This study aims to evaluate the efficacy and safety of HRS9531 tablets compared with placebo in reducing body weight in overweight or obese subjects after 52 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
675
HRS9531 tablet.
HRS9531 tablet placebo.
Henan Provincial People's Hospital
Zhengzhou, Henan, China
RECRUITINGNanjing Drum Tower hospital
Nanjing, Jiangsu, China
RECRUITINGPercentage change from baseline in body weight after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Proportion of subjects with weight loss of ≥ 5% from baseline in body weight after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Proportion of subjects with weight loss of ≥ 10% from baseline in body weight after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Proportion of subjects with weight loss of ≥ 15% from baseline in body weight after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Proportion of subjects with weight loss of ≥ 20% from baseline in body weight after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Change from baseline in waist circumference after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Change from baseline in body weight after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Change from baseline in BMI (Body Mass Index) after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Change from baseline in blood pressure after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Change from baseline in fasting plasma glucose after 52 weeks of treatment
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Time frame: After 52 weeks of treatment.
Change from baseline in fasting serum insulin after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Change from baseline in glycosylated hemoglobin after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Change from baseline in blood lipid after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Change from baseline in blood uric acid after 52 weeks of treatment
Time frame: After 52 weeks of treatment.
Number of treatment serious adverse events (SAEs) within 57 weeks
Time frame: Within 57 weeks.
Number of treatment adverse events (AEs) within 57 weeks
Time frame: Within 57 weeks.