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

Phase 2 Terminated 90 enrolled Sinew Pharma Inc.

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Outcome

Met primary endpoint

Stopped (Enrollment): “recruitment difficulties due to Covid-19”

paper In the clinical trial, patients treated with SNP-630-MS exhibited significant improvement in ALT levels at week 12 compared with baseline levels PMID 39402603 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SNP-612	Unknown	—	Oral