CTRI/2021/06/034501进行中（未招募）3 期
Effect and safety of liraglutide 3.0 mg on weight management in children with obesity aged 6 to12 years: 56-week, double-blind, randomised, placebo-controlled trial
ovo Nordisk India Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Informed consent of parents or LAR 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
- •a The parents or LAR of the child must sign and date the Informed Consent Form according to local requirements
- •b The child must sign and date the Child Assent Form or provide oral assent according to local requirements
- •2.Male or female,aged 6 to <12 years at the time of signing informed consent
- •3.Tanner stage 1-5 pubertal development at the time of signing informed consent
- •4.BMI =95th percentile
- •5.History of failing to lose sufficient weight with lifestyle modification as judged by the
- •investigator
- •For subjects with T2D at screening the following inclusion criteria apply in addition to criteria 1-5:
- •6.Subject with T2D treated with either diet and exercise alone or stable treatment with metformin
- •for at least 90 days prior to screening
- •7.HbA1c =10.0% (86 mmol/mol) as measured by central laboratory at screening
排除标准
- •Obesity related
- •1.A self-reported or by parents or LAR where applicable change in body weight >5 kg 11 lbs
- •within 90 days before screening irrespective of medical records
- •2.Treatment with any medication for the indication of obesity within the past 90 days before
- •3.Uncontrolled thyroid disease at screening, in the opinion of the investigator
- •4.Subjects with secondary causes of obesity for example hypothalamic, monogenic or endocrine
- •Mental health
- •5.History of major depressive disorder within 2 years before screening
- •6.Diagnosis of other severe psychiatric disorders e.g., schizophrenia, bipolar disorder
- •7.A lifetime history of suicidal attempt
- •8.Subjects with confirmed diagnosis of bulimia nervosa disorder
- •General Safety
- •9.History or presence of pancreatitis acute or chronic
- •10.Calcitonin =50 ng/L
- •11.Personal or first degree relatives history of multiple endocrine neoplasia type 2 or medullary
- •thyroid carcinoma
- •12.Type 1 diabetes
- •13.Impaired renal function defined as serum-creatinine >UNR for age in children unless renal
- •function is proven normal by further assessments at the discretion of the investigator
- •14.History of malignant neoplasms within the past 5 years prior to the day of screening
- •15.Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator
- •16.Known or suspected abuse of alcohol or recreational drugs
- •17.Known or suspected hypersensitivity to trial products or related products
- •18.Previous participation in this trial. Participation is defined as signed informed consent
- •19.Participation in any clinical trial of an approved or non-approved investigational medicinal
- •product within 90 days before screening
- •20.Other subjects from the same household participating in any liraglutide trial
- •21.Female who is of child-bearing potential and not using an adequate contraceptive method
- •adequate contraceptive measure as required by local regulation or practice
- •22.Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria,
- •which in the investigator’s opinion, might jeopardise the subject’s safety or compliance with the protocol
- •Glycaemia-related
- •23.Treatment with glucose-lowering agents within 90 days before screening except for
- •24.Treatment with a GLP-1 receptor agonist within 180 days before screening
研究者
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