Clinical trial

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

Active, not recruiting · Phase 3 · 1 countries · Registry ID NCT06728124

Active, not recruitingPhase 3Interventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity/Overweight

Full registry 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.

Treatments and study arms

GZR18

Drug

Used as specified in the protocol

Placebo

Other

Administered the same volume as GZR18

Primary outcomes

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Beijing🇨🇳 Beijing, China