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CompletedPhase 1

The Study of [14C] GZR18

A Mass Balance Study of [14C] GZR18 in Chinese Overweight or Obese Male Subjects

Asset

GZR18

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

6

actual

Study population

Obesity / overweight

Key I/E criterion

Male

Primary endpoint

Primary Outcome Measure

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07119450
Org study IDGZR18-BWM-105

Timeline

Milestones

Study start2025-05-07actual
Study first posted2025-08-13actual
Primary completion2025-08-13actual
Study completion2025-08-13actual
Last update posted2025-11-21actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexMale
Healthy volunteersNot accepted

Inclusion criteria

1. 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;

2. Chinese adult male subjects aged 18-55 (inclusive);

3. Body weight ≥ 50 kg;

4. Subjects with stable physical activity and lifestyle and relatively stable weight within 3 months prior to screening (as per inquiry);

5. 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.

Exclusion criteria

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. Difficulty in blood collection or intolerance to venipuncture for blood collection.

7. 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.

8. Those who are not eligible for the study for other reasons as judged by the investigator.

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
8
Safety / tolerability / PK
7

Safety / tolerability / PK

7 endpoints
Secondary/protocol endpoint

PK parameters of GZR18 and its metabolites (if applicable) in plasma

Time frame:Through study completion, an average of 1 year

concentration, descriptive

Secondary/protocol endpoint

Safety Evaluation:Clinical safety evaluation during the study

Time frame:Average of 1 year

descriptive

Secondary/protocol endpoint

PK parameters of GZR18 and its metabolites (if applicable) in plasma

Time frame:Through study completion, an average of 1 year

concentration, descriptive

Secondary/protocol endpoint

PK parameters of GZR18 and its metabolites (if applicable) in plasma

Time frame:through study completion, an average of 1 year

concentration, descriptive

Secondary/protocol endpoint

PK parameters of GZR18 and its metabolites (if applicable) in plasma

Time frame:through study completion, an average of 1 year

concentration, descriptive

Secondary/protocol endpoint

PK parameters of GZR18 and its metabolites (if applicable) in plasma

Time frame:through study completion, an average of 1 year

concentration, descriptive

Secondary/protocol endpoint

Safety Evaluation:Clinical safety evaluation during the study

Time frame:Average of 1 year

descriptive

Other (unclassified)

8 endpoints
Primary/protocol endpoint/low confidence

Primary Outcome Measure

Time frame:Through study completion, an average of 1 year

descriptive

Primary/protocol endpoint/low confidence

Primary Outcome Measure

Time frame:Through study completion, an average of 1 year

descriptive

Primary/protocol endpoint/low confidence

Primary Outcome Measure

Time frame:Through study completion, an average of 1 year

descriptive

Primary/protocol endpoint/low confidence

Primary Outcome Measure

Time frame:Through study completion, an average of 1 year

descriptive

Primary/protocol endpoint/low confidence

Primary Outcome Measure

Time frame:Through study completion, an average of 1 year

descriptive

Primary/protocol endpoint/low confidence

Primary Outcome Measure

Time frame:Through study completion, an average of 1 year

descriptive

Primary/protocol endpoint/low confidence

Primary Outcome Measure

Time frame:Through study completion, an average of 1 year

descriptive

Primary/protocol endpoint/low confidence

Primary Outcome Measure

Time frame:Through study completion, an average of 1 year

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.