To evaluate the efficacy and safety of SYH2069 injection compared with placebo in obese Non-diabetic Participants after 28 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
360
0.6ml , 1.2ml , administered subcutaneously (SC),Administer the drug according to the clinical trial protocol
0.6ml , 1.2ml , SC,Administer the drug according to the clinical trial protocol
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Relative percentage change in body weight from baseline at of treatment at 28 weeks of treatment
Time frame: 28 weeks
Proportion of subjects with a weight loss of ≥5% , 10%, 15% from baseline at 28 weeks of treatment
Time frame: Baseline through Week 28
Change from baseline in body Weight
Time frame: Week 2, 4, 8, 12, 16, 20, 24 and 28
Changes from baseline in waist circumference
Time frame: Baseline through Week 28
Changes from baseline in hip circumference
Time frame: Baseline through Week 28
Changes from baseline in waist-to-hip ratio
Time frame: Baseline through Week 28
Changes from baseline in Body Mass Index (BMI)
Time frame: Baseline through Week 28
Changes from baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline through Week 28
Changes from baseline in fasting plasma glucose (FPG)
Time frame: Baseline through Week 28
Changes from baseline in fasting C-peptide
Time frame: Baseline through Week 28
Changes from baseline in Homeostatic Model Assessment of Insulin Resistance(HOMA-IRs)
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Time frame: Baseline through Week 28
Changes from baseline in systolic blood pressure
Time frame: Baseline through Week 28
Changes from baseline in diastolic blood pressure
Time frame: Baseline through Week 28
Changes from baseline in lipid parameters (TC, LDL-C, HDL-C, non-HDL-C, TG, ApoB)
Time frame: Baseline through Week 28
Changes from baseline in high sensitivity C reactive protein (hs-CRP)
Time frame: Baseline through Week 28
Changes from baseline in urinary albumin-to-creatinine ratio (UACR)
Time frame: Baseline through Week 28
The incidence rate of adverse events (AEs)
Time frame: Baseline through Week 31
Plasma concentrations & PK parameters: Peak Time (Tmax)
Time frame: Baseline through Week 31
Plasma concentrations & PK parameters: Peak Plasma Concentration (Cmax)
Time frame: Baseline through Week 31
Plasma concentrations & PK parameters: Area under the plasma concentration versus time curve(AUC) : AUClast, AUC0-168h, AUC0-336h
Time frame: Baseline through Week 31