NCT04052516

A Phase 2b Study of Icosabutate in Fatty Liver Disease

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: NorthSea Therapeutics B.V. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Non Alcoholic Steatohepatitis (NASH)

Interventions

Type	Name	Description
DRUG	Icosabutate	Icosabutate oral capsule once daily
DRUG	Placebo	Matching placebo oral capsule

Timeline

• Start date: 2019-07-17
• Primary completion: 2022-02-20
• Completion: 2022-12-19
• First posted: 2019-08-09
• Last updated: 2025-02-28
• Results posted: 2025-02-28

Locations

39 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study