STEP Young

Active not recruitingPhase 3

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

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

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

210

estimated

Study population

Obesity / overweight

Key I/E criterion

•HbA1c ≤10%

Primary endpoint

•BMI, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05726227

Org study IDNN9536-4512

Secondary ID2022-502922-41

Secondary IDU1111-1266-3808World Health Organization (WHO)

Timeline

Milestones

Study first posted2023-02-13actual

Study start2023-07-07actual

Primary completion2025-10-15actual

Last update posted2026-04-23actual

Study completion2026-12-07estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age6 Years

Maximum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (70)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Cardiometabolic biomarkers

Safety / tolerability / PK

Glycemic / diabetes

MASH / liver

Weight & body composition

30 endpoints

Primary/protocol endpoint

Group Kids: Change in body mass index (BMI)

Time frame:From baseline (week 0) to week 68

BMI, change

percent change from baseline, improvement

Secondary/protocol endpoint

Group Kids: Improvement in weight category

Time frame:From baseline (week 0) to week 68

categorical status, improvement

Secondary/protocol endpoint

Group Teens: Change in BMI

Time frame:From week 0 to week 68

BMI, change

percent change from baseline, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Change in BMI

Time frame:From week 0 to week 104

BMI, change

percent change from baseline, improvement

Secondary/protocol endpoint

Group Teens: Improvement in weight category

Time frame:From week 0 to week 68

categorical status, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Improvement in weight category

Time frame:From week 0 to week 104

categorical status, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Change in body weight

Time frame:From week 0 to week 68

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Change in body weight

Time frame:From week 0 to week 104

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Change in body weight

Time frame:From week 0 to week 68

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Change in body weight

Time frame:From week 0 to week 104

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Change in BMI percentage of the 95th percentile

Time frame:From week 0 to week 68

change from baseline, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Change in BMI percentage of the 95th percentile

Time frame:From week 0 to week 104

change from baseline, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Change in BMI Standard deviation score (SDS)

Time frame:From week 0 to week 68

BMI SDS, change

change from baseline, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Change in BMI SDS

Time frame:From week 0 to week 104

BMI SDS, change

change from baseline, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Change in waist circumference

Time frame:From week 0 to week 68

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Change in waist circumference

Time frame:From week 0 to week 104

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Change in total fat mass, by Dual energy X-ray absorptiometry (DXA) relative to total body mass

Time frame:From week 0 to week 68

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Change in total fat mass, by Dual energy X-ray absorptiometry (DXA) relative to total body mass

Time frame:From week 0 to week 104

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass

Time frame:From week 0 to week 68

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass

Time frame:From week 0 to week 104

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Relative change in visceral fat mass by DXA

Time frame:From week 0 to week 68

Visceral fat, change

percent change from baseline, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Relative change in visceral fat mass by DXA

Time frame:From week 0 to week 104

Visceral fat, change

percent change from baseline, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 5% reduction of BMI (yes/no)

Time frame:From week 0 to week 68

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 5% reduction of BMI (yes/no)

Time frame:From week 0 to week 104

threshold achievement, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 10% reduction of BMI (yes/no)

Time frame:From week 0 to week 68

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 10% reduction of BMI (yes/no)

Time frame:From week 0 to week 104

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 15% reduction of BMI (yes/no)

Time frame:From week 0 to week 68

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 15% reduction of BMI (yes/no)

Time frame:From week 0 to week 104

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Change in bone mineral density, by DXA

Time frame:From week 0 to week 68

change from baseline, descriptive

Secondary/protocol endpoint

Group Kids and Group Teens: Change in bone mineral density, by DXA

Time frame:From week 0 to week 104

change from baseline, descriptive

Glycemic / diabetes

8 endpoints

Secondary/protocol endpoint

Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c)

Time frame:From week 0 to week 68

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c)

Time frame:From week 0 to week 104

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Group Kids and Group Teens: Change in fasting plasma glucose

Time frame:From week 0 to week 68

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Group Kids and Group Teens: Change in fasting plasma glucose

