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Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity

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ClinicalTrials.gov Identifier: NCT02918279
Recruitment Status : Active, not recruiting
First Posted : September 28, 2016
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted globally. The aim of this trial is to investigate the effect of liraglutide for weight management in pubertal adolescent subjects with obesity.

Condition or disease Intervention/treatment Phase
Metabolism and Nutrition Disorder Obesity Drug: Liraglutide Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity. 56-week, Double-blind, Randomised, Parallel-group, Placebo-controlled Multi-national Trial Followed by a 26-week Period Off Study-drug
Actual Study Start Date : September 29, 2016
Estimated Primary Completion Date : February 7, 2019
Estimated Study Completion Date : August 8, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Liraglutide Drug: Liraglutide
Administered once daily subcutaneously (s.c., under the skin)

Placebo Comparator: Placebo Drug: Placebo
Administered once daily subcutaneously (s.c., under the skin)




Primary Outcome Measures :
  1. Change in body mass index (BMI) standard deviation score [ Time Frame: Week 0, Week 56 ]

Secondary Outcome Measures :
  1. Percent of subjects achieving equal to or above 5% reduction in baseline BMI [ Time Frame: At week 56 ]
  2. Percent of subjects achieving equal to or above 10% reduction in baseline BMI [ Time Frame: At week 56 ]
  3. Change in body mass index (BMI) [ Time Frame: Week 0, Week 56 ]
  4. Change in body weight (kilogram [kg], pounds [lb] [ Time Frame: Week 0, Week 56 ]
  5. Change in body weight (percent [%]) [ Time Frame: Week 0, Week 56 ]
  6. Change in systolic and diastolic blood pressure [ Time Frame: Week 0, Week 56 ]
  7. Change in glucose metabolism: glycosylated haemoglobin (HbA1c) [ Time Frame: Week 0, Week 56 ]
  8. Change in fasting plasma glucose [ Time Frame: Week 0, Week 56 ]
  9. Change in number of treatment emergent adverse events [ Time Frame: Week 0, Week 56 ]


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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent 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, age 12 to less than 18 years at the time of signing informed consent and less than 18 years at date of randomisation
  • BMI corresponding to equal to or above 30 kg/m^2 for adults by international cut-off points and equal or above the 95th percentile for age and sex (for diagnosis of obesity)
  • Stable body weight during the previous 90 days before screening V2 (below 5 kg self-reported weight change)
  • History of failing to lose sufficient weight with lifestyle modification as judged by the investigator and documented in subject's medical record

Exclusion Criteria:

  • Pre-pubertal subjects (Tanner stage 1) at screening V2
  • Type 1 diabetes mellitus (T1DM)
  • Family or personal history of multiple endocrine neoplasia type 2 (MEN2)
  • Medullary thyroid carcinoma (MTC)
  • History of pancreatitis (acute or chronic)
  • Subjects with secondary causes of obesity (i.e., hypothalamic, genetic or endocrine causes)
  • Treatment with medications within 90 days before screening V2 that, based on the investigator's judgement, may cause significant weight change. This should also include treatment with any of the following medications: pramlintide, orlistat, zonisamide, topiramate, lorcaserin, phenteremine, bupropion, naltrexone, glucagon-like peptide-1 (GLP-1) receptor agonists, or metformin (used as treatment for obesity)
  • Anti-diabetic treatment other than metformin
  • History of major depressive disorder within 2 years before screening V2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918279


  Show 33 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR) Novo Nordisk A/S

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02918279     History of Changes
Other Study ID Numbers: NN8022-4180
2014-004353-14 ( EudraCT Number )
U1111-1162-7101 ( Other Identifier: WHO )
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Obesity
Nutrition Disorders
Overnutrition
Overweight
Body Weight
Signs and Symptoms
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists