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
Qualifiers
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
Treatments tested in this trial
- Efsubaglutide Alfa 5 mg QW
- Efsubaglutide Alfa 10 mg QW
- Efsubaglutide Alfa 20 mg QW
- Efsubaglutide Alfa placebo
Treatment groups
36 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov