To evaluate the efficacy and dose-response relationship of HRS9531 injection compared with placebo in reducing body weight in obese subjects without diabetes after 24 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
249
HRS9531 injection: dose level 1 for 32 weeks、level 2 for 20 weeks
HRS9531 injection: dose level 2
HRS9531 injection: dose level 3
Percentage change in body weight
Percentage Change from baseline in body weight after 24 weeks of treatment
Time frame: Week 0, Week 24
Proportion of subjects with weight loss of ≥5% from baseline in body weight after 24 weeks of treatment
Time frame: Week 24
Proportion of subjects with weight loss of ≥10% from baseline in body weight after 24 weeks of treatment
Time frame: Week 24
Change from baseline in body weight after 24 weeks of treatment
Time frame: Week 0, Week 24
Change from baseline in waist circumference after 24 weeks of treatment
Time frame: Week 0, Week 24
Change from baseline in BMI after 24 weeks of treatment
Time frame: Week 0, Week 24
Change from baseline in blood pressure after 24 weeks of treatment
Time frame: Week 0, Week 24
Change from baseline in total cholesterol after 24 weeks of treatment
Time frame: Week 0, Week 24
Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment
Time frame: Week 0, Week 24
Change from baseline in glycosylated haemoglobin (HbA1c) after 24 weeks of treatment
Time frame: Week 0, Week 24
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HRS9531 injection: dose level 4
Placebo arm matching active arm HRS9531 injection dose level 1 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Placebo arm matching active arm HRS9531 injection dose level 2 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Placebo arm matching active arm HRS9531 injection dose level 3 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Placebo arm matching active arm HRS9531 injection dose level 4 for 32 weeks、HRS9531 injection level 2 for 20 weeks
The second affiliated hospital of Anhui medical university
Hefei, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Huadu District People's Hospital of Guangzhou
Guangzhou, Guangdong, China
The people's hospital of Longhua.Shenzhen
Shenzhen, Guangdong, China
Department of Endocrinology,Sencond Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology
Luoyang, Henan, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China
...and 16 more locations
Number of AEs During the Trial
Time frame: Week 0 to Week 56
Percentage change in body weight
Time frame: Week 0, Week 32
Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 32 weeks of treatment
Time frame: Week 32
Proportion of Subjects with weight loss of ≥10% from baseline in body weight after 32 weeks of treatment
Time frame: Week 32
Change from baseline in body weight after 32 weeks of treatment
Time frame: Week 0, Week 32
Change from baseline in waist circumference after 32 weeks of treatment
Time frame: Week 0, Week 32
Change from baseline in BMI after 32 weeks of treatment
Time frame: Week 0, Week 32
Change from baseline in blood pressure after 32 weeks of treatment
Time frame: Week 0, Week 32
Change from baseline in total cholesterol after 32 weeks of treatment
Time frame: Week 0, Week 32
Change from baseline in fasting plasma glucose (FPG) after 32 weeks of treatment
Time frame: Week 0, Week 32
Change from baseline in glycosylated haemoglobin (HbA1c) after 32 weeks of treatment
Time frame: Week 0, Week 32