A Phase 2b Study of Icosabutate in Fatty Liver Disease

Summary

A Phase 2b study to evaluate the efficacy of different doses of NST-4016 on the resolution of NASH without worsening of fibrosis

Timeline

Start

2019-07-17

Primary completion

2022-02-20

Completion

2022-12-19

Outcome

Missed primary endpoint

paper Although the primary endpoint was not met PMID 39938653 ↗

registry p = 0.1386; Odds Ratio (OR) 2.01 (95% CI 0.80 to 5.08) NCT04052516 ↗

Publications

• Harrison SA, Alkhouri N, Ortiz-Lasanta G, Rudraraju M, Tai D, Wack K, Shah A, Besuyen R, Steineger HH, Fraser DA, Sanyal AJ; ICONA Study Investigators. A phase IIb randomised-controlled trial of the FFAR1/FFAR4 agonist icosabutate in MASH. J Hepatol. 2025 Aug;83(2):293-303. doi: 10.1016/j.jhep.2025.01.032. Epub 2025 Feb 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Icosabutate	Small molecule	300 mg	Oral
Subject	Icosabutate	Small molecule	600 mg	Oral

Indications