At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 38 enrolled
Drug / intervention
mipomersen +1 moredrug
Likely dose
mipomersen 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Apolipoprotein B(ApoB) Reduction by ISIS 301012 on Liver Triglyceride Content in Subjects With Varying Degrees of Hyperlipidemia
In Brief
A Phase 2 clinical trial evaluating mipomersen and Placebo for Lipid Metabolism, Inborn Errors and 13 related conditions. Completed, enrolled 38 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLipid Metabolism, Inborn Errors, Hyperlipidemias, Metabolic Diseases, Hypolipoproteinemia, Hypolipoproteinemias, Hypobetalipoproteinemias, Metabolism, Inborn Errors, Genetic Diseases, Inborn, Infant, Newborn, Diseases, Congenital Abnormalities, Metabolic Disorder, Hypercholesterolemia, Dyslipidemias, Lipid Metabolism Disorders
CountriesNetherlands
CollaboratorsIonis Pharmaceuticals, Inc.
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2006
First PostedAug 2006
Primary CompletionMar 2010
Study CompletionSep 2010
TodayJul 2026
First PostedAug 9, 2006
Enrollment StartJul 1, 2006
Primary CompletionMar 1, 2010
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 19.9 years ago
Interventions
mipomersendrug
200 mg subcutaneous injections
Placebodrug
subcutaneous injections