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

NCT03868566 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-01-06

No results posted yet for this study

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

Interventions

DRUG

SNP-612 dose1

Subjects will take dose1 once a day orally for 12 weeks

DRUG

SNP-612 dose2

Subjects will take dose2 once a day orally for 12 weeks

Sponsors & Collaborators

  • Sinew Pharma Inc.

    lead INDUSTRY

Principal Investigators

  • Yu-Lueng Shih, MD,PhD · Tri-Service General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-04
Primary Completion
2021-09-22
Completion
2021-10-19

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03868566 on ClinicalTrials.gov