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A Research Study on How Well Semaglutide Helps Children and Teenagers With Excess Body Weight Lose Weight (STEP Young)

Primary Purpose

Obesity

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Semaglutide
Placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, 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 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) Age at the time of signing informed consent. a)Group Kids: 6 to less than 12 years. b) Group Teens: 12 to less than 18 years and Tanner stage greater than 1 Body mass index (BMI), at screening and randomisation, corresponding to a) Group Kids: greater than or equal to 95th percentile. b) Group Teens: greater than or equal to 95th percentile or greater than or equal to 85th percentile with the presence of at least 1 weight-related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or type 2 diabetes mellitus (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 Body weight of greater than 45 kilogram (kg) at screening and randomisation For participants with T2D at screening, the following additional criterion applies: glycated haemoglobin (HbA1c) less than or equal to 10.0 percent (86 millimoles per mole [mmol/mol]) as measured by central laboratory at screening Exclusion Criteria: Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: a) liposuction and/or abdominoplasty, if performed greater than 1 year prior to screening. b) adjustable gastric banding, if the band has been removed greater than 1 year prior to screening. c) intragastric balloon, if the balloon has been removed greater than 1 year prior to screening. d)duodenal-jejunal bypass liner (e.g., nonbarrier), if the sleeve has been removed greater than 1 year prior to screening Type 1 diabetes mellitus or monogenic diabetes Participants with endocrine, hypothalamic, or syndromic obesity For participants with T2D at screening, the following additional key criterion applies: 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

Sites / Locations

  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
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  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
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  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
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  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group Kids

Group Teens

Arm Description

Participants in the age group 6 to less than (<) 12 years will receive once weekly subcutaneous (s.c.) injection of either semaglutide or placebo matched to semaglutide in dose escalation fashion for 16 weeks (0.25 mg from weeks 0-4, 0.5 mg from weeks 5-8, 1.0 mg from weeks 9-12 and 1.7 mg from weeks 13-16) followed by 2.4 mg as maintenance dose for 88 weeks as an adjunct to a reduced-calorie diet and increased physical activity.

Participants in the age group 12 to < 18 years will receive once weekly s.c. injection of either semaglutide or placebo matched to semaglutide in dose escalation fashion for 16 weeks (0.25 mg from weeks 0-4, 0.5 mg from weeks 5-8, 1.0 mg from weeks 9-12 and 1.7 mg from weeks 13-16) followed by 2.4 mg as maintenance dose for 88 weeks as an adjunct to a reduced-calorie diet and increased physical activity.

Outcomes

Primary Outcome Measures

Group Kids: Change in body mass index (BMI)
Measured in percentage (%)

