A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Intervention: Semaglutide; Placebo
Intervention description: Participants will receive semaglutide s.c. once weekly for a dose escalation period of 16 weeks and a maintenance period of 52 weeks; Participants will receive semaglutide placebo s.c. once weekly for a total of 68 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Sponsor staff involved in the clinical trial is masked according to company standard procedures
Enrollment: 201.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

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