A Phase IIb, double blind, randomized controlled clinical trial to evaluatethe efficacy and safety of two Aramchol doses versus placebo in patientswith Non-Alcoholic- Steatohepatitis (NASH). - ARREST

GALMED PHARMACEUTICALS LTD.0 sites240 target enrollmentSeptember 9, 2021

Overview

No summary available.

Registry

who.int

Start Date

September 9, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Male or female age 18 to 75 years.
•2\. 25 \= BMI \=40 kg/m2 or waist circumference \> 88 \<200 cm for women and \> 102 \<200 cm for men.
•3\. Known type II Diabetes Mellitus or pre\-Diabetes according to American Diabetes Association (one of three needed): Fasting Plasma Glucose \> 100mg/dl (5\.5 mmole/l) or 2hPG following 75g OGTT \> 140
•(7\.8 mmole/l) mg/dl or HbA1C \> 5\.7%.
•4\. Histologically proven Steatohepatitis on a diagnostic liver biopsy performed within 6 months before randomization, confirmed by central laboratory reading of the slides (steatosis \> 5%\+ lobular inflammation, any ballooning, any amount).
•5\. Fat concentration in the liver of 5\.5% or more as measured by NMRS.
•6\. Biopsies with an activity NAS score of 4 or more.
•7\. Normal synthetic liver function (serum albumin \>3\.5g/l, INR 0\.8\-1\.3\).
•8\. Signature of the written informed consent.
•9\. Negative pregnancy test at study entry for females of child bearing potential.

•1\. Patients with other active (acute or chronic) liver disease other than NASH (e.g. viral hepatitis, genetic hemochromatosis, Wilson disease,
•alpha 1antitripsin deficiency, alcohol liver disease, drug induces liver disease) at the time of randomization.
•2\. Patients who have liver cirrhosis.
•3\. Known Alcohol and/or any other drug abuse or dependence in the last five years.
•4\. Known history or presence of clinically significant cardiovascular, hepatic other than NASH, gastrointestinal, metabolic other than Diabetes
•Mellitus, neurologic, pulmonary, endocrine, psychiatric, neoplastic disorder or nephrotic syndrome.
•5\. History or presence of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs including bile salt metabolism (e.g. inflammatory bowel disease (IDB);
•previous intestinal (ileal or colonic) operation; chronic pancreatic; celiac disease or previous vagotomy.
•6\. Patients with heart or brain pacemaker.
•7\. History of surgery during the last three month before screening which involved stent transplant or any other surgery which includes transplantation of metal devices (e.g. knee, hip etc.).