A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH

Summary

This is a multicenter, Phase IIb, randomized, double blind, placebo-controlled study designed to evaluate the efficacy and safety of two Aramchol doses in subjects that are 18 to 75 years of age, with Non-Alcoholic Steatohepatitis (NASH) confirmed by liver biopsy performed in a period of 6 months before entering the study, with overweight or obesity and who are pre diabetic or type II diabetic.

Eligible subjects will be enrolled into three treatments arms: Aramchol 400 and 600 mg tablets and placebo tablets in ratio 2:2:1.

The subjects will be evaluated at study sites for 11 scheduled visits during one year (52 weeks). After completion of the study treatment period, the subjects will be followed for an additional period of 13 weeks without study medication (until visit 11 (week 65)).

Conditions

• Fatty Liver
• Non-Alcoholic Steatohepatitis
• Liver Diseases
• Liver Fibroses

Interventions

DRUG

Aramchol

Subjects will be administered Aramchol as follows: * One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol. * One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg. * Two tablet of Aramchol matching placebo. The tablets should be taken orally in the morning within 30 min after breakfast with a glass of water (250 ml). Subjects are allowed to omit study drugs up to 3 consecutive days during the study.

Sponsors & Collaborators

• Sharp

  collaborator INDUSTRY

• Diamond Pharma Services Regulatory Affairs Consultancy

  collaborator OTHER

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  collaborator OTHER

• ClinIntel

  collaborator INDUSTRY

• Itamar-Medical, Israel

  collaborator INDUSTRY

• One Way Liver OWL

  collaborator INDUSTRY

• Medical University of Graz

  collaborator OTHER

• Tel-Aviv Sourasky Medical Center

  collaborator OTHER_GOV

• DSG EDC

  collaborator UNKNOWN

• TransPerfect

  collaborator INDUSTRY

• Clinical Reference Laboratory

  collaborator INDUSTRY

• Galmed Research and Development, Ltd.

  lead INDUSTRY

Principal Investigators

• Vlad Ratziu, MD, PhD · Professor of Hepatology, Université Pierre et Marie Curie & Hospital Pitie Salpetriere Medical University, Paris.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-29

Primary Completion

2018-05-22

Completion

2018-05-22

FDA Drug

Yes

Countries

• United States
• Chile
• France
• Georgia
• Germany
• Hong Kong
• Israel
• Italy
• Lithuania
• Mexico
• Romania

Study Locations