OverweightPhase 1NCT07119450
The Study of [14C] GZR18
A Phase 1 study testing GZR18 injection、[14C]GZR18 injection in people with Overweight and Obese, run by Gan & Lee Pharmaceuticals. at 1 site in China.
Trial summary
This trial is a Single-center, non-randomized, open-label, single-dose Mass Balance Study. The study period of each subject consists of a screening period (D-21 to D-2), a baseline period (D-2 to D-1), a dosing and routine collection period (D1 to D36) and an intermittent collection and follow-up period (D36 to D78… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Overweight, Obese, Obesity
- What is being tested?
- GZR18 injection、[14C]GZR18 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2025to 13 Aug 2025
- 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
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must be fully informed, know and understand the content, process and possible treatment-related adverse events (TRAEs) before the study, and voluntarily sign a written informed consent form;
- Chinese adult male subjects aged 18-55 (inclusive);
- Body weight ≥ 50 kg;
- Subjects with stable physical activity and lifestyle and relatively stable weight within 3 months prior to screening (as per inquiry);
- Subjects have no sperm donation plan within 6 months after the last dose, and subjects and their partners have no pregnancy plan throughout the study and within 6 months after the last dose and voluntarily take effective contraceptive measures to avoid pregnancy of their partners.
Who cannot join
- Subjects with other clinically significant diseases or medical history that may hinder the subject from following the study protocol and completing this study as judged by the investigator.
- Subjects with abnormalities in vital signs, physical examination, routine laboratory tests (hematology, urinalysis, stool analysis + occult blood, blood chemistry and coagulation function), chest X-ray (AP view) or abdominal B-scan ultrasonography at screening or baseline, which are deemed clinically significant by the investigator; subjects with alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin exceeding the normal range at screening/baseline, which are deemed clinically significant by the investigator.
- Subjects who suffer from dyspepsia, esophageal reflux, peptic ulcer or gallbladder disease within 3 months prior to dosing, or any gastrointestinal disease that may affect gastric emptying, or any surgical procedure (such as cholecystectomy, except for appendicitis surgery) that may affect drug metabolism or excretion; or plan to undergo surgery during the study.
- Subjects who used any prescription drugs, OTC drugs, Chinese herbal medicines, food supplements (including vitamins, health food, etc.) within 14 days before dosing, or have other non-drug therapeutic factors affecting drug absorption, distribution, metabolism and excretion.
- ubjects who have received any other investigational drug or participated in any other interventional clinical study within 3 months prior to screening, or still within 5 half-lives of a previously administered investigational drug at screening, whichever is longer.
- Difficulty in blood collection or intolerance to venipuncture for blood collection.
- Subjects who smoked > 5 cigarettes/day on average (or used an equivalent amount of nicotine products) in 6 months prior to screening, or are unwilling to abstain from tobacco products during the study.
- Those who are not eligible for the study for other reasons as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mass Balance Study of [14C] GZR18 in Chinese Overweight or Obese Male Subjects
This trial is a Single-center, non-randomized, open-label, single-dose Mass Balance Study.
The study period of each subject consists of a screening period (D-21 to D-2), a baseline period (D-2 to D-1), a dosing and routine collection period (D1 to D36) and an intermittent collection and follow-up period (D36 to D78, during which subjects should visit the hospital once a week, 6 visits in total).
- Conditions
- Overweight, Obese, Obesity
- Being tested
- GZR18 injection、[14C]GZR18 injection
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZR18 injection、[14C]GZR18 injectionDrug
Participants will get a single dose of [14C]GZR18 injection
| Study group | Role | What they receive |
|---|---|---|
| GZR18 injection、[14C]GZR18 injection | Experimental | Not described Receives: Drug: GZR18 injection、[14C]GZR18 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
The total radioactivity recovery at each interval and the cumulative total radioactivity recovery in excreta (urine and feces).
