Status:
COMPLETED
A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Overweight
Obesity
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2022
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT04102189
Start Date
October 7 2019
End Date
March 28 2022
Last Update
December 11 2025
Active Locations (51)
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1
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California, United States, 90027
2
Solaris Clinical Research
Meridian, Idaho, United States, 83646
3
Pennington Biomed Res Ctr
Baton Rouge, Louisiana, United States, 70808-4124
4
DelRicht Research
Gretna, Louisiana, United States, 70053