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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05726227

Collaborator

(none)

210

Enrollment

Locations

Arms

42.3

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: Semaglutide Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jul 7, 2023

Anticipated Primary Completion Date :

Nov 7, 2025

Anticipated Study Completion Date :

Jan 15, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group Kids 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.	Drug: Semaglutide Semaglutide will be administered subcutaneously once weekly. Drug: Placebo Placebo will be administered subcutaneously once-weekly.
Experimental: Group Teens 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.	Drug: Semaglutide Semaglutide will be administered subcutaneously once weekly. Drug: Placebo Placebo will be administered subcutaneously once-weekly.

Arm

Intervention/Treatment

Experimental: Group Kids

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.

Drug: Semaglutide

Semaglutide will be administered subcutaneously once weekly.

Drug: Placebo

Placebo will be administered subcutaneously once-weekly.

Experimental: Group Teens

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.

Drug: Semaglutide

Semaglutide will be administered subcutaneously once weekly.

Drug: Placebo

Placebo will be administered subcutaneously once-weekly.

Outcome Measures

Primary Outcome Measures

Group Kids: Change in body mass index (BMI) [From baseline (week 0) to week 68]
Measured in percentage (%)

Secondary Outcome Measures

Group Kids: Improvement in weight category [From baseline (week 0) to week 68]
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 Teens: Change in BMI [From week 0 to week 68]
Measured in %
Group Kids and Group Teens: Change in BMI [From week 0 to week 104]
Measured in %
Group Teens: Improvement in weight category [From week 0 to week 68]
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 [From week 0 to week 104]
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 [From week 0 to week 68]
Measured in percentage
Group Kids and Group Teens: Change in body weight [From week 0 to week 104]
Measured in percentage
Group Kids and Group Teens: Change in body weight [From week 0 to week 68]
Measured in kilograms (kg)
Group Kids and Group Teens: Change in body weight [From week 0 to week 104]
Measured in kilograms (kg)
Group Kids and Group Teens: Change in BMI percentage of the 95th percentile [From week 0 to week 68]
Measured in percentage points
Group Kids and Group Teens: Change in BMI percentage of the 95th percentile [From week 0 to week 104]
Measured in percentage points
Group Kids and Group Teens: Change in BMI Standard deviation score (SDS) [From week 0 to week 68]
Measured as score on a scale.
Group Kids and Group Teens: Change in BMI SDS [From week 0 to week 104]
Measured as score in a scale.
Group Kids and Group Teens: Change in waist circumference [From week 0 to week 68]
Measured in centimeters (cm)
Group Kids and Group Teens: Change in waist circumference [From week 0 to week 104]
Measured in centimeters (cm)
Group Kids and Group Teens: Change in systolic blood pressure [From week 0 to week 68]
Measured in millimeters of mercury (mmHg)
Group Kids and Group Teens: Change in systolic blood pressure [From week 0 to week 104]
Measured in millimeters of mercury (mmHg)
Group Kids and Group Teens: Change in diastolic blood pressure [From week 0 to week 68]
Measured in mmHg
Group Kids and Group Teens: Change in diastolic blood pressure [From week 0 to week 104]
Measured in mmHg
Group Kids and Group Teens: Change in total cholesterol [From week 0 to week 68]
Measured in %
Group Kids and Group Teens: Change in total cholesterol [From week 0 to week 104]
Measured in %
Group Kids and Group Teens: Change in high density lipoprotein (HDL) [From week 0 to week 68]
Measured in %
Group Kids and Group Teens: Change in high density lipoprotein (HDL) [From week 0 to week 104]
Measured in %
Group Kids and Group Teens: Change in low density lipoprotein (LDL) [From week 0 to week 68]
Measured in %
Group Kids and Group Teens: Change in low density lipoprotein (LDL) [From week 0 to week 104]
Measured in %
Group Kids and Group Teens: Change in very low density lipoprotein (VLDL) [From week 0 to week 68]
Measured in %
Group Kids and Group Teens: Change in very low density lipoprotein (VLDL) [From week 0 to week 104]
Measured in %
Group Kids and Group Teens: Change in tryglycerides [From week 0 to week 68]
Measured in %
Group Kids and Group Teens: Change in tryglycerides [From week 0 to week 104]
Measured in %
Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP) [From week 0 to week 68]
Measured in %
Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP) [From week 0 to week 104]
Measured in %
Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c) [From week 0 to week 68]
Measured in % point
Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c) [From week 0 to week 104]
Measured in % point
Group Kids and Group Teens: Change in fasting plasma glucose [From week 0 to week 68]
Measured in millimoles per liter (mmol/L)
Group Kids and Group Teens: Change in fasting plasma glucose [From week 0 to week 104]
Measured in millimoles per liter (mmol/L)
Group Kids and Group Teens: Change in fasting plasma glucose [From week 0 to week 68]
Measured in milligrams per deciliter (mg/dL)
Group Kids and Group Teens: Change in fasting plasma glucose [From week 0 to week 104]
Measured in milligrams per deciliter (mg/dL)
Group Kids and Group Teens: Change in fasting insulin [From week 0 to week 68]
Measured in %
Group Kids and Group Teens: Change in fasting insulin [From week 0 to week 104]
Measured in %
Group Kids and Group Teens: Change in alanine transaminase (ALT) [From week 0 to week 68]
Measured in milliunits per liter (mU/L)
Group Kids and Group Teens: Change in alanine transaminase (ALT) [From week 0 to week 104]
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 [From week 0 to week 68]
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 [From week 0 to week 104]
Measured in % points
Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass [From week 0 to week 68]
Measured in % points
Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass [From week 0 to week 104]
Measured in % points
Group Kids and Group Teens: Relative change in visceral fat mass by DXA [From week 0 to week 68]
Measured in %
Group Kids and Group Teens: Relative change in visceral fat mass by DXA [From week 0 to week 104]
Measured in %
Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 5% reduction of BMI (yes/no) [From week 0 to week 68]
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) [From week 0 to week 104]
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) [From week 0 to week 68]
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) [From week 0 to week 104]
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) [From week 0 to week 68]
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) [From week 0 to week 104]
Measured in count of participants
Group Kids and Group Teens: Number of treatment emergent adverse events (AEs) [From week 0 to week 68]
Measured as count of events
Group Kids and Group Teens: Number of treatment emergent adverse events (AEs) [From week 0 to week 111]
Measured as count of events
Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs) [From week 0 to week 68]
Measured as count of events
Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs) [From week 0 to week 111]
Measured as count of events
Group Kids and Group Teens: Change in pulse [From week 0 to week 68]
Measured as beats per minute
Group Kids and Group Teens: Change in pulse [From week 0 to week 104]
Measured as beats per minute
Group Kids and Group Teens: Change in amylase [From week 0 to week 68]
Measured as units per liter (U/L)
Group Kids and Group Teens: Change in amylase [From week 0 to week 104]
Measured as units per liter (U/L)
Group Kids and Group Teens: Change in lipase [From week 0 to week 68]
Measured as U/L
Group Kids and Group Teens: Change in lipase [From week 0 to week 104]
Measured as U/L
Group Kids and Group Teens: Change in calcitonin [From week 0 to week 68]
Measured as nanograms per liter (ng/L)
Group Kids and Group Teens: Change in calcitonin [From week 0 to week 104]
Measured as nanograms per liter (ng/L)
Group Kids and Group Teens: Change in bone mineral density, by DXA [From week 0 to week 68]
Measured as grams per square centimeter (g/cm^2)
Group Kids and Group Teens: Change in bone mineral density, by DXA [From week 0 to week 104]
Measured as grams per square centimeter (g/cm^2)
Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only) [From week 0 to week 68]
Measured as count of episodes
Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only) [From week 0 to week 111]
Measured as count of episodes

