The aim of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS9531 injection compared with placebo in adolescents with obesity
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Drug: HRS9531 injection; low dose Drug: Placebo
Drug: HRS9531 injection; medium dose Drug: Placebo
Drug: HRS9531 injection; high dose Drug: Placebo
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGAdverse Events (AEs)
Time frame: up to Week 28
Maximum concentration (Cmax) of HRS9531
Time frame: up to Week 28
Trough concentration (Ctrough) of HRS9531
Time frame: up to Week 28
Area under the curve from time zero to end of dosing interval (AUC0-tau)
Time frame: up to Week 28
Changes from baseline in BMI
Time frame: up to Week 24
Change from baseline in body weight
Time frame: up to Week 24
Change from baseline in waist circumference
Time frame: up to Week 24
Anti-HRS9531 antibodies (ADA)
Time frame: up to Week 28
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