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This study will assess safety, tolerability, and effect of LCQ908 on blood lipids in patients with severe hypertriglyceridemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCQ908 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCQ908 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting and postprandial plasma triglycerides | baseline and 3 weeks after initiation of each dose level (a test meal will be served at baseline and on Day 21 of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood concentration to characterize LCQ908 kinetics | serial blood samples will be collected from all patients enrolled in the study on Day 21 of treatment with each dose | |
| Different blood lipid biomarkers (such as phospholipids, apolipoproteins, and free fatty acids) |
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Inclusion Criteria:
Exclusion Criteria:
Patients with:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Québec | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25889044 | Derived | Meyers CD, Tremblay K, Amer A, Chen J, Jiang L, Gaudet D. Effect of the DGAT1 inhibitor pradigastat on triglyceride and apoB48 levels in patients with familial chylomicronemia syndrome. Lipids Health Dis. 2015 Feb 18;14:8. doi: 10.1186/s12944-015-0006-5. |
| Label | URL |
|---|---|
| Results for CLCQ908A2212 from the Novartis Clinical Trials website | View source |
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| ID | Term |
|---|---|
| D006951 | Hyperlipoproteinemias |
| D008072 | Hyperlipoproteinemia Type I |
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C000594809 | pradigastat |
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|
| after 3 weeks of treatment with each dose |
| D009750 |
| Nutritional and Metabolic Diseases |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |