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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1162-9171 | Other Identifier | WHO | |
| 2014-004454-34 | EudraCT Number |
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This trial is conducted in the United States of America. The aim of this trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of liraglutide in obese children aged 7 to 11 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 | For subcutaneous (s.c., under the skin) injection once daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events | From the time of first dosing and until completion of follow-up visit (59-108 days after first dosing) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the liraglutide concentration curve | From 0-24 hours at steady state following the last dose (49-91 days after first dosing) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Anaheim | California | 92801 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30653847 | Result | Mastrandrea LD, Witten L, Carlsson Petri KC, Hale PM, Hedman HK, Riesenberg RA. Liraglutide effects in a paediatric (7-11 y) population with obesity: A randomized, double-blind, placebo-controlled, short-term trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics. Pediatr Obes. 2019 May;14(5):e12495. doi: 10.1111/ijpo.12495. Epub 2019 Jan 17. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| placebo |
| Drug |
For subcutaneous (s.c., under the skin) injection once daily. |
|
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Novo Nordisk Investigational Site | Jacksonville | Florida | 32207 | United States |
| Novo Nordisk Investigational Site | Pensacola | Florida | 32504 | United States |
| Novo Nordisk Investigational Site | Atlanta | Georgia | 30331 | United States |
| Novo Nordisk Investigational Site | Buffalo | New York | 14203 | United States |
| Novo Nordisk Investigational Site | Mineola | New York | 11501 | United States |
| Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania | 15224 | United States |
| Novo Nordisk Investigational Site | Memphis | Tennessee | 38119 | United States |
| 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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