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COMPLETEDPHASE1

A Phase I Study of GZR18 Injection in Obese/Overweight Subjects

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

NCT06548945•Gan and Lee Pharmaceuticals, USA

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Locations (1)

Gan & Lee Pharmaceuticals Co., Ltd

Beijing, China

Key Dates

Start Date

April 25, 2023

Primary Completion Date

August 14, 2023

Completion Date

August 14, 2023

Last Updated

August 14, 2024

Enrollment

ACTUAL participants

Conditions

Overweight and Obesity

Interventions

GZR18

DRUG

Placebo

OTHER

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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: August 14, 2024Data 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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A Phase I Study of GZR18 Injection in Obese/Overweight Subjects

Inclusion Criteria

Exclusion Criteria

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