Measure Liver Fat Content After ISIS 301012 (Mipomersen) Administration

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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 to enroll subject groups with varying degrees of risk, the study has included multiple cohorts (Cohorts A-G). Additions and removal of cohorts has been accomplished with protocol amendments.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kastle Therapeutics, LLC
• Collaborator: Ionis Pharmaceuticals, Inc.
• Treatments: Mipomersen

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.