Measured: Through study completion, an average of 1 year
Primary Outcome Measure
Percentage of parent drug and its metabolites (if applicable) in plasma in total radioactivity exposure in plasma; percentage of parent drug and its metabolites (if applicable) in urine and feces in administered dose; identification of major metabolites in plasma, urine, and feces.
Measured: Through study completion, an average of 1 year
Primary Outcome Measure
Peak Plasma Concentration (Cmax)
Measured: Through study completion, an average of 1 year
Primary Outcome Measure
Area under the plasma concentration versus time curve (AUC)
Measured: Through study completion, an average of 1 year
Primary Outcome Measure
Ratio of total radioactivity concentration in whole blood to plasma
Measured: Through study completion, an average of 1 year
Primary Outcome Measure
Time-To-Peak(Tmax)
Measured: Through study completion, an average of 1 year
Primary Outcome Measure
Mean Residence Time
Measured: Through study completion, an average of 1 year
Primary Outcome Measure
Half-Life Period（T1/2）
Measured: Through study completion, an average of 1 year
Secondary outcomes (7)
PK parameters of GZR18 and its metabolites (if applicable) in plasma
Peak Plasma Concentration (Cmax)
Measured: Through study completion, an average of 1 year
Safety Evaluation:Clinical safety evaluation during the study
weight and height will be combined to report BMI in kg/m^2
Measured: Average of 1 year
PK parameters of GZR18 and its metabolites (if applicable) in plasma
Area under the plasma concentration versus time curve (AUC)
Measured: Through study completion, an average of 1 year
PK parameters of GZR18 and its metabolites (if applicable) in plasma
Time-To-Peak(Tmax)
Measured: through study completion, an average of 1 year
PK parameters of GZR18 and its metabolites (if applicable) in plasma
Mean Residence Time
Measured: through study completion, an average of 1 year
PK parameters of GZR18 and its metabolites (if applicable) in plasma
Half-Life Period（T1/2）
Measured: through study completion, an average of 1 year
Safety Evaluation:Clinical safety evaluation during the study
laboratory tests (hematology, urinalysis, blood chemistry, coagulation function, stool analysis + occult blood and thyroid function)
Measured: Average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start7 May 2025
- Primary completion13 Aug 2025
- Study completion13 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Gan & Lee Pharmaceuticals.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gan & Lee Pharmaceuticals.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119450
- Sponsor's protocol ID
- GZR18-BWM-105
- Status last verified
- Oct 2025
- First submitted
- 9 Jul 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 Mass Balance Study of [14C] GZR18 in Chinese Overweight or Obese Male Subjects
- ClinicalTrials.gov ID
- NCT07119450
- Acronym / sponsor ID
- GZR18-BWM-105
- Conditions
- Overweight, Obese, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Gan & Lee Pharmaceuticals.Industry (pharma, biotech, devices)
- Study start
- 7 May 2025 (actual)
- Primary completion
- 13 Aug 2025 (actual)
- Study completion
- 13 Aug 2025 (actual)
- First posted
- 13 Aug 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 is a Single-center, non-randomized, open-label, single-dose Mass Balance Study.
The study period of each subject consists of a screening period (D-21 to D-2), a baseline period (D-2 to D-1), a dosing and routine collection period (D1 to D36) and an intermittent collection and follow-up period (D36 to D78, during which subjects should visit the hospital once a week, 6 visits in total).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GZR18 injection、[14C]GZR18 injection | Experimental | Drug: GZR18 injection、[14C]GZR18 injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects must be fully informed, know and understand the content, process and possible treatment-related adverse events (TRAEs) before the study, and voluntarily sign a written informed consent form;
- Chinese adult male subjects aged 18-55 (inclusive);
- Body weight ≥ 50 kg;
- Subjects with stable physical activity and lifestyle and relatively stable weight within 3 months prior to screening (as per inquiry);
- Subjects have no sperm donation plan within 6 months after the last dose, and subjects and their partners have no pregnancy plan throughout the study and within 6 months after the last dose and voluntarily take effective contraceptive measures to avoid pregnancy of their partners.