Secondary Outcome Measures

Group Kids: Improvement in weight category
Measured as count of participants. Weight categories based on growth charts from Center for Disease Control (CDC).gov: Normal weight= BMI less than (<) 85th percentile, Overweight= BMI greater than or equal to (>=) 85th - <95th percentile, Obesity class I= BMI >=95th - <120% of the 95th percentile, Obesity class II= BMI >=120% - <140% of the 95th percentile, Obesity class III= BMI >=140% of the 95th percentile.
Group Teens: Change in BMI
Measured in %
Group Kids and Group Teens: Change in BMI
Measured in %
Group Teens: Improvement in weight category
Measured as count of participants. Weight categories based on growth charts from CDC.gov: Normal weight= BMI less than (<) 85th percentile, Overweight= BMI greater than or equal to (>=) 85th - <95th percentile, Obesity class I= BMI >=95th - <120% of the 95th percentile, Obesity class II= BMI >=120% - <140% of the 95th percentile, Obesity class III= BMI >=140% of the 95th percentile.
Group Kids and Group Teens: Improvement in weight category
Measured as count of participants. Weight categories based on growth charts from CDC.gov: Normal weight= BMI less than (<) 85th percentile, Overweight= BMI greater than or equal to (>=) 85th - <95th percentile, Obesity class I= BMI >=95th - <120% of the 95th percentile, Obesity class II= BMI >=120% - <140% of the 95th percentile, Obesity class III= BMI >=140% of the 95th percentile.
Group Kids and Group Teens: Change in body weight
Measured in percentage
Group Kids and Group Teens: Change in body weight
Measured in percentage
Group Kids and Group Teens: Change in body weight
Measured in kilograms (kg)
Group Kids and Group Teens: Change in body weight
Measured in kilograms (kg)
Group Kids and Group Teens: Change in BMI percentage of the 95th percentile
Measured in percentage points
Group Kids and Group Teens: Change in BMI percentage of the 95th percentile
Measured in percentage points
Group Kids and Group Teens: Change in BMI Standard deviation score (SDS)
Measured as score on a scale. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.
Group Kids and Group Teens: Change in BMI SDS
Measured as score in a scale. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.
Group Kids and Group Teens: Change in waist circumference
Measured in centimeters (cm)
Group Kids and Group Teens: Change in waist circumference
Measured in centimeters (cm)
Group Kids and Group Teens: Change in systolic blood pressure
Measured in millimeters of mercury (mmHg)
Group Kids and Group Teens: Change in systolic blood pressure
Measured in millimeters of mercury (mmHg)
Group Kids and Group Teens: Change in diastolic blood pressure
Measured in mmHg
Group Kids and Group Teens: Change in diastolic blood pressure
Measured in mmHg
Group Kids and Group Teens: Change in total cholesterol
Measured in %
Group Kids and Group Teens: Change in total cholesterol
Measured in %
Group Kids and Group Teens: Change in high density lipoprotein (HDL)
Measured in %
Group Kids and Group Teens: Change in high density lipoprotein (HDL)
Measured in %
Group Kids and Group Teens: Change in low density lipoprotein (LDL)
Measured in %
Group Kids and Group Teens: Change in low density lipoprotein (LDL)
Measured in %
Group Kids and Group Teens: Change in very low density lipoprotein (VLDL)
Measured in %
Group Kids and Group Teens: Change in very low density lipoprotein (VLDL)
Measured in %
Group Kids and Group Teens: Change in triglycerides
Measured in %
Group Kids and Group Teens: Change in triglycerides
Measured in %
Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP)
Measured in %
Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP)
Measured in %
Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c)
Measured in % point
Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c)
Measured in % point
Group Kids and Group Teens: Change in fasting plasma glucose
Measured in millimoles per liter (mmol/L)
Group Kids and Group Teens: Change in fasting plasma glucose
Measured in millimoles per liter (mmol/L)
Group Kids and Group Teens: Change in fasting plasma glucose
Measured in milligrams per deciliter (mg/dL)
Group Kids and Group Teens: Change in fasting plasma glucose
Measured in milligrams per deciliter (mg/dL)
Group Kids and Group Teens: Change in fasting insulin
Measured in %
Group Kids and Group Teens: Change in fasting insulin
Measured in %
Group Kids and Group Teens: Change in alanine transaminase (ALT)
Measured in milliunits per liter (mU/L)
Group Kids and Group Teens: Change in alanine transaminase (ALT)
Measured in milliunits per liter (mU/L)
Group Kids and Group Teens: Change in total fat mass, by Dual energy X-ray absorptiometry (DXA) relative to total body mass
Measured in % points
Group Kids and Group Teens: Change in total fat mass, by Dual energy X-ray absorptiometry (DXA) relative to total body mass
Measured in % points
Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass
Measured in % points
Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass
Measured in % points
Group Kids and Group Teens: Relative change in visceral fat mass by DXA
Measured in %
Group Kids and Group Teens: Relative change in visceral fat mass by DXA
Measured in %
Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 5% reduction of BMI (yes/no)
Measured in count of participants
Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 5% reduction of BMI (yes/no)
Measured in count of participants
Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 10% reduction of BMI (yes/no)
Measured in count of participants
Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 10% reduction of BMI (yes/no)
Measured in count of participants
Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 15% reduction of BMI (yes/no)
Measured in count of participants
Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 15% reduction of BMI (yes/no)
Measured in count of participants
Group Kids and Group Teens: Number of treatment emergent adverse events (AEs)
Measured as count of events
Group Kids and Group Teens: Number of treatment emergent adverse events (AEs)
Measured as count of events
Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs)
Measured as count of events
Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs)
Measured as count of events
Group Kids and Group Teens: Change in pulse
Measured as beats per minute
Group Kids and Group Teens: Change in pulse
Measured as beats per minute
Group Kids and Group Teens: Change in amylase
Measured as units per liter (U/L)
Group Kids and Group Teens: Change in amylase
Measured as units per liter (U/L)
Group Kids and Group Teens: Change in lipase
Measured as U/L
Group Kids and Group Teens: Change in lipase
Measured as U/L
Group Kids and Group Teens: Change in calcitonin
Measured as nanograms per liter (ng/L)
Group Kids and Group Teens: Change in calcitonin
Measured as nanograms per liter (ng/L)
Group Kids and Group Teens: Change in bone mineral density, by DXA
Measured as grams per square centimeter (g/cm^2)
Group Kids and Group Teens: Change in bone mineral density, by DXA
Measured as grams per square centimeter (g/cm^2)
Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only)
Measured as count of episodes
Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only)
Measured as count of episodes

Full Information

First Posted
February 3, 2023
Last Updated
October 9, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05726227
Brief Title
A Research Study on How Well Semaglutide Helps Children and Teenagers With Excess Body Weight Lose Weight
Acronym
STEP Young
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2023 (Actual)
Primary Completion Date
November 7, 2025 (Anticipated)
Study Completion Date
January 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will look at how well semaglutide helps children and teenagers losing weight. This will be tested by comparing the effect on body weight in children and teenagers taking semaglutide in comparison to placebo, a "dummy" medicine. In addition to taking the medicine, the child's parent and the child will have talks with study staff about healthy food choices, how to be more physically active and what your child can do to try to lose weight. The child will either get semaglutide or a "dummy" medicine. Which treatment the child will get is decided by chance. Semaglutide is an approved medicine for type 2 diabetes and weight management in adults. The child will get one injection once a week. The study medicine is injected with a thin needle in the stomach, thighs or upper arms. The study will last for about 2 ½ years (132 weeks).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group Kids
Arm Type
Experimental
Arm Description
Participants in the age group 6 to less than (<) 12 years will receive once weekly subcutaneous (s.c.) injection of either semaglutide or placebo matched to semaglutide in dose escalation fashion for 16 weeks (0.25 mg from weeks 0-4, 0.5 mg from weeks 5-8, 1.0 mg from weeks 9-12 and 1.7 mg from weeks 13-16) followed by 2.4 mg as maintenance dose for 88 weeks as an adjunct to a reduced-calorie diet and increased physical activity.
Arm Title
Group Teens
Arm Type
Experimental
Arm Description
Participants in the age group 12 to < 18 years will receive once weekly s.c. injection of either semaglutide or placebo matched to semaglutide in dose escalation fashion for 16 weeks (0.25 mg from weeks 0-4, 0.5 mg from weeks 5-8, 1.0 mg from weeks 9-12 and 1.7 mg from weeks 13-16) followed by 2.4 mg as maintenance dose for 88 weeks as an adjunct to a reduced-calorie diet and increased physical activity.
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
Semaglutide will be administered subcutaneously once weekly.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered subcutaneously once-weekly.
Primary Outcome Measure Information:
Title
Group Kids: Change in body mass index (BMI)
Description
Measured in percentage (%)
Time Frame
From baseline (week 0) to week 68
Secondary Outcome Measure Information:
Title
Group Kids: Improvement in weight category
Description
Measured as count of participants. Weight categories based on growth charts from Center for Disease Control (CDC).gov: Normal weight= BMI less than (<) 85th percentile, Overweight= BMI greater than or equal to (>=) 85th - <95th percentile, Obesity class I= BMI >=95th - <120% of the 95th percentile, Obesity class II= BMI >=120% - <140% of the 95th percentile, Obesity class III= BMI >=140% of the 95th percentile.
Time Frame
From baseline (week 0) to week 68
Title
Group Teens: Change in BMI
Description
Measured in %
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in BMI
Description
Measured in %
Time Frame
From week 0 to week 104
Title
Group Teens: Improvement in weight category
Description
Measured as count of participants. Weight categories based on growth charts from CDC.gov: Normal weight= BMI less than (<) 85th percentile, Overweight= BMI greater than or equal to (>=) 85th - <95th percentile, Obesity class I= BMI >=95th - <120% of the 95th percentile, Obesity class II= BMI >=120% - <140% of the 95th percentile, Obesity class III= BMI >=140% of the 95th percentile.
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Improvement in weight category
Description
Measured as count of participants. Weight categories based on growth charts from CDC.gov: Normal weight= BMI less than (<) 85th percentile, Overweight= BMI greater than or equal to (>=) 85th - <95th percentile, Obesity class I= BMI >=95th - <120% of the 95th percentile, Obesity class II= BMI >=120% - <140% of the 95th percentile, Obesity class III= BMI >=140% of the 95th percentile.
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in body weight
Description
Measured in percentage
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in body weight
Description
Measured in percentage
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in body weight
Description
Measured in kilograms (kg)
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in body weight
Description
Measured in kilograms (kg)
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in BMI percentage of the 95th percentile
Description
Measured in percentage points
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in BMI percentage of the 95th percentile
Description
Measured in percentage points
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in BMI Standard deviation score (SDS)
Description
Measured as score on a scale. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in BMI SDS
Description
Measured as score in a scale. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in waist circumference
Description
Measured in centimeters (cm)
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in waist circumference
Description
Measured in centimeters (cm)
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in systolic blood pressure
Description
Measured in millimeters of mercury (mmHg)
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in systolic blood pressure
Description
Measured in millimeters of mercury (mmHg)
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in diastolic blood pressure
Description
Measured in mmHg
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in diastolic blood pressure
Description
