Measure Liver Fat Content After ISIS 301012 (Mipomersen) Administration
Lipid Metabolism, Inborn Errors, Hyperlipidemias, Metabolic Diseases
About this trial
This is an interventional treatment trial for Lipid Metabolism, Inborn Errors focused on measuring LDL-cholesterol, apoB-100, apoB-48, triglyceride, HeFH, FHBL
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
No Intervention
Experimental
Placebo Comparator
Cohort A: mipomersen
Cohort A: placebo
Cohort D: mipomersen
Cohort D: placebo
Cohort E: mipomersen
Cohort E: placebo
Cohort F: no intervention
Cohort G: mipomersen
Cohort G: placebo followed by mipomersen
Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks. Injections were given subcutaneously (sc) on days 1, 4, 8, 11, 15 and 22.
Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks. Injections were given subcutaneously (sc) on days 1, 4, 8, 11, 15 and 22.
Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks. Injections were given subcutaneously (sc) on days 1, 4, 8, 11, 15 and 22.
Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of placebo over the course of 4 weeks. Injections were given subcutaneously (sc) on days 1, 4, 8, 11, 15 and 22.
Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.