A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Obese/Overweight Subjects

Phase 3

Not yet recruiting

• Conditions: Obesity/Overweight
• Interventions: Drug: GZR18; Other: Placebo

• Registration Number: NCT06728124
• Lead Sponsor: Gan & Lee Pharmaceuticals.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-10
• Last Update Submitted: 2024-12-10
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 630

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GZR18	GZR18	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percent change in weight from baseline (%)	From Week 0 to Week 48

Secondary Outcome Measures

Name	Time	Method
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	weight and height will be combined to report BMI in kg/m\^2
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