Clinical trial NCT04102189: A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity
Official title: Effect and Safety of Semaglutide 2.4 mg Once Weekly on Weight Management in Adolescents With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overweight
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-09-25
Enrollment: 201
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will look at the change in teenagers' body weight from the start to the end of the study. This is to compare the effect on body weight in teenagers taking semaglutide (a new medicine) and teenagers taking "dummy" medicine. The teenagers in the study and their parents will also have talks with study staff about healthy food choices, how to be more physically active and what they can do to help the teenagers lose weight. The teenagers will either get semaglutide or "dummy" medicine - which treatment is decided by chance. The teenagers will take 1 injection every week, on the same day of the week for about 15 months. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The teenagers will have 17 clinic visits, will have blood samples taken and will have to complete questionnaires and keep a diary. All this will be explained before study start.


Eligibility criteria: Inclusion Criteria:

* Informed consent of parent(s) or legally acceptable representative of subject and child assent, as appropriate obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male or female, ages 12 to below 18 years at the time of signing informed consent
* BMI equal to or above 95th percentile OR equal to or above 85th percentile (on gender and age-specific growth charts (CDC.gov)) with 1 or more weight related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or type 2 diabetes
* History of at least one self-reported unsuccessful dietary effort to lose weight

For subjects with type 2 diabetes at screening the following inclusion criteria apply in addition:

- HbA1c equal to or below 10.0% (86 mmol/mol) as measured by central laboratory at screening

Exclusion Criteria:

