TABLE 1.

Selected studies of drugs for NASH cirrhosis in Phase II/III development

Agent	Mechanism	Phase	ClinicalTrials.gov number	Progress/results	Date of completion or expected completion
Simtuzumab 42	Monoclonal antibody against lysyl oxidase‐like 2	IIb	NCT01672879	Ineffective in decreasing hepatic venous pressure gradient	Jan 2017
Selonsertib 41	Selective inhibitor of ASK1	III	NCT03053063	Ineffective in improving fibrosis without worsening NASH	May 2019
Emricasan 44	Pan‐caspase inhibitor	II	NCT03205345	No reduction in composite outcome of mortality, decompensation or rise in MELD‐NA score ≥4 points	Aug 2019
Pegbelfermin 45	PEGylated fibroblast growth factor 21 (FGF21) analogue	IIa	NCT03486912	Ineffective in improving fibrosis without worsening NASH	Oct 2021
Aldafermin	Fibroblast growth factor 19 analogue	II	NCT04210245	Ongoing; primary outcome: ≥ 1‐stage improvement in fibrosis without worsening NASH	Sep 2022
Belapectin	Inhibitor of galectin 3	IIb/3	NCT04365868	Ongoing; primary outcome: proportion of patients who develop new oesophageal varices	Dec 2023
Semaglutide ± Cilofexor/Firsocostat	Glucagon‐like peptide‐1 receptor agonist (semaglutide)	II	NCT04971785	Ongoing; primary outcome: ≥1‐stage improvement in fibrosis without worsening NASH	Mar 2024
Efruxifermin	Fc‐ fibroblast growth factor 21 fusion protein	IIb	NCT05039450	Ongoing; primary outcome: change from baseline in fibrosis regression with no worsening steatohepatitis	Apr 2024
BMS‐986263	siRNA designed to degrade HSP47 mRNA	II	NCT04267393	Ongoing; primary outcome: ≥ 1‐stage improvement in fibrosis without worsening NASH	Jul 2024

Abbreviations: MELD, model for end‐stage liver disease; NASH, non‐alcoholic steatohepatitis.