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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 May 2023
• Main ID: NCT03468556
• Date of registration: 06/03/2018
• Prospective Registration: Yes
• Primary sponsor: Sinew Pharma Inc.
• Public title: 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
• Scientific title: 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
• Date of first enrolment: March 1, 2024
• Target sample size: 80
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT03468556
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Taiwan

Contacts

• Name: Jia-Yu Hao, MS

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

NASH - Nonalcoholic Steatohepatitis

Intervention(s)

Drug: SNP-610

Drug: Placebo Oral Tablet

Primary Outcome(s)

Alanine aminotransferase [Time Frame: 12 weeks]

Secondary Outcome(s)

Total bilirubin [Time Frame: 12 weeks]

Alkaline phosphatase [Time Frame: 12 weeks]

MRI liver FF [Time Frame: 12 weeks]

Aspartate aminotransferase [Time Frame: 12 weeks]

Galactose single point [Time Frame: 12 weeks]

CK-18 [Time Frame: 12 weeks]

Gamma-glutamyl transpeptidase [Time Frame: 12 weeks]

Secondary ID(s)

SNP-610-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors