A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Obese/Overweight Subjects

Gan & Lee Pharmaceuticals.1 site in 1 country630 target enrollmentDecember 30, 2024

ConditionsObesity/Overweight

InterventionsGZR18 Placebo

DrugsGZR18

Overview

Phase: Phase 3
Intervention: GZR18
Conditions: Obesity/Overweight
Sponsor: Gan & Lee Pharmaceuticals.
Enrollment: 630
Locations: 1
Primary Endpoint: Percent change in weight from baseline (%)
Status: Active, not recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study in adult obese/overweight subjects in China to evaluate the efficacy and safety of GZR18 Injection in the subjects.

Registry

clinicaltrials.gov

Start Date

December 30, 2024

End Date

May 1, 2026

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Gan & Lee Pharmaceuticals.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years (as of the date of signing the Informed Consent Form (ICF)), male or female.
•Obese (BMI ≥ 28 kg/m2) or overweight (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.
•Subjects of childbearing potential with no birth plan from the signing of ICF to 8 weeks after the last dose, willingness to take effective contraceptive measures, and no plan for sperm donation. Females of childbearing potential must not be lactating and must have negative results of pregnancy tests at screening and Visit 2 (before randomization).

Exclusion Criteria

•Known or suspected hypersensitivity to glucagon like peptide-1 receptor agonist (GLP-1RA) drugs or excipients.
•History of drug abuse prior to screening.
•History of alcohol abuse within 6 months before screening.
•Weight change of \> 5.0% within 3 months before screening (self-report).
•Presence of limb deformity or mutilation affecting height measurement.

Arms & Interventions

GZR18

Intervention: GZR18

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Percent change in weight from baseline (%)

Time Frame: From Week 0 to Week 48

Secondary Outcomes

Proportion of subjects with ≥ 10%, 15%, 20%, and 25% decrease in weight from baseline(From Week 0 to Week 48)
Changes from baseline in weight(From Week 0 to Week 48)
Changes from baseline in body mass index (BMI)(From Week 0 to Week 48)
Changes from baseline in hip circumference(From Week 0 to Week 48)
Changes from baseline in waist circumference(From Week 0 to Week 48)
Changes from baseline in waist-hip ratio (waist circumference/hip circumference)(From Week 0 to Week 48)
Treatment emergent adverse events (TEAEs)(From Week 0 to Week 48)