Obesity, Overweight
Conditions
Brief summary
This study is a multicenter, randomized, placebo-controlled phase II clinical study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of GZR18 injection in Chinese adult obese/overweight subjects.
Interventions
DRUGGZR18
Titrated to dose 1, dose 2, dose 3 or dose 4
OTHERPlacebo
Administered the same volume as GZR18
Sponsors
Gan and Lee Pharmaceuticals, USA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria: 1. Male or female aged 18-75 years (inclusive). 2. Obese subjects (BMI≥28 kg/m2), Or overweight subjects (24 kg/m2≤BMI\<28 kg/m2) with at least one comorbidity. 3. 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. *
Exclusion criteria
1. Limb deformities or defects affecting height and body weight measurement. 2. Pregnant or lactating women, men or women of reproductive potential unwilling to use contraception throughout the study and for 6 months after the last dose of investigational drug. 3. History of drug abuse within 1 year before screening, or positive results in drug abuse screening during screening or before randomization. 4. Alcohol abuse history within 6 months prior to screening. 5. Subjects who are known or suspected to be allergic to GLP-1 drugs or excipients. 6. Subjects with an absolute weight change greater than 5.0% due to any reason within the 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent (%) change from baseline in body weight at the end of the study (W30) | 30 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight, waist circumference, waist-to-hip ratio (waist circumference/hip circumference), and body mass index (BMI) | 30 weeks | Changes from baseline |
| Percentage (%) of weight | 33 weeks | Change from baseline at the last safety follow-up visit (W33) after discontinuation |
| Glucose metabolism indicators: glycated hemoglobin A1C (HbA1c), fasting plasma glucose (FPG), fasting insulin, insulin resistance index (HOMA-IR), and islet β cell function (HOMA-β) | 30 weeks | Changes from baseline |
| Cardiovascular disease risk factors: blood pressure (SBP and DBP), pulse, total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), and triglycerides (TG) | 30 weeks | Changes from baseline |
| Patient-reported weight-related quality of life scores: IWQoL-Lite-CT and SF-36 scale | 30 weeks | Changes from baseline |
| Proportion of subjects who achieved (yes/no) body weight reduction ≥5%, 10%, 15%, 20% from baseline. | 30 weeks | — |
| AUClast, AUC0-inf, Tmax, λz, t1/2, tlag, CL/F, Vz/F, AUC%extra, MRT, Css_min, Css_max, Css_av, DF, Css_min | 30 weeks | — |
| The number of adverse events (AEs)/serious adverse events (SAEs) /AEs of special interest (AESIs) that occurred during the study. | 33 weeks | — |
| Vital signs, physical examination, 12-lead Electrocardiogram (ECG), and clinical laboratory tests (hematology, urinalysis, blood biochemistry, blood amylase, blood lipase, coagulation function, calcitonin,TSH/FT3/FT4 | 33 weeks | Change from baseline |
| Subject's mental health status (assessed by using the Columbia-Suicide Severity Rating Scale and Patient Health Questionnaire (PHQ-9)) | 33 weeks | — |
| Anti-drug antibodies (ADAs) for GZR18 and neutralizing antibodies (NAbs) following GZR18 Injection | 33 weeks | Changes from baseline |
Countries
China
Outcome results
None listed