MedTrace Logo

Measure Liver Fat Content After ISIS 301012 (Mipomersen) Administration

NCT00362180 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2016-10-21

Study results available
· View outcomes & findings →

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.

Conditions

  • Lipid 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

Interventions

DRUG

mipomersen

200 mg subcutaneous injections

DRUG

Placebo

subcutaneous injections

Sponsors & Collaborators

  • Ionis Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Kastle Therapeutics, LLC

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Genzyme, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2010-03-31
Completion
2010-09-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00362180 on ClinicalTrials.gov