Adolescents With Obesity, Adolescents With Overweight & Weight-related Comorbidities
Conditions
Keywords
Weight management, ecnoglutide, adolescent, obesity
Brief summary
The aim of the study is to evaluate the safety and efficacy of Ecnoglutide injection in overweight or obese Chinese adolescents
Detailed description
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
Interventions
Subcutaneous injection
Subcutaneous injection
Sponsors
Hangzhou Sciwind Biosciences Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. At screening, the BMI meets the obesity criteria specified in 'WS/T586-2018 Screening for Overweight and Obesity in School-Aged Children and Adolescents', or it meets the overweight criteria and is accompanied by at least one weight-related comorbidity: hyperglycemia, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea syndrome, etc. 2. Participant with body weight loss \<5% by diet and exercise for at least 3 months before screening (per self, parental/legal report).
Exclusion criteria
1. Pre-adolescent participants (Tanner phase 1); 2. History of receiving weight loss surgery or plan to undergo weight loss surgery during the study period (excluding acupuncture-based weight loss, liposuction, or abdominal fat removal procedures conducted more than 1 year prior to screening); 3. Known secondary obesity, including but not limited to that resulting from: hypercortisolism (e.g. Cushing's syndrome), pituitary or hypothalamic lesions, or monogenic obesity, etc.; 4. Diagnosis with any type of diabetes; 5. History of acute or chronic pancreatitis, history of gallbladder disease or pancreatic injury; 6. History of using any approved or unapproved drugs for weight loss, antidiabetic drugs, long-term systemic glucocorticoids (more than 14 days), within 3 months prior to screening;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in Body Mass Index (BMI) | Baseline, week 40 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with ≥5% of BMI reduction | Baseline, week 40 and week 52 | — |
| Change in BMI | Baseline, week 52 | Include percent change and absolute change |
| Percentage of participants with ≥10% of BMI reduction | Baseline, week 52 | — |
| Percentage of participants with ≥15% of BMI reduction | Baseline, week 52 | — |
| Percentage of participants with ≥20% of BMI reduction | Baseline, week 52 | — |
| Change in body weight | Baseline, week 52 | Include percent change and absolute change |
| Change in Glycated Hemoglobin (HbA1c) | Baseline, week 52 | — |
| Change in Fasting Plasma Glucose (FPG) | Baseline, week 52 | — |
| Change in Fasting Insulin | Baseline, week 52 | — |
| Change in Homeostasis Model Assessment 2 - Insulin Resistance (HOMA2-IR) | Baseline, week 52 | — |
| Change in Homeostasis Model Assessment 2 - Beta Cell Function (HOMA2-β) | Baseline, week 52 | — |
| Change in lipid profile | Baseline, week 52 | Include triglycerides, LDL-C, HDL-C, total cholesterol |
| Change in liver enzymes | Baseline, week 52 | Include alanine aminotransferase, aspartate aminotransferase and gamma-glutamyl transferase |
| Adverse events | From week1 to week 57 | Incidence and severity |
| Trough concentration of ecnoglutide | From baseline to week 57 (EOS) | — |
Countries
China
Contacts
CONTACTYao Li
PRINCIPAL_INVESTIGATORJunfen Fu, Dr
The Children's Hospital of Zhejiang University School of Medicine
Outcome results
None listed