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

Gan & Lee Pharmaceuticals.

Status and phase

Active, not recruiting

Phase 3

Conditions

Obesity/Overweight

Treatments

Other: Placebo

Drug: GZR18

Study type

Interventional

Funder types

Industry

Identifiers

NCT06728124

GZR18-BWM-301

Details and patient eligibility

About

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.

Enrollment

630 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.