MedTrace Logo

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 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-18

No results posted yet for this study

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

Interventions

DRUG

SNP-610

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

DRUG

Placebo Oral Tablet

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

Sponsors & Collaborators

  • Sinew Pharma Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

More Related Trials

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 NCT03468556 on ClinicalTrials.gov