Effect and safety of liraglutide 3.0 mg on weight management in children with obesity aged 6 to <12 years: 56-week, double-blind, randomised, placebo-controlled trial

ovo Nordisk A/S0 个研究点目标入组 78 人开始时间: 2020年11月26日最近更新: 2024年2月26日

适应症

试验速览

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•- Informed consent of parent(s) or legally acceptable representative of subject and child assent, as age-appropriate, obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
•- Male or female, aged 6 to below 12 years at the time of signing informed consent
•- Tanner stage 1-5 pubertal development at the time of signing informed consent
•- Body Mass Index (BMI) greater than or equal to 95th percentile, on gender and age-specific growth charts (CDC.gov)
•- History of failing to lose sufficient weight with lifestyle modification as judged by the investigator
•- For subjects with type 2 diabetes at screening the following inclusion criterion apply in addition:
•Haemoglobin A1c (glycated haemoglobin (HbA1c)) less than or equal to 10.0% (86 mmol/mol) as measured by central laboratory at screening
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 78
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- A self-reported (or by parent(s)/legally acceptable representative (LAR) where applicable) change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
•- Treatment with any medication for the indication of obesity within the past 90 days before screening
•- Type 1 diabetes
•- Subjects with secondary causes of obesity (for example hypothalamic, monogenic or endocrine causes)

发起方