drugset / Trial / NCT03468556

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 ↗

Phase 2 Not yet recruiting 80 enrolled Sinew Pharma Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2026-04-01
Primary completion
2027-04-30
Completion
2027-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject SNP-610 Unknown 800 mg Oral