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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Drug: Semaglutide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Recruiting
    • Universitätsklinik Kinder-Jugendheilkunde
  • Salzburg, Austria, 5020
    • Recruiting
    • Universitätsklinik für Kinder und Jugendheilkunde Haus E
• Belgium
  • Brussel, Belgium, 1090
    • Recruiting
    • UZ Brussel
  • Edegem, Belgium, 2650
    • Recruiting
    • UZ Antwerpen - UZA - Kinderziekenhuis
  • Edegem, Belgium, 2650
    • Recruiting
    • UZA - UZ Antwerpen - Kinderziekenhuis
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven - Kindergeneeskunde
• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • Aalborg Universitetshospital
  • Aarhus, Denmark, 8200
    • Recruiting
    • Aarhus Universitetshospital, Steno Diabetes Center Aarhus
  • Holbæk, Denmark, 4300
    • Recruiting
    • Holbæk Sygehus
• Germany
  • Halle, Germany, 06120
    • Withdrawn
    • Universitatsklinikum Halle (Saale)
  • Hannover, Germany, 30173
    • Recruiting
    • Kinder- und Jugendkrankenhaus
  • Hannover, Germany, 30173
    • Not yet recruiting
    • Kinder- und Jugendkrankenhaus
  • Leipzig, Germany, 04103
    • Recruiting
    • Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin
  • Leipzig, Germany, 04103
    • Not yet recruiting
    • Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin
  • Ulm, Germany, 89075
    • Recruiting
    • Universitätsklinikum Ulm für Kinder- und Jugendmedizin
  • Ulm, Germany, 89075
    • Not yet recruiting
    • Universitätsklinikum Ulm für Kinder- und Jugendmedizin
• Israel
  • Haifa, Israel, 31096
    • Recruiting
    • Rambam Medical Center Children A Dept.
  • Petah Tikva, Israel, 49202
    • Recruiting
    • Endrocrinology & DM Schneider MC
  • Zerifin, Israel, 70300
    • Recruiting
    • Shamir (Assaf Harofe) Medical Center
• Mexico
  • Puebla, Mexico, 72190
    • Not yet recruiting
    • Consultorio de Endocrinología y Pediatría
• Portugal
  • Lisboa, Portugal, 1500-650
    • Recruiting
    • Hospital da Luz
  • Porto, Portugal, 4050-342
    • Recruiting
    • Centro Hospitalar do Porto, E.P.E
  • Porto, Portugal, 4100-180
    • Recruiting
    • CUF-Porto
• Sweden
  • Göteborg, Sweden, 41650
    • Withdrawn
    • Drottning Silvias barnsjukhus
  • Halmstad, Sweden, 30233
    • Recruiting
    • Hallands Sjukhus Halmstad
  • Uppsala, Sweden, 75185
    • Recruiting
    • Akademiska sjukhuset Uppsala
  • Uppsala, Sweden, 75185
    • Not yet recruiting
    • Akademiska sjukhuset Uppsala
• United Kingdom
  • Birmingham, United Kingdom, B4 6NH
    • Recruiting
    • Birmingham Children's Hospital
  • Bristol, United Kingdom, BS2 8BJ
    • Recruiting
    • University Hospitals Bristol & Weston NHS Foundation Trust
  • Leeds, United Kingdom, LS1 3EX
    • Recruiting
    • Leeds Children's Hospital
  • Liverpool, United Kingdom, L12 2AP
    • Recruiting
    • Alder Hey Children's Hospital
  • Liverpool, United Kingdom, L12 2AP
    • Not yet recruiting
    • Alder Hey Children's Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Withdrawn
    • Southampton General Hospital
• United States
  • California
    • Escondido, California, United States, 92025
      • Active, not recruiting
      • Neighborhood Healthcare
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • Yale School of Medicine
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Active, not recruiting
      • Columbus Research Foundation
    • Snellville, Georgia, United States, 30078
      • Active, not recruiting
      • Eastside Bariatric and Gen Surg
  • Idaho
    • Meridian, Idaho, United States, 83646
      • Active, not recruiting
      • Solaris Clinical Research
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Recruiting
      • Pennington Biom Res Ctr
    • Baton Rouge, Louisiana, United States, 70808
      • Active, not recruiting
      • Pennington Biom Res Ctr
    • Monroe, Louisiana, United States, 71201
      • Recruiting
      • Clinical Trials of America LLC
    • Monroe, Louisiana, United States, 71201
      • Active, not recruiting
      • Clinical Trials of America LLC
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Active, not recruiting
      • Barry J. Reiner, MD LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Withdrawn
      • Massachusetts General Hospital_Cary
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Active, not recruiting
      • University of Minnesota
  • Mississippi
    • Madison, Mississippi, United States, 39110
      • Not yet recruiting
      • Mississippi Center for Advanced Medicine