Time frame:From week 0 to week 104

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Group Kids and Group Teens: Change in fasting plasma glucose

Time frame:From week 0 to week 68

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Group Kids and Group Teens: Change in fasting plasma glucose

Time frame:From week 0 to week 104

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Group Kids and Group Teens: Change in fasting insulin

Time frame:From week 0 to week 68

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Group Kids and Group Teens: Change in fasting insulin

Time frame:From week 0 to week 104

percent change from baseline, improvement

MASH / liver

2 endpoints

Secondary/protocol endpoint

Group Kids and Group Teens: Change in alanine transaminase (ALT)

Time frame:From week 0 to week 68

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Group Kids and Group Teens: Change in alanine transaminase (ALT)

Time frame:From week 0 to week 104

ALT, change

change from baseline, improvement

LOINC 1742-6

Cardiometabolic biomarkers

18 endpoints

Secondary/protocol endpoint

Group Kids and Group Teens: Change in systolic blood pressure

Time frame:From week 0 to week 68

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Group Kids and Group Teens: Change in systolic blood pressure

Time frame:From week 0 to week 104

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Group Kids and Group Teens: Change in diastolic blood pressure

Time frame:From week 0 to week 68

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Group Kids and Group Teens: Change in diastolic blood pressure

Time frame:From week 0 to week 104

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Group Kids and Group Teens: Change in total cholesterol

Time frame:From week 0 to week 68

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Group Kids and Group Teens: Change in total cholesterol

Time frame:From week 0 to week 104

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Group Kids and Group Teens: Change in high density lipoprotein (HDL)

Time frame:From week 0 to week 68

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Group Kids and Group Teens: Change in high density lipoprotein (HDL)

Time frame:From week 0 to week 104

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Group Kids and Group Teens: Change in low density lipoprotein (LDL)

Time frame:From week 0 to week 68

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Group Kids and Group Teens: Change in low density lipoprotein (LDL)

Time frame:From week 0 to week 104

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Group Kids and Group Teens: Change in very low density lipoprotein (VLDL)

Time frame:From week 0 to week 68

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Change in very low density lipoprotein (VLDL)

Time frame:From week 0 to week 104

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Change in triglycerides

Time frame:From week 0 to week 68

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Group Kids and Group Teens: Change in triglycerides

Time frame:From week 0 to week 104

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP)

Time frame:From week 0 to week 68

hs-CRP, change

percent change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP)

Time frame:From week 0 to week 104

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Group Kids and Group Teens: Change in pulse

Time frame:From week 0 to week 68

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Group Kids and Group Teens: Change in pulse

Time frame:From week 0 to week 104

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

12 endpoints

Secondary/protocol endpoint

Group Kids and Group Teens: Number of treatment emergent adverse events (AEs)

Time frame:From week 0 to week 68

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Group Kids and Group Teens: Number of treatment emergent adverse events (AEs)

Time frame:From week 0 to week 111

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs)

Time frame:From week 0 to week 68

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs)

Time frame:From week 0 to week 111

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Group Kids and Group Teens: Change in amylase

Time frame:From week 0 to week 68

change from baseline, descriptive

Secondary/protocol endpoint

Group Kids and Group Teens: Change in amylase

Time frame:From week 0 to week 104

change from baseline, descriptive

Secondary/protocol endpoint

Group Kids and Group Teens: Change in lipase

Time frame:From week 0 to week 68

change from baseline, descriptive

Secondary/protocol endpoint

Group Kids and Group Teens: Change in lipase

Time frame:From week 0 to week 104

change from baseline, descriptive

Secondary/protocol endpoint

Group Kids and Group Teens: Change in calcitonin

Time frame:From week 0 to week 68

Thyroid event

change from baseline, descriptive

Secondary/protocol endpoint

Group Kids and Group Teens: Change in calcitonin

Time frame:From week 0 to week 104

Thyroid event

change from baseline, descriptive

Secondary/protocol endpoint

Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only)

Time frame:From week 0 to week 68

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only)

Time frame:From week 0 to week 111

Documented hypoglycemia

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.