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临床试验/2022-502922-41-00
2022-502922-41-00招募中3 期

Long-term safety and efficacy of semaglutide s.c. once-weekly on weight management in children and adolescents (aged 6 to <18 years) with obesity or overweight

Novo Nordisk A/S18 个研究点 分布在 6 个国家目标入组 86 人开始时间: 2023年6月13日最近更新:
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试验速览

阶段
3 期
状态
招募中
入组人数
86
试验地点
18
主要终点
[Group Kids] Change in BMI, Baseline (week 0) to week 68
研究概览入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Group Kids: To confirm superiority of semaglutide s.c. once-weekly versus placebo as an adjunct to a reduced-calorie diet and increased physical activity on weight management in children with obesity (ages 6 to <12 years).

入排标准

年龄范围
0 years 至 17 years（0-17 Years）
接受健康志愿者
是

入选标准

  • •Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. a. The parent(s) 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)
  • •Age, at the time of signing informed consent, of: a. Group Kids: 6 to < 12 years, b. Group Teens: 12 to < 18 years, and Tanner stage > 1
  • •BMI, at screening and randomisation, corresponding to a. Group Kids: ≥95th percentile, b. Group Teens: ≥95th percentile or ≥85th percentilea with the presence of at least 1 weight-related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or T2D
  • •History of at least one unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification programme (diet and exercise counselling) for at least 3 months (As declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records)
  • •Body weight of >45 kg at screening and randomisation.
  • •[For participants with T2D at screening the following inclusion criteria apply in addition to criteria 1-5:] Treatment with either lifestyle intervention, or treatment with metformin according to local label. Treatment with metformin should be stable (same drug(s), dose, and dosing frequency) for at least 90 days before screening
  • •[For participants with T2D at screening the following inclusion criteria apply in addition to criteria 1-5:] HbA1c ≤10.0% (86 mmol/mol) as measured by central laboratory at screening
  • •[For participants assessed by DXA scan the following additional criteria must apply]: Evaluation of the quality of the DXA scan must be performed and found acceptable by the imaging laboratory prior to randomisation
  • •[For participants assessed by DXA scan the following additional criteria must apply]: BMI ≤ 40.0 kg/m2 at screening

