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

NCT03468556 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: SNP-610-201
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

NASH - Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• Alanine aminotransferase

  Absolute change from baseline in serum alanine aminotransferase (ALT/GPT)

  12 weeks

Secondary Outcomes (8)

• MRI liver FF

  12 weeks

• MRI liver FF

  12 weeks

• Aspartate aminotransferase

  12 weeks

• Alkaline phosphatase

  12 weeks

• Gamma-glutamyl transpeptidase

  12 weeks

Other Outcomes (8)

• Insulin resistance

  12 weeks

• Triglycerides

  12 weeks

• Low density lipoprotein

  12 weeks

Study Arms (2)

test drug

EXPERIMENTAL

2 tabs of SNP-610

Drug: SNP-610

placebo

PLACEBO COMPARATOR

2 tabs of placebo

Drug: Placebo Oral Tablet

Interventions

SNP-610 DRUG

Subjects will take 2 tablets once a day orally for 12 weeks

test drug

Placebo Oral Tablet DRUG

Subjects will take 2 tablets once a day orally for 12 weeks

placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 20 years
• Body weight ≥ 54 kg
• 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.
• 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
• Have adequate organ functions as defined by the following examinations prior to the start of study treatment:
• 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
• Renal: creatinine clearance ≥ 90 mL/min (by Cockcroft-Gault equation), serum uric acid \< 9.0 mg/dL
• Able to provide written informed consent, and understand and comply with the requirements of the study

You may not qualify if:

• Decompensated or severe liver disease as evidenced by one or more of the following:
• Confirmed cirrhosis or suspicion of cirrhosis
• Liver transplant
• Liver malignancy
• Ascites
• Bilirubin \>2 x ULN, or ALT or AST \> 10 x ULN
• Acute or chronic hepatitis A, B, C, HIV, or other liver diseases affecting liver function.
• Patients with cysts, hemangiomas, or similar abnormalities, are accepted.
• 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
• Subjects who are unable to undergo an MRI scan.
• 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.
• 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
• Documented history of serious allergic reaction to SNP-610 or any structurally related compounds
• 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
• 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.

Sponsors & Collaborators

• Sinew Pharma Inc.: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Jia-Yu Hao, MS

CONTACT

+886-2788-5365; ariel.hao@sinewpharma.com

Chiao-Yi Tien, MS

CONTACT

+886-8792-3100; tcy@sinewpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: test drug

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 16, 2018
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 18, 2026

Record last verified: 2025-05