A Phase 1 Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers
Completed
Galmed Medical Reserch
Phase 1
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single and Multiple-Dose
Study of Aramchol in Healthy Male Volunteers.
Primary Objectives:
1. To assess and characterize the safety and tolerability of Aramchol in 16 healthy male
subjects at single doses ranging between 30 and 900 mg (Part A) and in 30 overweight,
mildly hypercholesterolemic, otherwise healthy male subjects receiving multiple doses
(Part B)
2. To assess the pharmacokinetics of Aramchol at the administered doses
Study of Aramchol in Patients With Fatty Liver Disease or Nonalcoholic Steatohepatitis
Completed
Beilinson Hospital, Petach Tikva,Israel
Phase 2
Primary purpose: Compare the changes in liver triglycerides concentration in the Aramchol
versus the placebo arm following three month treatment.
Secondary purpose: Comparing liver enzymes, markers of endothelial dysfunction, insulin
resistance, SCD1 activity and cholesterol synthesis and lipid levels, between the Aramchol
and the placebo arms.
Study of Aramchol in Patients With Fatty Liver Disease or Nonalcoholic Steatohepatitis
Completed
Hadassah Medical Organization
Phase 2
Primary purpose: Compare the changes in liver triglycerides concentration in the Aramchol
versus the placebo arm following three month treatment.
Secondary purpose: Comparing liver enzymes, markers of endothelial dysfunction, insulin
resistance, SCD1 activity and cholesterol synthesis and lipid levels, between the Aramchol
and the placebo arms.
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