The aim of the study is to evaluate the safety and efficacy of Ecnoglutide injection in overweight or obese Chinese adolescents
In this study, eligible participants will be randomized into one of the three cohorts in a 3:1 ratio to receive either once-weekly subcutaneous Ecnoglutide injection or placebo, for up to 52 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
192
Subcutaneous injection
Subcutaneous injection
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Percent change in Body Mass Index (BMI)
Time frame: Baseline, week 40
Percentage of participants with ≥5% of BMI reduction
Time frame: Baseline, week 40 and week 52
Change in BMI
Include percent change and absolute change
Time frame: Baseline, week 52
Percentage of participants with ≥10% of BMI reduction
Time frame: Baseline, week 52
Percentage of participants with ≥15% of BMI reduction
Time frame: Baseline, week 52
Percentage of participants with ≥20% of BMI reduction
Time frame: Baseline, week 52
Change in body weight
Include percent change and absolute change
Time frame: Baseline, week 52
Change in Glycated Hemoglobin (HbA1c)
Time frame: Baseline, week 52
Change in Fasting Plasma Glucose (FPG)
Time frame: Baseline, week 52
Change in Fasting Insulin
Time frame: Baseline, week 52
Change in Homeostasis Model Assessment 2 - Insulin Resistance (HOMA2-IR)
Time frame: Baseline, week 52
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Change in Homeostasis Model Assessment 2 - Beta Cell Function (HOMA2-β)
Time frame: Baseline, week 52
Change in lipid profile
Include triglycerides, LDL-C, HDL-C, total cholesterol
Time frame: Baseline, week 52
Change in liver enzymes
Include alanine aminotransferase, aspartate aminotransferase and gamma-glutamyl transferase
Time frame: Baseline, week 52
Adverse events
Incidence and severity
Time frame: From week1 to week 57
Trough concentration of ecnoglutide
Time frame: From baseline to week 57 (EOS)