This is a Phase Ib, randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Efsubaglutide Alfa Injection following multiple-dose administration in Chinese adolescent participants with obesity.
The prevalence of obesity in adolescents is rising and threatening physiological and psychological health. Different from adults with obesity, there is still no approved drug to manage the obesity in adolescents, In order to provide the therapeutical option earlier, the weight-reduction study in obese adolescents is planned. The primary objective of this Phase Ib study is to evaluate the safety, tolerability, and pharmacokinetic (PK) characteristics of multiple doses of Efsubaglutide Alfa at different dose levels in Chinese adolescent participants with obesity. The secondary objectives include the evaluations of the pharmacodynamic (PD) effects, PK-PD relationship , and immunogenicity of multiple doses of Efsubaglutide Alfa at different dose levels. This randomized, double-blind, placebo-controlled, parallel-group study will enroll a total of 36 adolescent participants aged 12 to 17 years with obesity . 36 participants will be randomized in a 3:1 ratio to receive Efsubaglutide Alfa or placebo administered subcutaneously once weekly (QW) for up to 12 weeks. Safety will be monitored throughout the study by assessment of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESI), laboratory parameters, vital signs, and 12-lead electrocardiograms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
Efsubaglutide Alfa Injection Subcutaneous injection
Efsubaglutide Alfa Injection Subcutaneous injection
Efsubaglutide Alfa Injection Subcutaneous injection
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGWuhan Central Hospital
Wuhan, Hubei, China
NOT_YET_RECRUITINGShengjing Hospital, China Medical University
Shenyang, Liaoning, China
Safety and tolerability: incidence of TEAEs, SAEs, and AESI
Safety and tolerability assessed by monitoring treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESI) throughout the study
Time frame: Throughout the study (up to Week 18)
Pharmacokinetic (PK) characteristics at steady state following multiple doses
PK parameters including plasma drug concentrations at steady state following multiple-dose administration of Efsubaglutide Alfa
Time frame: Throughout the study (up to Week 18)
Change in body mass index (BMI) from baseline (absolute and percentage)
Change in BMI from baseline at Week 12, measured as absolute value and percentage change
Time frame: Week 12
Change in BMI from baseline over time (absolute and percentage)
Change in BMI from baseline at Weeks 4, 8, and 12, measured as absolute value and percentage change
Time frame: Weeks 4, 8, and 12
Change in fasting body weight from baseline (absolute and percentage)
Change in fasting body weight from baseline at Week 12, measured as absolute value and percentage change
Time frame: Week 12
Change in fasting body weight from baseline over time (absolute and percentage)
Change in fasting body weight from baseline at Weeks 4, 8, and 12, measured as absolute value and percentage change
Time frame: Weeks 4, 8, and 12
Change in waist circumference from baseline
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Efsubaglutide Alfa placebo Injection Subcutaneous injection
Qilu Hospital, Shandong University
Jinan, Shandong, China
NOT_YET_RECRUITINGQilu Second Hospital, Shandong University
Jinan, Shandong, China
RECRUITINGChange in waist circumference from baseline at Week 12
Time frame: Week 12
Change in hip circumference from baseline
Change in hip circumference from baseline at Week 12
Time frame: Week 12
Change in waist-to-hip ratio (WHR) from baseline
Change in waist-to-hip ratio (WHR) from baseline at Week 12
Time frame: Week 12
Change in waist-to-height ratio from baseline
Change in waist-to-height ratio from baseline at Week 12
Time frame: Week 12
Proportion of participants achieving ≥5%, ≥10%, and ≥15% reduction in BMI and/or fasting body weight from baseline
Time frame: Week 12
Change in systolic blood pressure and diastolic blood pressure from baseline
Time frame: Week 12
Change in lipid levels(TC、HDL-C、LDL-C、TG) from baseline
Time frame: Week 12
Change in fasting blood glucose from baseline
Time frame: Week 12
Change in HbA1c from baseline
Time frame: Week 12
Change in fasting insulin from baseline
Time frame: Week 12
Change in blood uric acid from baseline
Time frame: Week 12
The correlation between Efsubaglutide Alfa Cmax, ss and BMI
Time frame: Throughout the study (up to Week 18)
The correlation between Efsubaglutide Alfa AUC0-168h, ss and BMI
Time frame: Throughout the study (up to Week 18)
Incidence, titer, and persistence of anti-drug antibodies (ADA)
Time frame: Throughout the study (up to Week 18)
Incidence, titer, and persistence of neutralizing antibodies
Time frame: Throughout the study (up to Week 18)