NCT02686762: ENCORE-NF

Emricasan, a Caspase Inhibitor, for Evaluation in Subjects With Non-Alcoholic Steatohepatitis (NASH) Fibrosis

Completed Phase 2 Last updated 19 August 2019

What this trial tests

Phase 2 trial testing Emricasan (5 mg) in Non-alcoholic Steatohepatitis in 318 participants. Completed in 28 February 2019.

Timeline

26 January 2016

Primary endpoint
29 January 2019

28 February 2019

Quick facts

Lead sponsor	Conatus Pharmaceuticals Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	318
Start date	26 January 2016
Primary completion	29 January 2019
Estimated completion	28 February 2019
Sites	103 locations across United States, Germany, Spain

Drugs / interventions tested

• Emricasan (5 mg) — full drug profile →
• Emricasan (50 mg) — full drug profile →
• Placebo

Conditions studied

• Non-alcoholic Steatohepatitis — all drugs for Non-alcoholic Steatohepatitis →
• Fibrosis — all drugs for Fibrosis →
• Liver Diseases — all drugs for Liver Diseases →

Sponsor

Conatus Pharmaceuticals Inc. — full company profile →

Who can join

18 and older, any sex, with Non-alcoholic Steatohepatitis or Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, double-blind, randomized, placebo-controlled trial involving subjects with a diagnosis of "definite NASH" with fibrosis (excluding cirrhosis) as determined by the central histopathologist. Upon successful screening, subjects will be randomized to receive either emricasan 50 mg BID or emricasan 5 mg BID or matching placebo BID.

Publications & conference data

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

1. Mechanisms of NAFLD development and therapeutic strategies.
   Friedman SL, Neuschwander-Tetri BA, Rinella M, Sanyal AJ. · · 2018 · cited 3203× · PMID 29967350 · DOI 10.1038/s41591-018-0104-9
2. Hepatic stellate cells as key target in liver fibrosis.
   Higashi T, Friedman SL, Hoshida Y. · · 2017 · cited 1148× · PMID 28506744 · DOI 10.1016/j.addr.2017.05.007
3. Current and future pharmacological therapies for NAFLD/NASH.
   Sumida Y, Yoneda M. · · 2018 · cited 487× · PMID 29247356 · DOI 10.1007/s00535-017-1415-1
4. Apoptosis and necroptosis in the liver: a matter of life and death.
   Schwabe RF, Luedde T. · · 2018 · cited 447× · PMID 30250076 · DOI 10.1038/s41575-018-0065-y
5. Targeted therapeutics and novel signaling pathways in non-alcohol-associated fatty liver/steatohepatitis (NAFL/NASH).
   Xu X, Poulsen KL, Wu L, Liu S, et al · · 2022 · cited 235× · PMID 35963848 · DOI 10.1038/s41392-022-01119-3
6. Mitochondria-associated programmed cell death as a therapeutic target for age-related disease.
   Nguyen TT, Wei S, Nguyen TH, Jo Y, et al · · 2023 · cited 221× · PMID 37612409 · DOI 10.1038/s12276-023-01046-5
7. Non-alcoholic steatohepatitis pathogenesis: sublethal hepatocyte injury as a driver of liver inflammation.
   Ibrahim SH, Hirsova P, Gores GJ. · · 2018 · cited 216× · PMID 29367207 · DOI 10.1136/gutjnl-2017-315691
8. Macrophages in obesity and non-alcoholic fatty liver disease: Crosstalk with metabolism.
   Lefere S, Tacke F. · · 2019 · cited 209× · PMID 32149275 · DOI 10.1016/j.jhepr.2019.02.004