A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Overweight; Obesity

Treatments: Other: Placebo; Drug: Semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04102189

2018-002431-18 (EudraCT Number)

NN9536-4451

U1111-1215-7560 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 201 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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201 participants in 2 patient groups, including a placebo group

Semaglutide

Experimental group

Description:

2.4 mg or maximum tolerated dose (MTD) injected subcutaneously (under the skin, s.c.) once weekly

Treatment:

Drug: Semaglutide

Placebo

Placebo Comparator group

Description:

Placebo injected s.c. once weekly .

Treatment:

Other: Placebo