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

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05726227
• Other study ID #: NN9536-4512
• Secondary ID: U1111-1266-38082
• Status: Recruiting
• Phase: Phase 3
• Start date: July 7, 2023
• Est. completion date: January 15, 2027

Study information

• Verified date: June 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: January 15, 2027
• Est. primary completion date: November 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Semaglutide
Semaglutide will be administered subcutaneously once weekly.
• Placebo
Placebo will be administered subcutaneously once-weekly.

Locations

Country	Name	City	State
Austria	Universitätsklinik Kinder-Jugendheilkunde Innsbruck	Innsbruck
Austria	Universitätsklinik für Kinder und Jugendheilkunde Haus E	Salzburg
Belgium	UZ Brussel	Brussel
Belgium	UZ Antwerpen - UZA - Kinderziekenhuis	Edegem
Belgium	UZA - UZ Antwerpen - Kinderziekenhuis	Edegem
Belgium	UZ Leuven - Kindergeneeskunde	Leuven
Denmark	Aalborg Universitetshospital	Aalborg
Denmark	Aarhus Universitetshospital, Steno Diabetes Center Aarhus	Aarhus
Denmark	Holbæk Sygehus	Holbæk
Germany	Universitätsklinikum Halle (Saale)	Halle
Germany	Kinder- und Jugendkrankenhaus	Hannover
Germany	Kinder- und Jugendkrankenhaus	Hannover
Germany	Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin	Leipzig
Germany	Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin	Leipzig
Germany	Universitätsklinikum Ulm für Kinder- und Jugendmedizin	Ulm
Germany	Universitätsklinikum Ulm für Kinder- und Jugendmedizin	Ulm
Israel	Rambam Medical Center Children A Dept.	Haifa
Israel	Endrocrinology & DM Schneider MC	Petah Tikva
Israel	Shamir (Assaf Harofe) Medical Center	Zerifin
Mexico	Consultorio de Endocrinología y Pediatría	Puebla
Portugal	Hospital da Luz	Lisboa
Portugal	CUF-Porto	Porto
Portugal	Unidade Local de Saúde de Santo António, E.P.E	Porto
Sweden	Drottning Silvias barnsjukhus	Göteborg
Sweden	Hallands sjukhus Halmstad	Halmstad
Sweden	Akademiska sjukhuset Uppsala	Uppsala
Sweden	Akademiska sjukhuset Uppsala	Uppsala
United Kingdom	Birmingham Children's Hospital	Birmingham
United Kingdom	University Hospitals Bristol & Weston NHS Foundation Trust	Bristol
United Kingdom	Leeds Children's Hospital	Leeds
United Kingdom	Alder Hey Children's Hospital	Liverpool
United Kingdom	Alder Hey Children's Hospital	Liverpool
United Kingdom	Southampton General Hospital	Southampton
United States	Texas Diabetes & Endocrinology	Austin	Texas
United States	Barry J. Reiner, MD LLC	Baltimore	Maryland
United States	Pennington Biom Res Ctr	Baton Rouge	Louisiana
United States	Pennington Biom Res Ctr	Baton Rouge	Louisiana
United States	Massachusetts General Hospital_Cary	Boston	Massachusetts
United States	UBMD Peds-Div of Endo/Diabetes	Buffalo	New York
United States	Centricity Research - Ohio	Columbus	Ohio
United States	Columbus Research Foundation	Columbus	Georgia
United States	Neighborhood Healthcare	Escondido	California
United States	Valley Weight Loss Clinic	Fargo	North Dakota
United States	Mississippi Center for Advanced Medicine	Madison	Mississippi
United States	Mississippi CTR for ADV MED	Madison	Mississippi
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Solaris Clinical Research	Meridian	Idaho
United States	University of Minnesota	Minneapolis	Minnesota
United States	Clinical Trials of America LLC	Monroe	Louisiana
United States	Clinical Trials of America LLC	Monroe	Louisiana
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale School of Medicine	New Haven	Connecticut
United States	Health Res of Hampton Roads	Newport News	Virginia
United States	Health Res of Hampton Roads	Newport News	Virginia
United States	UPMC Child Hosp-Pittsburgh	Pittsburgh	Pennsylvania
United States	WakeMed Childn Endo-Dbt_Raleig	Raleigh	North Carolina
United States	Univ Of Texas Hlth Science Cntr	San Antonio	Texas
United States	Eastside Bariatric and Gen Surg	Snellville	Georgia
United States	Tullahoma Pediatrics PLLC	Tullahoma	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Denmark,  Germany,  Israel,  Mexico,  Portugal,  Sweden,  United Kingdom, 

Outcome

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