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

GALMED Pharmaceuticals LTD.0 sites240 target enrollmentMay 31, 2016

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: GALMED Pharmaceuticals LTD.
Enrollment: 240
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 31, 2016

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GALMED Pharmaceuticals LTD.

Eligibility Criteria

Inclusion Criteria

•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 the following 3 criteria is needed for pre\-Diabetic: Fasting Plasma Glucose \> 100mg/dl (5\.5 mmol/l) or 2hPG following 75g OGTT \> 140 (7\.8 mmol/l) mg/dl or HbA1c \> 5\.7%.
•4\. Histologically proven Steatohepatitis on a diagnostic liver biopsy performed within 6 months before screening visit, confirmed by central laboratory reading of the slides (steatosis \> 5% \+ lobular inflammation, any ballooning, any amount).
•5\. Liver fat concentration 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\. Understanding the nature of the study and signature of the written informed consent.
•9\. Negative pregnancy test at study entry for females of child bearing potential.
•10\. Females of child bearing potential practicing reliable contraception throughout the study period (including oral contraceptives). If barrier methods are used, it is recommended to practice two methods (e.g. male condom \+ female diaphragm with spermicide). For country\-specific requirements (e.g. Germany) contraception failure rates (Pearl Index) should be under 1% in accordance with the recommendations of the CTFG Working Group on Contraception.

Exclusion Criteria

•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 induced liver disease) at the time of randomization.
•2\. Patients who have liver cirrhosis (CRN fibrosis score \=4\).
•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\. Patients with familial hypertriglyceridemia and familial hypercholesterolemia.
•6\. 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.
•7\. Patients with heart or brain pacemaker.
•8\. History of surgery within three months of screening which involved stent transplant or any other surgery which includes transplantation of metal devices (e.g. knee, hip etc.)
•9\. Weight loss of more than 5% within 6 months prior to randomization.
•10\. History of bariatric surgery within 5 years of liver biopsy.