Obesity/Overweight
Conditions
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.
Interventions
DRUGGZR18
Used as specified in the protocol
OTHERPlacebo
Administered the same volume as GZR18
Sponsors
Gan & Lee Pharmaceuticals.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in weight from baseline (%) | From Week 0 to Week 48 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Proportion of subjects with ≥ 10%, 15%, 20%, and 25% decrease in weight from baseline | 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 | — |
| Changes from baseline in waist circumference | From Week 0 to Week 48 | — |
Countries
China
Outcome results
None listed