A Study to Assess ARI-3037MO on Hepatic Fat Metabolism in Patients With Dysglycemia and Evidence of Hepatic Steatosis

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective To investigate the effect of a 24-week, twice daily dosing regimen of ARI-3037MO compared to placebo on plasma triglyceride (TG) levels, liver enzymes and hepatic fat content in patients with dysglycemia and hepatic steatosis due to nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH). Secondary Objective To investigate the safety and tolerability of a 24-week, twice daily dosing regimen of ARI-3037MO compared to placebo in patients with dysglycemia and evidence of NAFLD or NASH.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arisaph Pharmaceuticals Inc

Criteria

Inclusion Criteria:

1. Male and female patients ≥ 18 years of age at study entry

2. Female patients must be of nonchildbearing potential

3. Have a stable diet and agree to maintain this diet throughout the study

4. Have not gained or lost ≥ 10 lbs (4.5 kg) of body weight within 6months prior to Screening Visit 1

5. Have a body mass index (BMI) between 28 and 45 kg.m-2, inclusive

6. Have elevated alanine aminotransferase (ALT) levels. For men: 50 IU/L to 250 IU/L, inclusive. For women: 40 IU/L to 240 IU/L, inclusive.

7. Have HbA1c of < 9.5

8. Have a intrahepatic fat content of ≥ 10% confirmed by liver MRI

9. If taking antidiabetic therapies (excluding thiazolidines as per exclusion Criterion No. 13), i.e., metformin, sulfonylureas, dipeptidyl peptidase-4 inhibitors, insulin; must be on a stable dose for at least 3months prior to Screening Visit 1. Similarly, if taking lipid lowering therapies; must be on a stable dose for at least 3 months prior to Screening Visit 1.

10. Understands the study requirements and the treatment procedures, is willing to comply with all protocol-required evaluations and provides written informed consent before any study specific tests or procedures are performed

Exclusion Criteria:

1. A history of hepatic disease such as chronic hepatitis C virus or concurrent active hepatitis B virus (i.e., serum positive for hepatitis B surface antigen)

2. Autoimmune hepatitis

3. Primary biliary cirrhosis

4. Sclerosing cholangitis

5. Hereditary hemochromatosis

6. History of chronic / repeat blood transfusion (i.e., ≥ 20 units of blood)

7. Alpha-1 anti-trypsin deficiency

8. Wilson's disease

9. Thyroid disease

10. Bariatric surgery within 5 years prior to Screening Visit 1

11. Hepatic disease due to substance abuse

12. Have any concurrent disease or condition not listed above that, in the opinion of the PI, would make the patient unsuitable for participation in the study

13. Currently taking thiazolidines (glitazone therapy, i.e., Rosiglitazone, Pioglitazone)

14. Liver biopsy in the past 90 days with negative results for cirrhosis and steatosis

15. No evidence of hepatic decompensation or elevated serum bilirubin > 1.5 times the upper limit of normal

16. Estimated glomerular filtration rate < 60 mL/min according to the Modification of Diet in Renal Disease equation

17. Known substance abuse

18. Current smoker or a history of smoking (> 10 cigarettes, > 3 cigars or > 3 pipes/day)

19. Current consumption of > 3 units of alcohol per day (> 21 units per week) for men and > 2 units of alcohol per day (> 14 units per week) for women

20. Currently participating in another clinical study