A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH (Aramcho
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)).
Study Start Date
Estimated Completion Date
- Drug: Aramchol
- Infectious Disease: Hepatitis
- Gastroenterology: Hepatology
- Endocrinology: Diabetes
- Pharmacy: Drug Trials,Stomach/GI
- Digestive System Diseases
- Fatty Liver
- Liver Diseases
Galmed Pharmaceuticals Ltd -- 005
Phase 2/Phase 3
Galmed Pharmaceuticals Ltd
1. Male or female age 18 to 75 years.
2. 25 ? BMI ?40 kg/m2 or waist circumference > 88 for women and > 102 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 or 2hPG
following 75g OGTT > 140 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 >3.5gm%, 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.
10. Females of child bearing potential practicing reliable contraception throughout the
study period (including oral contraceptives).
11. Hypertensive patients must be well controlled by stable dose of anti-hypertensive
medication for at least 2 months prior to screening (and the stable dose can be
maintained throughout the study).
12. Patients previously treated with vitamin E (>400IU/day),Polyunsaturated fatty acid
(>2g/day) or Ursodeoxycholic acid or fish oil can be included if drugs are stopped at
least 3 months prior to diagnostic liver biopsy and up to the end of study.
13. For patients with type II Diabetes, glycaemia must be controlled (Glycosylated
Hemoglobin A1C ? 9% while any HbA1C increment should not exceed 1% during 6 month
prior to enrollment). Treatments with Metformin, Sulfamides and Insulin are
authorized. Sulfamides and insulin are permitted if glycaemia is self-monitored by
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
2. Known Alcohol and/or any other drug abuse or dependence in the last five years.
3. 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.
4. 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.
5. Weight loss of more than 5% within 6 months prior to randomization.
6. History of bariatric surgery.
7. Uncontrolled blood pressure.
8. Non type II Diabetes Mellitus (type I, endocrinopathy, genetic syndromes etc.).
9. Patients with HIV.
10. Daily alcohol intake >20 g/day for women and 30 g/day for men.
11. Treatment with other anti-diabetic medications: DPP-4 inhibitors and GLP-1 receptor
agonists (such as Genuvia, Sitagliptin, Byetta [Incretin], etc.)
12. Metformin, Fibrates, Statins, Insulin, Sulfonilurea not provided on a stable dose in
the last 6 months.
13. Patients who are treated with Valproic acid, Tamoxifen, Methotraxete, Amiodaron.
14. Chronic antibiotic treatment (e.g. Rifaximin).
15. Homeopathic and/or Alternative treatments. Any treatment should be stopped before the
16. Uncontrolled hypothyroidism defined as Thyroid Stimulating Hormone >2X the upper
limit of normal (ULN). Thyroid dysfunction controlled for at least 6 months prior to
screening is permitted.
17. Patients with renal dysfunction eGFR< 40.
18. Unexplained serum creatine phosphokinase (CPK) >3X the upper limit of normal (ULN).
Patients with an intermittent CPK elevation may have the repeated measurement prior
to randomization a CPK retest > 3X ULN leads to exclusion.
18 Years to 75 Years
Accepts Healthy Volunteers
Study Locations and Contact Information (12)
|New York Medical College - New York, New York||29.6 miles||Ed Lebovics Dr||None||None|
|Mount Sinai - New York, New York||46.8 miles||Charissa Chang Dr||None||None|
|University of Virginia Medical Center - Charlottesville, Virginia||357.0 miles||Stephen Caldwell Prof||None||None|
|Wake Research - Raleigh, North Carolina||474.0 miles||Charles Barish Dr||None||None|
|Duke University Medical Center - Durham, North Carolina||474.7 miles||Manal AbdelmaleK Prof||None||None|
|Indiana University - Indianapolis, Indiana||686.4 miles||Samer Gawrieh Dr||None||None|
|San Antonio Military Medical Center - Fort Sam Houston, Texas||1,634.2 miles||Stephen A Harrison Prof||None||None|
|Texas Liver Institute San Antonio - San Antonio, Texas||1,634.2 miles||Fred Poordad Dr||None||None|
|Clinical Trials of Texas - San Antonio, Texas||1,635.9 miles||Douglas Denham Dr||None||None|
|Profile Institue for Clinical Research Inc - Chula Vista, California||2,470.8 miles||Elaine Watkins Dr||None||None|
|University of California Department of Medicine Division of Gastroenterology - San Diego, California||2,472.6 miles||Rohit Loomba Prof||None||None|
|Orange County Research Center - Tustin, California||2,476.5 miles||Joel M Neutel Dr||None||None|