Status:
COMPLETED
Measure Liver Fat Content After ISIS 301012 (Mipomersen) Administration
Lead Sponsor:
Kastle Therapeutics, LLC
Collaborating Sponsors:
Ionis Pharmaceuticals, Inc.
Conditions:
Lipid Metabolism, Inborn Errors
Hyperlipidemias
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will assess what, if any, effect that ISIS 301012 (mipomersen) has on liver triglyceride content in multiple groups of subjects with varying degrees of risk for hepatic steatosis. In order ...
Detailed Description
This was a randomized, double-blind, placebo-controlled study to measure the effect of treatment with mipomersen on liver triglyceride (TG) content in patients with varying degrees of hyperlipidemia a...
Eligibility Criteria
Inclusion
- Group A - are healthy subjects
- Group D - has impaired fasting glucose and mixed dyslipidemia
- Group E - has a diagnosis of Heterozygous Familial Hypercholesterolemia (HeFH) and on stable lipid-lowering therapy for 3 months
- Group F - has a diagnosis of Familial Hypobetalipoproteinemia (FHBL)
- Group G - has a diagnosis of Diabetes and hypercholesterolemia
Exclusion
- Medical, surgical, laboratory or other conditions which in the judgment of the Physician Investigator would make the subject unsuitable for enrollment, or potentially interfere with subject participation or completion of the study.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00362180
Start Date
July 1 2006
End Date
September 1 2010
Last Update
October 21 2016
Active Locations (1)
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1
Amsterdam, Netherlands, 1105 AZ