* Prepubertal subjects (Tanner stage 1)
* History of type 1 diabetes
* A self-reported (or by parent(s)/legally acceptable representative where applicable) change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records
* Subjects with secondary causes of obesity (i.e., hypothalamic, monogenic or endocrine causes)
* For subjects with type 2 diabetes only: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Primary outcomes:
measure: Change in Body Mass Index (BMI) (Percentage [%])
timeFrame: Baseline (week 0), week 68
Secondary outcomes:
measure: Percentage of Participants Achieving Greater Than or Equal to (>=) 5% Reduction of Body Weight (Yes/no)
timeFrame: At week 68
measure: Change in Body Weight (Kilograms [kg])
timeFrame: Baseline (week 0), week 68
measure: Change in Body Weight (%)
timeFrame: Baseline (week 0), week 68
measure: Percentage of Participants Achieving >=10% Reduction of Body Weight (Yes/no)
timeFrame: At week 68
measure: Percentage of Participants Achieving >=15% Reduction of Body Weight (Yes/no)
timeFrame: At week 68
measure: Percentage of Participants Achieving >=20% Reduction of Body Weight (Yes/no)
timeFrame: At week 68
measure: Change in BMI Percentage of the 95th Percentile on Gender and Age-specific Growth Charts (CDC.Gov [CDC: {Centers for Disease Control and Prevention}])
timeFrame: Baseline (week 0), week 68
measure: Percentage of Participants Achieving Improvement in Weight Category (Yes/no)
timeFrame: At week 68
measure: Change in BMI (Standard Deviation Score [SDS])
timeFrame: Baseline (week 0), week 68
measure: Change in BMI (Kilograms Per Meter Square [kg/m^2])
timeFrame: Baseline (week 0), week 68
measure: Change in Waist Circumference
timeFrame: Baseline (week 0), week 68
measure: Percentage of Participants Achieving >=5% Reduction of BMI (Yes/no)
timeFrame: At week 68
measure: Change in Systolic Blood Pressure
timeFrame: Baseline (week 0), week 68
measure: Change in Diastolic Blood Pressure
timeFrame: Baseline (week 0), week 68
measure: Change in Glycated Haemoglobin (HbA1c) (%)
timeFrame: Baseline (week 0), week 68
measure: Change in HbA1c (Millimoles Per Mole [mmol/Mol])
timeFrame: Baseline (week 0), week 68
measure: Change in Fasting Plasma Glucose (Millimoles Per Liter [mmol/L])
timeFrame: Baseline (week 0), week 68
measure: Change in Fasting Plasma Glucose (Milligrams Per Deciliter [mg/dL])
timeFrame: Baseline (week 0), week 68
measure: Change in Fasting Insulin (Picomoles Per Liter [Pmol/L]): Ratio to Baseline
timeFrame: Baseline (week 0), week 68
measure: Change in Fasting Insulin (Milli International Units Per Milliliter [mIU/mL]): Ratio to Baseline
timeFrame: Baseline (week 0), week 68
measure: Change in Total Cholesterol (mmol/L): Ratio to Baseline
timeFrame: Baseline (week 0), week 68
measure: Change in Total Cholesterol (mg/dL): Ratio to Baseline
timeFrame: Baseline (week 0), week 68
measure: Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L): Ratio to Baseline
timeFrame: Baseline (week 0), week 68:
measure: Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL): Ratio to Baseline
timeFrame: Baseline (week 0), week 68
measure: Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L): Ratio to Baseline
timeFrame: Baseline (week 0), week 68
measure: Change in LDL Cholesterol (mg/dL): Ratio to Baseline
timeFrame: Baseline (week 0), week 68:
measure: Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L): Ratio to Baseline
timeFrame: Baseline (week 0), week 68
measure: Change in VLDL Cholesterol (mg/dL): Ratio to Baseline
timeFrame: Baseline (week 0), week 68
measure: Change in Triglycerides (mmol/L): Ratio to Baseline
timeFrame: Baseline (week 0), week 68
measure: Change in Triglycerides (mg/dL): Ratio to Baseline
timeFrame: Baseline (week 0), week 68
measure: Change in Alanine Aminotransferase (ALT): Ratio to Baseline
timeFrame: Baseline (week 0), week 68
measure: Number of Treatment-emergent Adverse Events (TEAEs)
timeFrame: From baseline (week 0) to week 75
measure: Number of Treatment-emergent Serious Adverse Events (SAEs)
timeFrame: From baseline (week 0) to week 75
measure: Change in Pulse
timeFrame: Baseline (week 0), week 68
measure: Change in Amylase: Ratio to Baseline
timeFrame: Baseline (week 0), week 68
measure: Change in Lipase: Ratio to Baseline
timeFrame: Baseline (week 0), week 68
measure: Change in Calcitonin: Ratio to Baseline
timeFrame: Baseline (week 0), week 68
Other outcomes:
Locations:
city: Meridian
country: United States
facility: Novo Nordisk Investigational Site
state: Idaho
city: Baltimore
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Boston
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Minneapolis
country: United States
facility: Novo Nordisk Investigational Site
state: Minnesota
city: Buffalo
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Raleigh
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Fargo
country: United States
facility: Novo Nordisk Investigational Site
state: North Dakota
city: Columbus
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Pittsburgh
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Rapid City
country: United States
facility: Novo Nordisk Investigational Site
state: South Dakota
city: Marshfield
country: United States
facility: Novo Nordisk Investigational Site
state: Wisconsin
city: Saint Stefan
country: Austria
facility: Novo Nordisk Investigational Site
city: Salzburg
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Brussel
country: Belgium
facility: Novo Nordisk Investigational Site
city: Bruxelles
country: Belgium
facility: Novo Nordisk Investigational Site
city: Edegem
country: Belgium
facility: Novo Nordisk Investigational Site
city: Leuven
country: Belgium
facility: Novo Nordisk Investigational Site
city: Rijeka
country: Croatia
facility: Novo Nordisk Investigational Site
city: Zagreb
country: Croatia
facility: Novo Nordisk Investigational Site
city: Zagreb
country: Croatia
facility: Novo Nordisk Investigational Site
city: Dublin
country: Ireland
facility: Novo Nordisk Investigational Site
state: Leinster
city: Puebla
country: Mexico
facility: Novo Nordisk Investigational Site
city: Izhevsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Rostov-on-Don
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Tomsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Rotherham
country: United Kingdom
facility: Novo Nordisk Investigational Site
state: South Yorkshire
city: Birmingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bristol
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sheffield
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Southampton
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: Weghuber D, Barrett T, Barrientos-Perez M, Gies I, Hesse D, Jeppesen OK, Kelly AS, Mastrandrea LD, Sorrig R, Arslanian S; STEP TEENS Investigators. Once-Weekly Semaglutide in Adolescents with Obesity. N Engl J Med. 2022 Dec 15;387(24):2245-2257. doi: 10.1056/NEJMoa2208601. Epub 2022 Nov 2.
citation: Cuda S, Censani M. Progress in pediatric obesity: new and advanced therapies. Curr Opin Pediatr. 2022 Aug 1;34(4):407-413. doi: 10.1097/MOP.0000000000001150. Epub 2022 Jul 5.