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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000038-20 | EudraCT Number | ||
| U1111-1126-8119 | Other Identifier | WHO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Hanover | 30173 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27979579 | Result | 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. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| 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 |
|
| 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 |
| At steady-state: model-derived V/F (apparent volume of distribution) | Last dose day, after up to 6 weeks' treatment |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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