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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.

intragastric balloon, if the balloon has been removed greater than 1 year prior to screening. d)duodenal-jejunal bypass liner (e.g., Endobarrier), 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Novo Nordisk Investigational Site	Innsbruck	Austria	6020
2	Novo Nordisk Investigational Site	Salzburg	Austria	5020
3	Novo Nordisk Investigational Site	Brussel	Belgium	1090
4	Novo Nordisk Investigational Site	Edegem	Belgium	2650
5	Novo Nordisk Investigational Site	Leuven	Belgium	3000
6	Novo Nordisk Investigational Site	Halle	Germany	06120
7	Novo Nordisk Investigational Site	Hannover	Germany	30173
8	Novo Nordisk Investigational Site	Leipzig	Germany	04103
9	Novo Nordisk Investigational Site	Ulm	Germany	89075
10	Novo Nordisk Investigational Site	Lisboa	Portugal	1500-650
11	Novo Nordisk Investigational Site	Porto	Portugal	4050-342
12	Novo Nordisk Investigational Site	Porto	Portugal	4100-180
13	Novo Nordisk Investigational Site	Göteborg	Sweden	41650
14	Novo Nordisk Investigational Site	Uppsala	Sweden	75185

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT05726227

Other Study ID Numbers:

NN9536-4512
U1111-1266-3808
2022-502922-41

First Posted:

Feb 13, 2023

Last Update Posted:

Feb 13, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity

Study Results

No Results Posted as of Feb 13, 2023