排除标准

  • •[Obesity related] Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening
  • •[Additional mental health for Group Teens] A Patient Health Questionnaire-9 (PHQ-9) score of ≥15 at screening
  • •[Additional mental health for Group Teens] Suicidal ideation corresponding to type 4 or 5 based on the Columbia-Suicide Severity Rating Scale (C-SSRS) within 30 days before screening
  • •[General Safety] History or presence of chronic pancreatitis (As declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records)
  • •[General Safety] Presence of acute pancreatitis within 180 days before screening (As declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records)
  • •[General Safety] Calcitonin ≥50 ng/L
  • •[General Safety] Personal, or first-degree relative’s, history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (As declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records)
  • •[General Safety] Type 1 diabetes mellitus or monogenic diabetes
  • •[General Safety] Renal impairment with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2, as calculated by the Bedside Schwartz equation (According to the current version of National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK, National Institutes of Health) and Kidney Disease Improving Global Outcomes (KDIGO) pediatric clinical practice guidelines)
  • •[General Safety] Presence or history of malignant neoplasms within the past 5 years prior to the day of screening (As declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records)
  • •[General Safety] Surgery scheduled for the duration of the study, except for minor surgical procedures, in the opinion of the investigator
  • •[Obesity related] Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed >1 year prior to screening, (2) adjustable gastric banding, if the band has been removed >1 year prior to screening, (3) intragastric balloon, if the balloon has been removed >1 year prior to screening or (4) duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed >1 year prior to screening.
  • •[General Safety] Known or suspected abuse of alcohol or recreational drugs
  • •[General Safety] Use of any medication with unknown or unspecified content within 90 days before screening
  • •[General Safety] Known or suspected hypersensitivity to study product(s) or related products
  • •[General Safety] Previous participation in this study. Participation is defined as signed informed consent
  • •[General Safety] Participation (i.e., signed informed consent) in any interventional, clinical study of an approved or non-approved investigational medicinal product within 90 days before screening
  • •[General Safety] Other participant(s) from the same household participating in any semaglutide study
  • •[General Safety] Known history of heart disease (including history of clinically significant arrhythmias or conduction delays on ECG) within 180 days before screening, new clinically significant arrhythmias or conduction delays on ECG identified at screening
  • •[General Safety] Female who is pregnant, breast feeding, intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method, as defined in Appendix 4, Section ‎10.4
  • •[General Safety] Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator’s opinion, might jeopardise the participant’s safety or compliance with the protocol
  • •[Glycaemia-related] Treatment with glucose-lowering agent(s) within 90 days before screening (except for metformin)
  • •[Obesity related] Uncontrolled thyroid disease
  • •[Glycaemia-related] Treatment with a GLP-1 receptor agonist within 180 days before screening
  • •[Diabetes related for participants with T2D] Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
  • •[Diabetes related for participants with T2D] Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies
  • •[Obesity related] Participants with endocrine, hypothalamic, or syndromic obesity
  • •[Obesity related] A self-reported (or by parent(s)/LAR where applicable) change in body weight >5% within 90 days before screening irrespective of medical record
  • •[Mental health] History of major depressive disorder within 2 years before screening (As declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records)
  • •[Mental health] Diagnosis of other severe psychiatric disorders (e.g., schizophrenia, bipolar disorder) [As declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records]
  • •[Mental health] A lifetime history of suicidal attempt (As declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records)
  • •[Mental health] Suicidal behaviour within 30 days before screening (As declared by the participant (or by parent(s)/LAR where applicable) or reported in the participant’s medical records)

