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

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Other: Placebo; Drug: GZR18

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Gan & Lee Pharmaceuticals Co., Ltd

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; administered the same volume as GZR18
Experimental: GZR18	Drug: GZR18; 5 mg-maximum tolerated dose (MTD), single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TEAE	Incidence of Treatment Emergent Adverse Event(s)	50 days
Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab)		50 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum plasma drug concentration	50 days
AUClast	area under the curve from 0 through the time of the last accurately measurable concentration	50 days
AUC0-inf	area under the curve extrapolated to infinity	50 days
Tmax	time to maximum plasma drug concentration	50 days
λz	elimination rate constant	50 days
t1/2	half-life	50 days
tlag	lag time	50 days
CL/F	apparent clearance	50 days
Vz/F	volume of distribution/F	50 days
AUC%extra	percent of AUC0-inf extrapolated	50 days
MRT	mean residence time	50 days
Weight		50 days
Body Mass Index (BMI)		50 days

Collaborators and Investigators

• Sponsor: Gan and Lee Pharmaceuticals, USA
• Investigators: Study Director: Liyuan Zhao, Ph.D, Gan & Lee Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Actual): August 14, 2023
• Study Completion (Actual): August 14, 2023

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: GL-GLP-CH1017

Drug and device information, study documents

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