The Study of [14C] GZR18

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).

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Obese
• Intervention / Treatment: Drug: GZR18 injection、[14C]GZR18 injection

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Study site 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GZR18 injection、[14C]GZR18 injection	Drug: GZR18 injection、[14C]GZR18 injection; Participants will get a single dose of [14C]GZR18 injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome Measure	The total radioactivity recovery at each interval and the cumulative total radioactivity recovery in excreta (urine and feces).	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.	Through study completion, an average of 1 year
Primary Outcome Measure	Peak Plasma Concentration (Cmax)	Through study completion, an average of 1 year
Primary Outcome Measure	Area under the plasma concentration versus time curve (AUC)	Through study completion, an average of 1 year
Primary Outcome Measure	Ratio of total radioactivity concentration in whole blood to plasma	Through study completion, an average of 1 year
Primary Outcome Measure	Time-To-Peak(Tmax)	Through study completion, an average of 1 year
Primary Outcome Measure	Mean Residence Time	Through study completion, an average of 1 year
Primary Outcome Measure	Half-Life Period（T1/2）	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters of GZR18 and its metabolites (if applicable) in plasma	Peak Plasma Concentration (Cmax)	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	Average of 1 year
PK parameters of GZR18 and its metabolites (if applicable) in plasma	Area under the plasma concentration versus time curve (AUC)	Through study completion, an average of 1 year
PK parameters of GZR18 and its metabolites (if applicable) in plasma	Time-To-Peak(Tmax)	through study completion, an average of 1 year
PK parameters of GZR18 and its metabolites (if applicable) in plasma	Mean Residence Time	through study completion, an average of 1 year
PK parameters of GZR18 and its metabolites (if applicable) in plasma	Half-Life Period（T1/2）	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)	Average of 1 year

Collaborators and Investigators

• Sponsor: Gan & Lee Pharmaceuticals.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2025
• Primary Completion (Actual): August 13, 2025
• Study Completion (Actual): August 13, 2025

Study Registration Dates

• First Submitted: July 9, 2025
• First Submitted That Met QC Criteria: August 5, 2025
• First Posted (Actual): August 13, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: GZR18-BWM-105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No