainting with blood and needles.
- Known or suspected allergy to study related products; or drug/food allergy history; or allergy-related diseases history.
- Subjects who have participated in other clinical trials and given investigational drugs or medical device interventions within 90 days before screening.
- History of drug abuse within 1 year before screening, or positive results in drug abuse screening (urine).
- Smokers who smoke ≥ 5 cigarettes per day within the previous 3 months before screening or cannot refrain from smoking throughout the trial period.
- Any vaccine has been used within 28 days before administration, as well as any vaccine that may be used throughout the trial period.
- Other scenarios judged by the investigator to render the subjects unsuitable for participating in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (PK/PD) of a Single Dose of GZR18 Injection in Obese/Overweight Subjects
This is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study. A sequential design is used in this trial with a single dose escalation climb test, to investigate the safety, tolerability, and PK/PD characteristics of GZR18 injection in Chinese obese/overweight subjects.
- Conditions
- Overweight and Obesity
- Being tested
- GZR18, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZR18Drug
5 mg-maximum tolerated dose (MTD), single dose
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 Event(s)
Measured: 50 days
Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab)
Measured: 50 days
Secondary outcomes (13)
Cmax
Maximum plasma drug concentration
Measured: 50 days
AUClast
area under the curve from 0 through the time of the last accurately measurable concentration
Measured: 50 days
AUC0-inf
area under the curve extrapolated to infinity
Measured: 50 days
Tmax
time to maximum plasma drug concentration
Measured: 50 days
λz
elimination rate constant
Measured: 50 days
t1/2
half-life
Measured: 50 days
tlag
lag time
Measured: 50 days
CL/F
apparent clearance
Measured: 50 days
Vz/F
volume of distribution/F
Measured: 50 days
AUC%extra
percent of AUC0-inf extrapolated
Measured: 50 days
MRT
mean residence time
Measured: 50 days
Weight
Measured: 50 days
Body Mass Index (BMI)
Measured: 50 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 start25 Apr 2023
- Primary completion14 Aug 2023
- Study completion14 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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
- 16 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
- NCT06548945
- Sponsor's protocol ID
- GL-GLP-CH1017
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- 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 Randomized, Double-Blind, Placebo-Controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (PK/PD) of a Single Dose of GZR18 Injection in Obese/Overweight Subjects
- ClinicalTrials.gov ID
- NCT06548945
- Acronym / sponsor ID
- GL-GLP-CH1017
- Conditions
- Overweight and Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Gan and Lee Pharmaceuticals, USAIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 14 Aug 2023 (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 is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study. A sequential design is used in this trial with a single dose escalation climb test, to investigate the safety, tolerability, and PK/PD characteristics of GZR18 injection in Chinese obese/overweight subjects.
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 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects sign the informed consent form (ICF) voluntarily.
- Chinese adult subjects, both male and female.
- 18 to 65 years old (including both ends) at screening.
- BMI≥26.0 kg/m2 at screening.
- Stable weight before screening (i.e. self-reported weight change less than 5 kg within 8 weeks before screening).
Key exclusion criteria (8 listed)
- Lactating women.
- History of fainting with blood and needles.
- Known or suspected allergy to study related products; or drug/food allergy history; or allergy-related diseases history.
- Subjects who have participated in other clinical trials and given investigational drugs or medical device interventions within 90 days before screening.
- History of drug abuse within 1 year before screening, or positive results in drug abuse screening (urine).
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 mg-maximum tolerated dose (MTD), single dose | Drug | GZR18 |
| Placeboadministered the same volume as GZR18 | Other | Placebo |
Primary outcome
TEAE
Time frame: 50 days
Incidence of Treatment Emergent Adverse Event(s)
Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab)
Time frame: 50 days
13 secondary outcomes
Cmax
Time frame: 50 days
AUClast
Time frame: 50 days
AUC0-inf
Time frame: 50 days
Tmax
Time frame: 50 days
λz
Time frame: 50 days
t1/2
Time frame: 50 days
tlag
Time frame: 50 days
CL/F
Time frame: 50 days
Vz/F
Time frame: 50 days
AUC%extra
Time frame: 50 days
MRT
Time frame: 50 days
Weight
Time frame: 50 days
Body Mass Index (BMI)
Time frame: 50 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 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 7 inclusion and 8 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: 50 days). The study lists 2 primary outcomes in all. 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.