This study is a multicenter, randomized, open-label, parallel-group phase III clinical trial comparing the efficacy and safety of GZR18 Injection and semaglutide (Wegovy®) in adult obese or overweight subjects, aiming to evaluate the efficacy and safety of GZR18 Injection in this population.
Aged ≥ 18 years old (based on the date of signing the informed consent form), male or female.
Comorbidity of one or more of the following: hyperglycemia (see Appendix 1 for definition), hypertension, dyslipidemia (see Appendix 2 for definition), or fatty liver; ②Weight-bearing joint pain;
Weight-related obstructive sleep apnea syndrome.
Prior to screening, the subject has been managed by diet and exercise alone for at least 12 weeks, and the body weight change has been < 5% within the past 12 weeks (based on self-report).
Fasting plasma glucose ≥ 7.0 mmol/L or glycated hemoglobin (HbA1c) ≥ 6.5% as measured by the central laboratory at screening.
Diagnosis of any type of diabetes (excluding gestational diabetes) prior to screening.
Use of glucagon-like peptide-1 receptor (GLP-1R) agonists or drugs with a GLP-1R agonist mechanism of action (e.g., GLP-1R/glucagon receptor (GCGR) agonists, glucose-dependent insulinotropic polypeptide receptor (GIPR)/GLP-1R agonists, or GIPR/GLP-1R/GCGR agonists, etc.) prior to screening.
Use of glucagon-like peptide-1 receptor (GLP-1R) agonists or drugs with a GLP-1R agonist mechanism of action (e.g., GLP-1R/glucagon receptor (GCGR) agonists, glucose-dependent insulinotropic polypeptide receptor (GIPR)/GLP-1R agonists, or GIPR/GLP-1R/GCGR agonists, etc.) within 180 days prior to screening; or a history of poor blood glucose control efficacy or intolerance to the above-mentioned drugs (as assessed by the investigator).
Parallel
GZR18
DrugAdministered SC
Semaglutide(Wegovy® )
DrugAdministered SC
Percentage change in body weight from baseline after 52 weeks (W) of treatment.
Efficacy Outcome Measure :Percentage of subjects with body weight reduction ≥ 5% from baseline
Efficacy Outcome Measure :Percentage of subjects with body weight reduction ≥ 10% from baseline
Efficacy Outcome Measure :Percentage of subjects with body weight reduction ≥ 15% from baseline
Efficacy Outcome Measure :Percentage of subjects with body weight reduction ≥ 20% from baseline
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