Overweight Obesity MedDRA version: 20.0 Level: PT Classification code 10033307 Term: Overweight System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: Semaglutide B 1.0 mg/mL PDS290
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: semaglutide
CAS Number: 910463-68-2
Other descriptive name: SEMAGLUTIDE
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion 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 less than 18 years at the time of signing informed consent - BMI equal to or above 95th percentile (on gender and age-specific growth charts (CDC.gov)) OR equal to or above 85th percentile (on gender and age-specific growth charts (CDC.gov)) with up to 1 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 Are the trial subjects under 18? yes Number of subjects for this age range: 192 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of semaglutide subcutaneous once-weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity on weight management in adolescents (ages 12 to less than 18 years) with overweight or obesity.;Primary end point(s): Change in BMI from baseline;Timepoint(s) of evaluation of this end point: Week 0 to week 68;Secondary Objective: 1. To compare the effect of semaglutide subcutaneous once weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in adolescents (ages 12 to less than 18 years) with overweight or obesity on: - Cardiovascular risk factors - Glucose metabolism 2. To compare the safety and tolerability of semaglutide subcutaneous once weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in adolescents with overweight or obesity | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Subjects achieving equal to or above 5% reduction of body weight from baseline (yes/no);Timepoint(s) of evaluation of this end point: Week 0 to week 68 | — |
Countries
Austria, Belgium, Croatia, European Union, Ireland, Mexico, Russian Federation, United Kingdom, United States
Contacts
Public ContactClinical Disclosure (1452)
Novo Nordisk A/S
Outcome results
None listed