Clinical trial NCT05726227: A Research Study on How Well Semaglutide Helps Children and Teenagers With Excess Body Weight Lose Weight
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-02-13
Enrollment: 210
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Group Kids: Change in body mass index (BMI)
timeFrame: From baseline (week 0) to week 68
Secondary outcomes:
measure: Group Kids: Improvement in weight category
timeFrame: From baseline (week 0) to week 68
measure: Group Teens: Change in BMI
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in BMI
timeFrame: From week 0 to week 104
measure: Group Teens: Improvement in weight category
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Improvement in weight category
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in body weight
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in body weight
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in body weight
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in body weight
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in BMI percentage of the 95th percentile
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in BMI percentage of the 95th percentile
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in BMI Standard deviation score (SDS)
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in BMI SDS
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in waist circumference
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in waist circumference
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in systolic blood pressure
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in systolic blood pressure
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in diastolic blood pressure
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in diastolic blood pressure
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in total cholesterol
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in total cholesterol
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in high density lipoprotein (HDL)
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in high density lipoprotein (HDL)
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in low density lipoprotein (LDL)
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in low density lipoprotein (LDL)
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in very low density lipoprotein (VLDL)
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in very low density lipoprotein (VLDL)
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in triglycerides
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in triglycerides
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP)
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP)
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c)
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c)
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in fasting plasma glucose
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in fasting plasma glucose
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in fasting plasma glucose
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in fasting plasma glucose
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in fasting insulin
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in fasting insulin
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in alanine transaminase (ALT)
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in alanine transaminase (ALT)
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in total fat mass, by Dual energy X-ray absorptiometry (DXA) relative to total body mass
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in total fat mass, by Dual energy X-ray absorptiometry (DXA) relative to total body mass
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Relative change in visceral fat mass by DXA
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Relative change in visceral fat mass by DXA
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 5% reduction of BMI (yes/no)
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 5% reduction of BMI (yes/no)
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 10% reduction of BMI (yes/no)
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 10% reduction of BMI (yes/no)
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 15% reduction of BMI (yes/no)
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 15% reduction of BMI (yes/no)
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Number of treatment emergent adverse events (AEs)
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Number of treatment emergent adverse events (AEs)
timeFrame: From week 0 to week 111
measure: Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs)
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs)
timeFrame: From week 0 to week 111
measure: Group Kids and Group Teens: Change in pulse
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in pulse
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in amylase
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in amylase
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in lipase
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in lipase
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in calcitonin
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in calcitonin
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Change in bone mineral density, by DXA
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Change in bone mineral density, by DXA
timeFrame: From week 0 to week 104
measure: Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only)
timeFrame: From week 0 to week 68
measure: Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only)
timeFrame: From week 0 to week 111
Other outcomes:
Locations:
city: Escondido
country: United States
facility: Neighborhood Healthcare
state: California
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Columbus
country: United States
facility: Columbus Research Foundation
state: Georgia
city: Snellville
country: United States
facility: Eastside Bariatric and Gen Surg
state: Georgia
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Baton Rouge
country: United States
facility: Pennington Biom Res Ctr
state: Louisiana
city: Monroe
country: United States
facility: Clinical Trials of America LLC
state: Louisiana
city: Baltimore
country: United States
facility: Barry J. Reiner, MD LLC
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Madison
country: United States
facility: Mississippi Center for Advanced Medicine
state: Mississippi
city: Buffalo
country: United States
facility: UBMD Peds-Div of Endo/Diabetes
state: New York
city: Fargo
country: United States
facility: Valley Weight Loss Clinic
state: North Dakota
city: Columbus
country: United States
facility: Centricity Research - Ohio
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Child Hosp-Pittsburgh
state: Pennsylvania
city: Tullahoma
country: United States
facility: Tullahoma Pediatrics PLLC
state: Tennessee
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology
state: Texas
city: San Antonio
country: United States
facility: Univ Of Texas Hlth Science Cntr
state: Texas
city: Newport News
country: United States
facility: Health Res of Hampton Roads
state: Virginia
city: Innsbruck
country: Austria
facility: Universitätsklinik Kinder-Jugendheilkunde Innsbruck
city: Salzburg
country: Austria
facility: Universitätsklinik für Kinder und Jugendheilkunde Haus E
city: Brussel
country: Belgium
facility: UZ Brussel
city: Edegem
country: Belgium
facility: UZ Antwerpen - UZA - Kinderziekenhuis
city: Edegem
country: Belgium
facility: UZA - UZ Antwerpen - Kinderziekenhuis
city: Leuven
country: Belgium
facility: UZ Leuven - Kindergeneeskunde
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Steno Diabetes Center Aarhus
city: Holbæk
country: Denmark
facility: Holbæk Sygehus
city: Hannover
country: Germany
facility: Auf der Bult - Klinik für Diabetologie, Endokrinologie, Gastroenterologie und Klinische Forschung
city: Hannover
country: Germany
facility: Kinder- und Jugendkrankenhaus
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig - Klinik und Poliklinik für Kinder- und Jugendmedizin
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm für Kinder- und Jugendmedizin
city: Haifa
country: Israel
facility: Rambam Medical Center Children A Dept.
city: Petah Tikva
country: Israel
facility: Endrocrinology & DM Schneider MC
city: Zerifin
country: Israel
facility: Shamir (Assaf Harofe) Medical Center
city: Puebla
country: Mexico
facility: Consultorio de Endocrinología y Pediatría
city: Lisboa
country: Portugal
facility: Hospital da Luz
city: Porto
country: Portugal
facility: Unidade Local de Saúde de Santo António, E.P.E
city: Porto
country: Portugal
facility: CUF-Porto
city: Halmstad
country: Sweden
facility: Hallands sjukhus Halmstad
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset Uppsala
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol & Weston NHS Foundation Trust
city: Leeds
country: United Kingdom
facility: Leeds Children's Hospital
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References: