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Active, not recruiting Phase 3

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

NCT06728124 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2024-12-30
Last updated
2025-11-25

Condition(s) studied

Obesity/Overweight

Investigational drug(s) / intervention(s)

GZR18 →Placebo

GZR18: Used as specified in the protocol

Placebo: Administered the same volume as GZR18

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Percent change in weight from baseline (%) — From Week 0 to Week 48

Trial sites (1)

FacilityCityRegionStatus
Beijing Beijing China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06728124 on ClinicalTrials.gov ↗ ← All trials in China