A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability and Pharmacokinetics of Liraglutide in Obese Adolescent Subjects Aged 12 to 17 Years

NCT01789086 | Completed Phase 1

• 3 other identifiers: NN8022-39672012-000038-20U1111-1126-8119
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Europe. The purpose of the trial is to assess safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of liraglutide in obese adolescent subjects aged 12 to 17 years.

Conditions

Metabolism and Nutrition Disorder; Obesity

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAEs)

  From the time of first dosing (Day 0) and until completion of follow-up visit (up to 6 weeks' treatment and 5-14 days subsequent follow-up period)

Secondary Outcomes (6)

• Incidence of liraglutide antibody

  At follow-up (up to 6 weeks' treatment and 5-14 days subsequent follow-up period)

• At steady state at each dose step: C-trough

  After 7, 14, 21, 28 and 35 days of treatment

• At steady-state: model-derived area under the liraglutide concentration curve over the dosing

  Last dose day, after up to 6 weeks' treatment

• At steady-state: model-derived t½ (terminal half-life)

  Last dose day, after up to 6 weeks' treatment

• At steady-state: model-derived CL/F (apparent clearance)

  Last dose day, after up to 6 weeks' treatment

Study Arms (2)

Liraglutide

EXPERIMENTAL

Drug: liraglutide

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

liraglutide DRUG

Administered subcutaneously (s.c., under skin) for 5-6 weeks. Initial dose of 0.6 mg/day. The dose will be escalated by 0.6 mg/day in weekly steps to a maximum of 3.0 mg/day

Liraglutide

placebo DRUG

Administered subcutaneously (s.c., under skin) for 5-6 weeks. Initial dose of 0.6 mg/day. The dose will be escalated by 0.6 mg/day in weekly steps to a maximum of 3.0 mg/day

Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects with Tanner stage 2-5 pubertal development at time of randomisation
• Body Mass Index (BMI) corresponding to 30 kg/m\^2 or above for adults by international cut-off points and 45 kg/m\^2 or below and equal to or above 95th percentile for age and gender
• Fasting plasma glucose below 7.0 mmol/L (126 mg/dL) (central laboratory analysis)

You may not qualify if:

• Subjects with clinically diagnosed secondary causes of childhood obesity such as chromosomal abnormalities (e.g. Turner syndrome), syndromic obesity (e.g. Prader Willi syndrome) or endocrinologic disorders (e.g. Cushing Syndrome)
• Subjects with confirmed diagnosis of bulimia
• Subjects with Tanner stage 1 development (prepubertal)
• Diagnosis of type 1 or type 2 diabetes mellitus as judged by the investigator
• Previous treatment with a GLP-1 (glucagon-like peptide 1) receptor agonists (e.g. exenatide or liraglutide or other), DPP-4 (dipeptidyl peptidase-4) inhibitors, orlistat or other weight lowering medication, any antipsychotic medication or systemic corticosteroids within the last 3 months
• Currently using or have used within 3 months before screening for this trial: any systemic treatment that in the opinion of the investigator interferes with PK (pharmacokinetic), PD (pharmacodynamic) and safety endpoints
• Surgical treatment for obesity
• Past or current chronic or idiopathic pancreatitis, or any of the following: -amylase or lipase above 2 times UNR (upper normal range), -triglycerides above 500 mg/dL, -calcium above UNR, -history of gallstones (not treated by cholecystectomy)
• Uncontrolled treated or untreated hypertension 99th percentile for age and gender in children
• History of major depressive disorder or history of other severe psychiatric disorders (e.g. schizophrenia or bipolar disorder) that could in the opinion of the investigator interfere with trial compliance or subject safety
• Subjects with a history of suicide attempts or history of any suicidal behaviour within the past month before entry into the trial

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Hanover, 30173, Germany

Location

Related Publications (1)

• Danne T, Biester T, Kapitzke K, Jacobsen SH, Jacobsen LV, Petri KCC, Hale PM, Kordonouri O. Liraglutide in an Adolescent Population with Obesity: A Randomized, Double-Blind, Placebo-Controlled 5-Week Trial to Assess Safety, Tolerability, and Pharmacokinetics of Liraglutide in Adolescents Aged 12-17 Years. J Pediatr. 2017 Feb;181:146-153.e3. doi: 10.1016/j.jpeds.2016.10.076. Epub 2016 Dec 13.

  PMID: 27979579 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Nutrition Disorders; Obesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Overweight; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: February 11, 2013
• Study Start: February 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 22, 2016

Record last verified: 2016-12

Locations

DE (1)