Key exclusion criteria (8 listed)
- Subjects with other clinically significant diseases or medical history that may hinder the subject from following the study protocol and completing this study as judged by the investigator.
- Subjects with abnormalities in vital signs, physical examination, routine laboratory tests (hematology, urinalysis, stool analysis + occult blood, blood chemistry and coagulation function), chest X-ray (AP view) or abdominal B-scan ultrasonography at screening or baseline, which are deemed clinically significant by the investigator; subjects with alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin exceeding the normal range at screening/baseline, which are deemed clinically significant by the investigator.
- Subjects who suffer from dyspepsia, esophageal reflux, peptic ulcer or gallbladder disease within 3 months prior to dosing, or any gastrointestinal disease that may affect gastric emptying, or any surgical procedure (such as cholecystectomy, except for appendicitis surgery) that may affect drug metabolism or excretion; or plan to undergo surgery during the study.
- Subjects who used any prescription drugs, OTC drugs, Chinese herbal medicines, food supplements (including vitamins, health food, etc.) within 14 days before dosing, or have other non-drug therapeutic factors affecting drug absorption, distribution, metabolism and excretion.
- ubjects who have received any other investigational drug or participated in any other interventional clinical study within 3 months prior to screening, or still within 5 half-lives of a previously administered investigational drug at screening, whichever is longer.
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 |
|---|---|---|
| GZR18 injection、[14C]GZR18 injectionParticipants will get a single dose of [14C]GZR18 injection | Drug | GZR18 injection、[14C]GZR18 injection |
Primary outcome
Primary Outcome Measure
Time frame: Through study completion, an average of 1 year
The total radioactivity recovery at each interval and the cumulative total radioactivity recovery in excreta (urine and feces).
Primary Outcome Measure
Time frame: Through study completion, an average of 1 year
Percentage of parent drug and its metabolites (if applicable) in plasma in total radioactivity exposure in plasma; percentage of parent drug and its metabolites (if applicable) in urine and feces in administered dose; identification of major metabolites in plasma, urine, and feces.
Primary Outcome Measure
Time frame: Through study completion, an average of 1 year
Peak Plasma Concentration (Cmax)
Primary Outcome Measure
Time frame: Through study completion, an average of 1 year
Area under the plasma concentration versus time curve (AUC)
Primary Outcome Measure
Time frame: Through study completion, an average of 1 year
Ratio of total radioactivity concentration in whole blood to plasma
Primary Outcome Measure
Time frame: Through study completion, an average of 1 year
Time-To-Peak(Tmax)
Primary Outcome Measure
Time frame: Through study completion, an average of 1 year
Mean Residence Time
Primary Outcome Measure
Time frame: Through study completion, an average of 1 year
Half-Life Period（T1/2）
7 secondary outcomes
PK parameters of GZR18 and its metabolites (if applicable) in plasma
Time frame: Through study completion, an average of 1 year
Safety Evaluation:Clinical safety evaluation during the study
Time frame: Average of 1 year
PK parameters of GZR18 and its metabolites (if applicable) in plasma
Time frame: Through study completion, an average of 1 year
PK parameters of GZR18 and its metabolites (if applicable) in plasma
Time frame: through study completion, an average of 1 year
PK parameters of GZR18 and its metabolites (if applicable) in plasma
Time frame: through study completion, an average of 1 year
PK parameters of GZR18 and its metabolites (if applicable) in plasma
Time frame: through study completion, an average of 1 year
Safety Evaluation:Clinical safety evaluation during the study
Time frame: Average of 1 year
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 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. 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 GZR18 injection、[14C]GZR18 injection in people with Overweight and Obese, run by Gan & Lee Pharmaceuticals. 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 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 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 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?
Primary Outcome Measure (time frame: Through study completion, an average of 1 year). The study lists 8 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 21 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.