NCT03868566 is a Phase 2 clinical trial of SNP-612 dose1 in NASH - Nonalcoholic Steatohepatitis, sponsored by Sinew Pharma Inc..

Who is sponsoring NCT03868566?

NCT03868566 is sponsored by Sinew Pharma Inc..

What drugs are being tested in NCT03868566?

Interventions in NCT03868566: SNP-612 dose1, SNP-612 dose2.

What condition does NCT03868566 study?

NCT03868566 studies NASH - Nonalcoholic Steatohepatitis.

Is NCT03868566 still recruiting?

NCT03868566 is currently terminated. Last updated 6 January 2023.

Last reviewed 2023-01-06 · How we verify

NCT03868566

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 2 Last updated 6 January 2023

What this trial tests

Phase 2 trial testing SNP-612 dose1 in NASH - Nonalcoholic Steatohepatitis in 90 participants. Terminated before completion.

Timeline

4 August 2017

Primary endpoint
22 September 2021

19 October 2021

Quick facts

Lead sponsor	Sinew Pharma Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	90
Start date	4 August 2017
Primary completion	22 September 2021
Estimated completion	19 October 2021
Sites	1 location across Taiwan

Drugs / interventions tested

SNP-612 dose1 — full drug profile →
SNP-612 dose2

Conditions studied

NASH - Nonalcoholic Steatohepatitis — all drugs for NASH - Nonalcoholic Steatohepatitis →

Sponsor

Sinew Pharma Inc. — full company profile →

Who can join

20 and older, any sex, with NASH - Nonalcoholic Steatohepatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Nuclear receptors in health and disease: signaling pathways, biological functions and pharmaceutical interventions.
Jin P, Duan X, Huang Z, Dong Y, et al · · 2025 · cited 21× · PMID 40717128 · DOI 10.1038/s41392-025-02270-3
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.
Ho HT, Shih YL, Huang TY, Fang WH, et al · · 2024 · cited 4× · PMID 39402603 · DOI 10.1186/s12967-024-05686-7

Verify or expand the search:

Other recruiting trials for NASH - Nonalcoholic Steatohepatitis

Currently open trials in the same condition.

NCT05499949 — The Franciscus Obesity NASH Study · active not recruiting
NCT05023044 — Nonalcoholic Fatty Liver Disease in HIV Database · active not recruiting
NCT04232566 — Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity · recruiting
NCT05165446 — Novel MRE Technique to Assess a Risk Factor for Liver Cancer · active not recruiting
NCT04697810 — Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH) · Phase 2 · recruiting

Other Sinew Pharma Inc. trials

Trials by the same sponsor.

NCT03468556 — A Randomized, Double-Blind, Placebo Controlled Study to Assess the Efficacy and Safety of SNP-610 for the Treatment of P · Phase 2 · not yet recruiting
NCT05842733 — A Novel, Potent and Non-addictive Analgesic of Combinations for Knee Replacement Moderate to Severe Pain Management · Phase 2 · unknown
NCT03451487 — A Randomized, Single-blind, Parallel Group and Multiple - Dose Design Study · NA · completed
NCT04808154 — A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of SNP-630 in Health Subjects. · Phase 1 · completed
NCT05983328 — Phase I Pharmacokinetic Study of HUYPS-1 in Healthy Volunteers · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03868566 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sinew Pharma Inc.
Last refreshed: 6 January 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03868566.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing