Phase Ib Study of Efsubaglutide Alfa Injection in Obese Adolescents
ConditionAdolescence Obesity
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12-17
SponsorShanghai Yinnuo Pharmaceutical Technology Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Informed consent must be obtained from the participant's parent or legally authorized representative and assent from the adolescent participant before any study-related procedures.
2. Adolescent participants aged ≥12 years and <18 years (at the time of informed consent).
3. At screening, meet the obesity criteria defined in "WS/T586-2018 Screening for Overweight and Obesity among School-age Children and Adolescents".
4. Before screening, have been on dietary and exercise control alone for at least 3 months with <5.0% reduction in body mass index (based on self-report or report by parent or legally authorized representative).
Disqualifiers
1. Pre-pubertal participants (Tanner Stage I).
2. History of severe allergic reactions or suspected allergy to study drug or its ingredients.
3. Pregnant or lactating women; men or women of childbearing potential planning pregnancy or unwilling to use highly effective contraception throughout the study.
4. Use of weight-affecting medications before screening.
Trial design
Design model
Parallel
Treatments tested in this trial
Efsubaglutide Alfa 5 mg QW
DrugEfsubaglutide Alfa Injection Subcutaneous injection
Efsubaglutide Alfa 10 mg QW
DrugEfsubaglutide Alfa Injection Subcutaneous injection
Efsubaglutide Alfa 20 mg QW
DrugEfsubaglutide Alfa Injection Subcutaneous injection
Efsubaglutide Alfa placebo
DrugEfsubaglutide Alfa placebo Injection Subcutaneous injection
Treatment groups
36 Participants
are divided into 4 treatment groupsGroup A: Efsubaglutide Alfa 5 mg QWExperimental treatment 1 intervention
Group B: Efsubaglutide Alfa 10 mg QWExperimental treatment 1 intervention
Group C: Efsubaglutide Alfa 20 mg QWExperimental treatment 1 intervention
Group D: Efsubaglutide Alfa placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)Secondary outcomes
1
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 122
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 123
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 124
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 12Sponsors and contacts
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Source ClinicalTrials.gov