The Study of [14C] GZR18

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

NCT07119450•Gan & Lee Pharmaceuticals.

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, during which subjects should visit the hospital once a week, 6 visits in total).

Eligibility

Age

18 - 55 years

Sex

MALE

Healthy Volunteers

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.

Locations (1)

Study site 01

Beijing, China

Key Dates

Start Date

May 7, 2025

Primary Completion Date

August 13, 2025

Completion Date

August 13, 2025

Last Updated

November 21, 2025

Enrollment

ACTUAL participants

Conditions

OverweightObeseObesity

Interventions

GZR18 injection、[14C]GZR18 injection

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Study of [14C] GZR18

Inclusion Criteria

Exclusion Criteria

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