Obesity, Overweight
Conditions
Brief summary
The study was a multicenter, randomized, double-blind, placebo-controlled phase Ib/IIa clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of GZR18 injection in Chinese adult obese/overweight patients. This study is divided into Part A and Part B, which are to be conducted simultaneously.
Interventions
DRUGGZR18
0.6 mg-30 mg
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 65 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Male or female aged 18-65 years (inclusive); 2\. Obese subjects: BMI ≥ 28.0 kg/m2; or overweight subjects: 24.0 ≤ BMI \< 28.0 kg/m2 with at least one comorbidity; 3\. Able to understand the procedures and methods in this study; willing to complete the study in strict accordance with the clinical study protocol and sign the ICF voluntarily.
Exclusion criteria
* 1\. Suspicion that the subject may be allergic to any study drug or ingredient or congener from the investigator. 2\. Subjects with body weight change \> 5.0% for any reason (diet, exercise, etc.) within 12 weeks prior to screening. 3\. Heart rate \< 50 beats/min or \> 100 beats/min on 12-lead ECG at screening. 4\. Presence of the following clinically significant 12-lead ECG abnormalities at screening. 5\. Alcohol abuse within 6 months prior to screening, or reluctance to stop alcohol abuse throughout the study, or a positive breath alcohol test result at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events and serious adverse events | 38 weeks |
| Changes in weight from baseline to the end of treatment | 35 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Percentage of reduction in weight (%) from baseline to the end of treatment | 35 weeks |
| trough concentrations following consecutive doses | 35 weeks |
| Proportion of subjects with ≥5% reduction in body weight from baseline. | 35 weeks |
| Changes in Waist circumference from baseline to the end of treatment | 35 weeks |
| Changes in Body mass index (BMI) from baseline to the end of treatment | 35 weeks |
Countries
China
Outcome results
None listed