Measured in mmHg
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in total cholesterol
Description
Measured in %
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in total cholesterol
Description
Measured in %
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in high density lipoprotein (HDL)
Description
Measured in %
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in high density lipoprotein (HDL)
Description
Measured in %
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in low density lipoprotein (LDL)
Description
Measured in %
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in low density lipoprotein (LDL)
Description
Measured in %
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in very low density lipoprotein (VLDL)
Description
Measured in %
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in very low density lipoprotein (VLDL)
Description
Measured in %
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in triglycerides
Description
Measured in %
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in triglycerides
Description
Measured in %
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP)
Description
Measured in %
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP)
Description
Measured in %
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c)
Description
Measured in % point
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c)
Description
Measured in % point
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in fasting plasma glucose
Description
Measured in millimoles per liter (mmol/L)
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in fasting plasma glucose
Description
Measured in millimoles per liter (mmol/L)
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in fasting plasma glucose
Description
Measured in milligrams per deciliter (mg/dL)
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in fasting plasma glucose
Description
Measured in milligrams per deciliter (mg/dL)
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in fasting insulin
Description
Measured in %
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in fasting insulin
Description
Measured in %
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in alanine transaminase (ALT)
Description
Measured in milliunits per liter (mU/L)
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in alanine transaminase (ALT)
Description
Measured in milliunits per liter (mU/L)
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in total fat mass, by Dual energy X-ray absorptiometry (DXA) relative to total body mass
Description
Measured in % points
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in total fat mass, by Dual energy X-ray absorptiometry (DXA) relative to total body mass
Description
Measured in % points
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass
Description
Measured in % points
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass
Description
Measured in % points
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Relative change in visceral fat mass by DXA
Description
Measured in %
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Relative change in visceral fat mass by DXA
Description
Measured in %
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 5% reduction of BMI (yes/no)
Description
Measured in count of participants
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 5% reduction of BMI (yes/no)
Description
Measured in count of participants
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 10% reduction of BMI (yes/no)
Description
Measured in count of participants
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 10% reduction of BMI (yes/no)
Description
Measured in count of participants
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 15% reduction of BMI (yes/no)
Description
Measured in count of participants
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 15% reduction of BMI (yes/no)
Description
Measured in count of participants
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Number of treatment emergent adverse events (AEs)
Description
Measured as count of events
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Number of treatment emergent adverse events (AEs)
Description
Measured as count of events
Time Frame
From week 0 to week 111
Title
Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs)
Description
Measured as count of events
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs)
Description
Measured as count of events
Time Frame
From week 0 to week 111
Title
Group Kids and Group Teens: Change in pulse
Description
Measured as beats per minute
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in pulse
Description
Measured as beats per minute
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in amylase
Description
Measured as units per liter (U/L)
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in amylase
Description
Measured as units per liter (U/L)
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in lipase
Description
Measured as U/L
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in lipase
Description
Measured as U/L
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in calcitonin
Description
Measured as nanograms per liter (ng/L)
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in calcitonin
Description
Measured as nanograms per liter (ng/L)
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Change in bone mineral density, by DXA
Description
Measured as grams per square centimeter (g/cm^2)
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Change in bone mineral density, by DXA
Description
Measured as grams per square centimeter (g/cm^2)
Time Frame
From week 0 to week 104
Title
Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only)
Description
Measured as count of episodes
Time Frame
From week 0 to week 68
Title
Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only)
Description
Measured as count of episodes
Time Frame
From week 0 to week 111