结局指标

主要结局

[Group Kids] Change in BMI, Baseline (week 0) to week 68

[Group Kids] Change in BMI, Baseline (week 0) to week 68

次要结局

  • [Group Kids] [Confirmatory secondary endpoint], Improvement in weight category (Based on CDC sex- and age-specific growth charts), Baseline (week 0) to week 68
  • [Group Kids] [Supportive secondary endpoint] Change in BMI, Week 0 to week 104
  • [Group Kids] [Supportive secondary endpoint] Improvement in weight category (Based on CDC sex- and age-specific growth charts), Week 0 to week 104
  • [Group Kids] [Supportive secondary endpoint] Change in body weight, Week 0 to week 68, Week 0 to week 104
  • [Group Kids] [Supportive secondary endpoint] Change in BMI percentage of the 95th percentile (Based on CDC sex- and age-specific growth charts), Week 0 to week 68, Week 0 to week 104
  • [Group Kids] [Supportive secondary endpoint] Change in BMI, SDS (standard deviation score) [As defined by the WHO BMI-for-age growth reference chart], Week 0 to week 68, Week 0 to week 104
  • [Group Kids] [Supportive secondary endpoint] Change in waist circumference, Week 0 to week 68, Week 0 to week 104
  • [Group Kids] [Supportive secondary endpoint] Change in systolic blood pressure, Week 0 to week 68, Week 0 to week 104
  • [Group Kids] [Supportive secondary endpoint] Change in diastolic blood pressure, Week 0 to week 68, Week 0 to week 104
  • [Group Kids] [Supportive secondary endpoint] Change in total cholesterol, Week 0 to week 68, Week 0 to week 104
  • [Group Kids] [Supportive secondary endpoint] Change in HDL, Week 0 to week 68, Week 0 to week 104
  • [Group Kids] [Supportive secondary endpoint] Change in LDL, Week 0 to week 68, Week 0 to week 104
  • [Group Kids] [Supportive secondary endpoint] Change in VLDL, Week 0 to week 68, Week 0 to week 104
  • [Group Kids] [Supportive secondary endpoint] Change in triglycerides, Week 0 to week 68, Week 0 to week 104
  • [Group Kids] [Supportive secondary endpoint] Change in hs-CRP, Week 0 to week 68, Week 0 to week 104
  • [Group Kids] [Supportive secondary endpoint] Change in HbA1c, Week 0 to week 68, Week 0 to week 104
  • [Group Kids] [Supportive secondary endpoint] Change in fasting plasma glucose, Week 0 to week 68, Week 0 to week 104
  • [Group Kids] [Supportive secondary endpoint] Change in fasting insulin, Week 0 to week 68, Week 0 to week 104
  • Change in ALT, Week 0 to week 68, Week 0 to week 104
  • [Group Kids] [Supportive secondary endpoint] Change in total fat mass, by DXA (For the population who have DXA scans) relative to total body mass, Week 0 to week 68, Week 0 to week 104
  • [Group Kids] [Supportive secondary endpoint] Change in lean body mass, by DXA (For the population who have DXA scans) relative to total body mass, Week 0 to week 68, Week 0 to week 104
  • [Group Kids] [Supportive secondary endpoint] Relative change in visceral fat mass by DXA (For the population who have DXA scans), Week 0 to week 68, Week 0 to week 104
  • [Group Kids] [Supportive secondary endpoint] Participants achieving ≥5% reduction of BMI (yes/no), Week 0 to week 68, Week 0 to week 104
  • [Group Kids] [Supportive secondary endpoint] Participants achieving ≥10% reduction of BMI (yes/no), Week 0 to week 68, Week 0 to week 104
  • Participants achieving ≥15% reduction of BMI (yes/no), Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Change in BMI, Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Improvement in weight category (Based on CDC sex- and age-specific growth charts), Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Change in body weight, Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Change in BMI percentage of the 95th percentile (Based on CDC sex- and age-specific growth charts), Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Change in BMI, SDS (standard deviation score) [As defined by the WHO BMI-for-age growth reference chart], Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Change in waist circumference, Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Change in systolic blood pressure, Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Change in diastolic blood pressure, Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Change in total cholesterol, Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Change in HDL, Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Change in LDL, Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Change in VLDL, Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Change in triglycerides, Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Change in hs-CRP, Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Change in HbA1c, Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Change in fasting plasma glucose, Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Change in fasting insulin, Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Change in ALT, Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Change in total fat mass, by DXA (For the population who have DXA scans) relative to total body mass, Week 0 to week 68, Week 0 to week 104
  • Change in lean body mass, by DXA (For the population who have DXA scans) relative to total body mass, Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Relative change in visceral fat mass by DXA (For the population who have DXA scans), Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Participants achieving ≥5% reduction of BMI (yes/no), Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Participants achieving ≥10% reduction of BMI (yes/no), Week 0 to week 68, Week 0 to week 104
  • [Group Teens] [Supportive secondary endpoint] Participants achieving ≥15% reduction of BMI (yes/no), Week 0 to week 68, Week 0 to week 104
  • Treatment emergent AEs, Week 0 to week 68, Week 0 to week 111
  • Treatment emergent SAEs, Week 0 to week 68, Week 0 to week 111
  • Change in pulse Week 0 to week 68, Week 0 to week 104
  • Change in amylase, Week 0 to week 68, Week 0 to week 104
  • Change in lipase, Week 0 to week 68, Week 0 to week 104
  • Change in calcitonin, Week 0 to week 68, Week 0 to week 104
  • Change in bone mineral density, by DXA (For the population who have DXA scans)
  • Treatment emergent hypoglycaemic episodes (for T2D only) [As defined by ISPAD]

研究者

申办方类型
Pharmaceutical company
责任方
Principal Investigator
主要研究者

EU Submission Hub

Scientific

Novo Nordisk A/S

研究点 (18)

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