CLINICAL TRIALS PROFILE FOR ARAMCHOL

Clinical Trials for Aramchol

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00776841 ↗	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
NCT01094158 ↗	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.
NCT01094158 ↗	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.
NCT01094158 ↗	Study of Aramchol in Patients With Fatty Liver Disease or Nonalcoholic Steatohepatitis	Completed	Hillel Yaffe Medical Center	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.
NCT01094158 ↗	Study of Aramchol in Patients With Fatty Liver Disease or Nonalcoholic Steatohepatitis	Completed	Holy Family Hospital, Nazareth, 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.
NCT01094158 ↗	Study of Aramchol in Patients With Fatty Liver Disease or Nonalcoholic Steatohepatitis	Completed	Kaplan Hospital ,Rehovot,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.
NCT01094158 ↗	Study of Aramchol in Patients With Fatty Liver Disease or Nonalcoholic Steatohepatitis	Completed	Meir Medical Center	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.

Clinical Trial Conditions for Aramchol

Condition Name

Condition Name for
Intervention	Trials
Healthy	3
Healthy Volunteers	2
NASH	1
Non-Alcoholic Fatty Liver Disease	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Liver Diseases	4
Fatty Liver	4
Non-alcoholic Fatty Liver Disease	4
Gallstones	1

Clinical Trial Locations for Aramchol

Trials by Country

Trials by Country for
Location	Trials
United States	11
Israel	4
United Kingdom	3
Mexico	2
Chile	1

Trials by US State

Trials by US State for
Location	Trials
California	3
Florida	2
Texas	2
Virginia	1
North Carolina	1

Clinical Trial Progress for Aramchol

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	4
Phase 1	7

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	9
Recruiting	1
Terminated	1

Clinical Trial Sponsors for Aramchol

Sponsor Name

Sponsor Name for
Sponsor	Trials
Galmed Pharmaceuticals Ltd	7
Diamond Pharma Services Regulatory Affairs Consultancy	4
Galmed Research and Development, Ltd.	3

Sponsor Type

Sponsor Type for
Sponsor	Trials
Other	40
Industry	17