A research study on how well liraglutide works in children with obesity
- Conditions
- ObesityMedDRA version: 20.0Level: PTClassification code: 10029883Term: Obesity Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- CTIS2023-508504-38-00
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 82
Informed consent of parent(s) or legally acceptable representative of subject and child assent, as age-appropriate, obtained before any trial-related activities for the Main phase as well as for the Extension phase of the trial. 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, aged 6 to <12 years at the time of signing informed consent, Tanner stage 1-5 pubertal development at the time of signing informed consent, BMI =95th percentile, on gender and age-specific growth charts (CDC.gov), History of failing to lose sufficient weight with lifestyle modification as judged by the investigator, For T2D Haemoglobin A1c (HbA1c) =10.0% (86 mmol/mol) as measured by central laboratory at screening
Nothing written about Key Excl.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effect of liraglutide 3.0 mg s.c. once daily versus placebo on weight <br>management in children aged 6 to <12 years with obesity;Secondary Objective: To compare the effect of liraglutide 3.0 mg s.c. once daily versus placebo in children aged 6 to <12 years with obesity on: •Cardiovascular risk factors •Glucose metabolism, To evaluate the safety and tolerability of liraglutide 3.0 mg s.c. once daily versus placebo in children aged 6 to <12 years with obesity;Primary end point(s): Relative change in BMI, from basekline (week 0) to week 56, in Percent
- Secondary Outcome Measures
Name Time Method