CompletedPhase 2

Measure Liver Fat Content After ISIS 301012 (Mipomersen) Administration

Netherlands38 participantsStarted 2006-07

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change From Baseline in Liver Triglyceride (TG) Content As Measured by Magnetic Resonance Spectroscopy (MRS)

Timeframe: Baseline, Day 26, Day 99

Trial details

NCT IDNCT00362180

SponsorKastle Therapeutics, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-03

Results submitted2013-02-25

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