Vinaya Simha, M.B.B.S., M.D.

Closed for Enrollment

• A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia Undergoing Lipid Apheresis Therapy (ODYSSEY ESCAPE) Rochester, Minn.

  This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effect of alirocumab in comparison with placebo on the frequency of LDL apheresis treatments in patients with HeFH undergoing LDL apheresis therapy.

• A Randomized, Double-Blind, Placebo-Controlled, With an Open Label Extension, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients With Familial Partial Lipodystrophy Rochester, Minn.

  The purpose of this study is to evaluate the efficacy and safety of volanesorsen (IONIS-APOCIIIRx) given for 52 weeks in patients with Familial Partial Lipodystrophy. Patients will then be allowed to continue in a 2 year Open Label Extension of the study.

• A Randomized, Double-Blinded, Placebo-Controlled Phase IIa Study to Assess the Efficacy and Safety of a Novel AstraZeneca Compound in Subjects with Non-Alcoholic Steatohepatitis (NASH) or Non-Alcoholic Fatty Liver Disease (NAFLD) Rochester, Minn.

  The purpose of this study is to assess a new drug to decrease liver fat in subjects with Non-Alcoholic Steatohepatitis or Non-Alcoholic Fatty Liver Disease.

• Genetic and Metabolic Basis of Familial Partial Lipodystrophy (FPL) Rochester, Minn.

  The purpose of this study is to find the gene mutations and metabolism dysfunctions that appear to cause the physical disorders of people who have Familial Partial Lipodystrophy.