A Phase 2b Study of Icosabutate in Fatty Liver Disease — ICONA

Non Alcoholic Steatohepatitis (NASH) Clinical Trial

Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of NST-4016 in Patients With Nonalcoholic Steatohepatitis (NASH)

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

This is a 62 week (including screening and follow-up), multicenter, randomized, double blind, placebo-controlled, parallel group study in male and female patients with a histological diagnosis of NASH. The study includes a screening period, double blind treatment period, and post-treatment follow up ;

Study Design

Related Conditions & MeSH terms

Fatty Liver
Non Alcoholic Steatohepatitis (NASH)
Non-alcoholic Fatty Liver Disease

Clinical Trial Details

NCT number	NCT04052516
Study type	Interventional
Source	NorthSea Therapeutics B.V.
Contact
Status	Completed
Phase	Phase 2
Start date	July 17, 2019
Completion date	December 19, 2022

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT02548351` - Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment	Phase 3
Recruiting	`NCT04880187` - Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis	Phase 2
Completed	`NCT02098317` - DHA and Vitamin D in Children With Biopsy-proven NAFLD	Phase 3
Terminated	`NCT04065841` - Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.	Phase 2