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, 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 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) Age at the time of signing informed consent. a)Group Kids: 6 to less than 12 years. b) Group Teens: 12 to less than 18 years and Tanner stage greater than 1 Body mass index (BMI), at screening and randomisation, corresponding to a) Group Kids: greater than or equal to 95th percentile. b) Group Teens: greater than or equal to 95th percentile or greater than or equal to 85th percentile with the presence of at least 1 weight-related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or type 2 diabetes mellitus (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 Body weight of greater than 45 kilogram (kg) at screening and randomisation For participants with T2D at screening, the following additional criterion applies: glycated haemoglobin (HbA1c) less than or equal to 10.0 percent (86 millimoles per mole [mmol/mol]) as measured by central laboratory at screening Exclusion Criteria: Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: a) liposuction and/or abdominoplasty, if performed greater than 1 year prior to screening. b) adjustable gastric banding, if the band has been removed greater than 1 year prior to screening. c) intragastric balloon, if the balloon has been removed greater than 1 year prior to screening. d)duodenal-jejunal bypass liner (e.g., nonbarrier), if the sleeve has been removed greater than 1 year prior to screening Type 1 diabetes mellitus or monogenic diabetes Participants with endocrine, hypothalamic, or syndromic obesity For participants with T2D at screening, the following additional key criterion applies: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novo Nordisk
Phone
(+1) 866-867-7178
Email
clinicaltrials@novonordisk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency dept. 2834
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Madison
State/Province
Mississippi
ZIP/Postal Code
39110
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Holbæk
ZIP/Postal Code
4300
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Halle
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Hannover
ZIP/Postal Code
30173
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Petah Tikva
ZIP/Postal Code
49202
Country
Israel
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Puebla
ZIP/Postal Code
72190
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Porto
ZIP/Postal Code
4050-342
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Porto
ZIP/Postal Code
4100-180
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Göteborg
ZIP/Postal Code
41650
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Halmstad
ZIP/Postal Code
30233
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Bristol
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Liverpool
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
IPD Sharing URL
http://novonordisk-trials.com

Learn more about this trial

A Research Study on How Well Semaglutide Helps Children and Teenagers With Excess Body Weight Lose Weight

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