A Multicenter, Randomized, Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Obese/Overweight Patients

Gan and Lee Pharmaceuticals, USA1 site in 1 country340 target enrollmentJune 8, 2023

ConditionsObesity Overweight

InterventionsGZR18 Placebo

DrugsGZR18

Overview

Phase: Phase 2
Intervention: GZR18
Conditions: Obesity
Sponsor: Gan and Lee Pharmaceuticals, USA
Enrollment: 340
Locations: 1
Primary Endpoint: Percent (%) change from baseline in body weight at the end of the study (W30)
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a multicenter, randomized, placebo-controlled phase II clinical study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of GZR18 injection in Chinese adult obese/overweight subjects.

Registry

clinicaltrials.gov

Start Date

June 8, 2023

End Date

June 5, 2024

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Gan and Lee Pharmaceuticals, USA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female aged 18-75 years (inclusive).
•Obese subjects (BMI≥28 kg/m2), Or overweight subjects (24 kg/m2≤BMI\<28 kg/m2) with at least one comorbidity.
•Able to understand the procedures and methods in this study; willing and able to maintain a stable diet and exercise lifestyle during the research period, and willing to sign the ICF voluntarily.

Exclusion Criteria

•Limb deformities or defects affecting height and body weight measurement.
•Pregnant or lactating women, men or women of reproductive potential unwilling to use contraception throughout the study and for 6 months after the last dose of investigational drug.
•History of drug abuse within 1 year before screening, or positive results in drug abuse screening during screening or before randomization.
•Alcohol abuse history within 6 months prior to screening.
•Subjects who are known or suspected to be allergic to GLP-1 drugs or excipients.
•Subjects with an absolute weight change greater than 5.0% due to any reason within the 3 months prior to screening.

Arms & Interventions

GZR18

GZR18 injection s.c.

Intervention: GZR18

Placebo

Placebo injection s.c.

Intervention: Placebo

Outcomes

Primary Outcomes

Percent (%) change from baseline in body weight at the end of the study (W30)

Time Frame: 30 weeks

Secondary Outcomes

Proportion of subjects who achieved (yes/no) body weight reduction ≥5%, 10%, 15%, 20% from baseline.(30 weeks)
Weight, waist circumference, waist-to-hip ratio (waist circumference/hip circumference), and body mass index (BMI)(30 weeks)
Percentage (%) of weight(33 weeks)
Glucose metabolism indicators: glycated hemoglobin A1C (HbA1c), fasting plasma glucose (FPG), fasting insulin, insulin resistance index (HOMA-IR), and islet β cell function (HOMA-β)(30 weeks)
Cardiovascular disease risk factors: blood pressure (SBP and DBP), pulse, total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), and triglycerides (TG)(30 weeks)
Patient-reported weight-related quality of life scores: IWQoL-Lite-CT and SF-36 scale(30 weeks)
Anti-drug antibodies (ADAs) for GZR18 and neutralizing antibodies (NAbs) following GZR18 Injection(33 weeks)
AUClast, AUC0-inf, Tmax, λz, t1/2, tlag, CL/F, Vz/F, AUC%extra, MRT, Css_min, Css_max, Css_av, DF, Css_min(30 weeks)
The number of adverse events (AEs)/serious adverse events (SAEs) /AEs of special interest (AESIs) that occurred during the study.(33 weeks)
Vital signs, physical examination, 12-lead Electrocardiogram (ECG), and clinical laboratory tests (hematology, urinalysis, blood biochemistry, blood amylase, blood lipase, coagulation function, calcitonin,TSH/FT3/FT4(33 weeks)
Subject's mental health status (assessed by using the Columbia-Suicide Severity Rating Scale and Patient Health Questionnaire (PHQ-9))(33 weeks)