A Randomized, Double-Blind, Placebo Controlled Study to Assess the Efficacy and Safety of SNP-610 for the Treatment of Patients With Non-alcoholic Steatohepatitis

• Status: Not yet recruiting
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to compare the changes in serum ALT level among patients with non-alcoholic steatohepatitis (NASH) following 3-month treatment of 800 mg SNP-610 or the placebo. The secondary objectives will be to compare the changes in liver fat fraction, other liver function tests, cytokeratin-18 (CK-18) fragment level and adverse event / serious adverse event rates among the interventional and placebo arms.

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

Details

• Lead Sponsor: Sinew Pharma Inc.

Criteria

Inclusion Criteria:

1. Age ≥ 20 years

2. Body weight ≥ 54 kg

3. Diagnosis of non-alcoholic steatohepatitis (NASH) as evidenced by imaging or other diagnostic assessments. Subject should have documented liver fat content ≥ 10.0 % as measured by MRI method prior to study drug administration.

4. Alanine aminotransferase (ALT) levels ≥ 2.0x upper limit of normal (ULN) on at least two occasions, seven or more days apart, prior to study drug administration

5. Have adequate organ functions as defined by the following examinations prior to the start of study treatment:

1. Hematology: Hemoglobin ≥ 9 g/dL, a platelet count ≥ 100 x 10^9/L, and a white blood cell count ≥ 3.0 x 10^9/L

2. Renal: creatinine clearance ≥ 90 mL/min (by Cockcroft-Gault equation), serum uric acid < 9.0 mg/dL

6. Able to provide written informed consent, and understand and comply with the requirements of the study

Exclusion Criteria:

1. Decompensated or severe liver disease as evidenced by one or more of the following:

1. Confirmed cirrhosis or suspicion of cirrhosis

2. Liver transplant

3. Liver malignancy

4. Ascites

5. Bilirubin >2 x ULN, or ALT or AST > 10 x ULN

6. Acute or chronic hepatitis A, B, C, HIV, or other liver diseases affecting liver function.

Patients with cysts, hemangiomas, or similar abnormalities, are accepted.

2. History or presence of alcohol abuse, defined as consumption of more than 210 mL of alcohol per week (the equivalent of 14 glasses of 120-mL wine or 14 cans of 350-mL beer), or other substance abuse within the prior two years

3. Subjects who are unable to undergo an MRI scan.

4. Subjects have electronically, magnetically and mechanically activated implanted devices, including but not limited to automatic cardioverter defibrillators, cardiac pacemakers, insulin pumps, metallic splinters in the eye, ferromagnetic haemostatic clips in central nervous systems or vascular vessels.

5. Significant systemic or major illness other than liver disease, including auto-immune disease, coronary artery disease, cerebrovascular disease, malignant neoplasms, pulmonary disease, renal insufficiency, serious psychiatric disease, and/or other serious disease, that, in the opinion of the Investigator would preclude the subject from participating in and completing the study

6. Documented history of serious allergic reaction to SNP-610 or any structurally related compounds

7. Diabetic patients who have not maintained a stable dose of oral medication for hyperglycemia or have had more than 10 percent change in their insulin dose over the past two months

8. Regular use of agents that are potent against hepatitis or affecting lipid metabolisms, including but not limited to HMGCoA reductase inhibitors (statins), fibrates, silymarin, N-acetylcysteine, or anti-TNF therapies.

Note: refer to Section 6.5 Prohibited agents for details.

9. Pregnant or lactating

10. Female of child-bearing potential who are not committed to take reliable contraception during the participation of the study and at least 4 weeks after the end of the study treatment