An Open-Label Study to Assess the Hepatic Protection Effect of SNP-612, in Patients With NAFLD

NCT03868566 | Terminated Phase 2

• 1 other identifier: SNP-612-202
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to compare the changes in ALT to baseline among patients with non-alcoholic fatty liver disease (NAFLD) following the 3-month treatment of 3 different dosing regimens of SNP-612. The secondary objectives will be to compare the changes in other liver function tests, cytokeratin-18 (CK-18) fragment level and adverse event / serious adverse event rates.

Conditions

NASH - Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• Change in serum ALT

  A reduction from baseline (i.e. a negative percent value) indicates an improvement in condition

  12 weeks

Secondary Outcomes (8)

• Change in serum AST

  12 weeks

• Change in serum Alk-P

  12 weeks

• Change in serum γ-GT

  12 weeks

• Change in GSP

  12 weeks

• Change in liver fat content as measured by liver fat fraction (FF) with magnetic resonance imaging method.

  12 weeks

Other Outcomes (6)

• Insulin resistance

  12 weeks

• Triglycerides

  12 weeks

• Low density lipoprotein

  12 weeks

Study Arms (2)

SNP-612 dose1

EXPERIMENTAL

dose1 once a day orally for 12 weeks

Drug: SNP-612 dose1

SNP-612 dose2

EXPERIMENTAL

dose2 once a day orally for 12 weeks

Drug: SNP-612 dose2

Interventions

SNP-612 dose1 DRUG

Subjects will take dose1 once a day orally for 12 weeks

SNP-612 dose1

SNP-612 dose2 DRUG

Subjects will take dose2 once a day orally for 12 weeks

SNP-612 dose2

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 agentagent administration.
• Phenotypic diagnosis of NASH based on one or more of the following:
• Alanine aminotransferase (ALT) levels ≥ 1.5x upper limit of normal (ULN) on at least two occasions, seven or more days apart, prior to study agent administration
• ALT ≥ ULN on at least two occasions, seven or more days apart, prior to study agent administration AND body mass index (BMI) ≥ 25 AND diagnosis of Type 2 DM
• 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:

• Subjects who meet any of the following criteria are not eligible to enter the study:
• 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 \> ULN, or ALT or AST \> 5 x ULN, or Alkaline phosphatase (ALP) \> 2x 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-612 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

Sponsors & Collaborators

• Sinew Pharma Inc.: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Related Publications (1)

• Ho HT, Shih YL, Huang TY, Fang WH, Liu CH, Lin JC, Hsiang CW, Chu KM, Hsiong CH, Chen GJ, Wu YE, Hao JY, Liang CW, Hu OY. Mixed active metabolites of the SNP-6 series of novel compounds mitigate metabolic dysfunction-associated steatohepatitis and fibrosis: promising results from pre-clinical and clinical trials. J Transl Med. 2024 Oct 14;22(1):936. doi: 10.1186/s12967-024-05686-7.

  PMID: 39402603 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Yu-Lueng Shih, MD,PhD

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Experimental: SNP-612 dose1 Experimental: SNP-612 dose2

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 11, 2019
• Study Start: August 4, 2017
• Primary Completion: September 22, 2021
• Study Completion: October 19, 2021
• Last Updated: January 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)