    • Madison, Mississippi, United States, 39110
      • Withdrawn
      • Mississippi CTR for ADV MED
  • New York
    • Buffalo, New York, United States, 14203
      • Active, not recruiting
      • UBMD Peds-Div of Endo/Diabetes
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • Withdrawn
      • WakeMed Childn Endo-Dbt_Raleig
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Active, not recruiting
      • Valley Weight Loss Clinic
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Active, not recruiting
      • Centricity Research - Ohio
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Active, not recruiting
      • UPMC Child Hosp-Pittsburgh
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Withdrawn
      • Vanderbilt University Medical Center
    • Tullahoma, Tennessee, United States, 37388
      • Active, not recruiting
      • Tullahoma Pediatrics PLLC
  • Texas
    • Austin, Texas, United States, 78731
      • Active, not recruiting
      • Texas Diabetes & Endocrinology
    • San Antonio, Texas, United States, 78207
      • Active, not recruiting
      • Univ Of Texas Hlth Science Cntr
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Recruiting
      • Health Res of Hampton Roads
    • Newport News, Virginia, United States, 23606
      • Active, not recruiting
      • Health Res of Hampton Roads
  • Wisconsin
    • Marshfield, Wisconsin, United States, 54449
      • Withdrawn
      • Marshfield Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Group Kids: Change in body mass index (BMI)	Measured in percentage (%)	From baseline (week 0) to week 68

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Group Teens: Change in BMI	Measured in %	From week 0 to week 68
Group Kids and Group Teens: Change in BMI	Measured in %	From week 0 to week 104
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.	From week 0 to week 68
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.	From week 0 to week 104
Group Kids and Group Teens: Change in body weight	Measured in percentage	From week 0 to week 68
Group Kids and Group Teens: Change in body weight	Measured in percentage	From week 0 to week 104
Group Kids and Group Teens: Change in body weight	Measured in kilograms (kg)	From week 0 to week 68
Group Kids and Group Teens: Change in body weight	Measured in kilograms (kg)	From week 0 to week 104
Group Kids and Group Teens: Change in BMI percentage of the 95th percentile	Measured in percentage points	From week 0 to week 68
Group Kids and Group Teens: Change in BMI percentage of the 95th percentile	Measured in percentage points	From week 0 to week 104
Group Kids and Group Teens: Change in waist circumference	Measured in centimeters (cm)	From week 0 to week 68
Group Kids and Group Teens: Change in waist circumference	Measured in centimeters (cm)	From week 0 to week 104
Group Kids and Group Teens: Change in systolic blood pressure	Measured in millimeters of mercury (mmHg)	From week 0 to week 68
Group Kids and Group Teens: Change in systolic blood pressure	Measured in millimeters of mercury (mmHg)	From week 0 to week 104
Group Kids and Group Teens: Change in diastolic blood pressure	Measured in mmHg	From week 0 to week 68
Group Kids and Group Teens: Change in diastolic blood pressure	Measured in mmHg	From week 0 to week 104
Group Kids and Group Teens: Change in total cholesterol	Measured in %	From week 0 to week 68
Group Kids and Group Teens: Change in total cholesterol	Measured in %	From week 0 to week 104
Group Kids and Group Teens: Change in high density lipoprotein (HDL)	Measured in %	From week 0 to week 68
Group Kids and Group Teens: Change in high density lipoprotein (HDL)	Measured in %	From week 0 to week 104
Group Kids and Group Teens: Change in low density lipoprotein (LDL)	Measured in %	From week 0 to week 68
Group Kids and Group Teens: Change in low density lipoprotein (LDL)	Measured in %	From week 0 to week 104
Group Kids and Group Teens: Change in very low density lipoprotein (VLDL)	Measured in %	From week 0 to week 68
Group Kids and Group Teens: Change in very low density lipoprotein (VLDL)	Measured in %	From week 0 to week 104
Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP)	Measured in %	From week 0 to week 68
Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP)	Measured in %	From week 0 to week 104
Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c)	Measured in % point	From week 0 to week 68
Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c)	Measured in % point	From week 0 to week 104
Group Kids and Group Teens: Change in fasting plasma glucose	Measured in millimoles per liter (mmol/L)	From week 0 to week 68
Group Kids and Group Teens: Change in fasting plasma glucose	Measured in millimoles per liter (mmol/L)	From week 0 to week 104
Group Kids and Group Teens: Change in fasting plasma glucose	Measured in milligrams per deciliter (mg/dL)	From week 0 to week 68
Group Kids and Group Teens: Change in fasting plasma glucose	Measured in milligrams per deciliter (mg/dL)	From week 0 to week 104
Group Kids and Group Teens: Change in fasting insulin	Measured in %	From week 0 to week 68
Group Kids and Group Teens: Change in fasting insulin	Measured in %	From week 0 to week 104
Group Kids and Group Teens: Change in alanine transaminase (ALT)	Measured in milliunits per liter (mU/L)	From week 0 to week 68
Group Kids and Group Teens: Change in alanine transaminase (ALT)	Measured in milliunits per liter (mU/L)	From week 0 to week 104
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	From week 0 to week 68
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	From week 0 to week 104
Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass	Measured in % points	From week 0 to week 68
Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass	Measured in % points	From week 0 to week 104
Group Kids and Group Teens: Relative change in visceral fat mass by DXA	Measured in %	From week 0 to week 68
Group Kids and Group Teens: Relative change in visceral fat mass by DXA	Measured in %	From week 0 to week 104
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	From week 0 to week 68
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	From week 0 to week 104
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	From week 0 to week 68
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	From week 0 to week 104
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	From week 0 to week 68
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	From week 0 to week 104
Group Kids and Group Teens: Number of treatment emergent adverse events (AEs)	Measured as count of events	From week 0 to week 68
Group Kids and Group Teens: Number of treatment emergent adverse events (AEs)	Measured as count of events	From week 0 to week 111
Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs)	Measured as count of events	From week 0 to week 68
Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs)	Measured as count of events	From week 0 to week 111
Group Kids and Group Teens: Change in pulse	Measured as beats per minute	From week 0 to week 68
Group Kids and Group Teens: Change in pulse	Measured as beats per minute	From week 0 to week 104
Group Kids and Group Teens: Change in amylase	Measured as units per liter (U/L)	From week 0 to week 68
Group Kids and Group Teens: Change in amylase	Measured as units per liter (U/L)	From week 0 to week 104
Group Kids and Group Teens: Change in lipase	Measured as U/L	From week 0 to week 68
Group Kids and Group Teens: Change in lipase	Measured as U/L	From week 0 to week 104
Group Kids and Group Teens: Change in calcitonin	Measured as nanograms per liter (ng/L)	From week 0 to week 68
Group Kids and Group Teens: Change in calcitonin	Measured as nanograms per liter (ng/L)	From week 0 to week 104
Group Kids and Group Teens: Change in bone mineral density, by DXA	Measured as grams per square centimeter (g/cm^2)	From week 0 to week 68
Group Kids and Group Teens: Change in bone mineral density, by DXA	Measured as grams per square centimeter (g/cm^2)	From week 0 to week 104
Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only)	Measured as count of episodes	From week 0 to week 68
Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only)	Measured as count of episodes	From week 0 to week 111
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.	From baseline (week 0) to week 68
Group Kids and Group Teens: Change in triglycerides	Measured in %	From week 0 to week 68
Group Kids and Group Teens: Change in triglycerides	Measured in %	From week 0 to week 104
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.	From week 0 to week 68
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.	From week 0 to week 104

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2023
• Primary Completion (Estimated): November 7, 2025
• Study Completion (Estimated): January 15, 2027

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Hypoglycemic Agents; Physiological Effects of Drugs; Glucagon-Like Peptide-1 Receptor Agonists; Semaglutide
• Other Study ID Numbers: NN9536-4512; U1111-1266-3808 (Other Identifier: World Health Organization (WHO)); 2022-502922-41 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No