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A Phase 2b Study of Icosabutate in Fatty Liver Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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)

NCT04052516•NorthSea Therapeutics B.V.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Provides signed written informed consent and agrees to comply with the study protocol.
•Is a male or female aged 18 to 75 years, inclusive.
•Has a histological diagnosis of NASH prior to study entry
•Has (NAS) greater than or equal to 4, with a score of at least 1 in each component (steatosis, lobular inflammation, and ballooning),
•Has a fibrosis score F1 to F3, inclusive (F1 capped at 30%),
•Has a Proton Density Fat Fraction (PDFF) greater than or equal to 10% on MRI at screening

Exclusion Criteria

•Has a known history of alcohol abuse or daily heavy alcohol consumption
•Has had bariatric surgery within the past 5 years
•Has significant systemic or major illnesses other than liver disease
•Has a recent (within 6 months) history of cardiac dysrhythmias and/or cardiovascular disease
•Has uncontrolled arterial hypertension
•Positive for Hep B, Hepatitis C Virus (HCV) or HCV Polymerase Chain Reaction (PCR)
•Has type 1 diabetes mellitus
•Has diabetic ketoacidosis
•Has a history of liver decompensation

Locations (39)

Central ResearchAssociates Inc.

Birmingham, Alabama, United States

Arizona Liver Health

Chandler, Arizona, United States

Arizona Liver Health - Glendale

Glendale, Arizona, United States

Arizona Liver Health

Tucson, Arizona, United States

Adobe Clinical Research, LLC

Tucson, Arizona, United States

Arkansas Gastroenterology - North Little Rock

North Little Rock, Arkansas, United States

Fresno Clinical Research Center

Fresno, California, United States

National Research Institute - Huntington Park

Huntington Park, California, United States

National Research Institute - Wilshire

Los Angeles, California, United States

National Research Institute - Panorama

Panorama City, California, United States

Key Dates

Start Date

July 17, 2019

Primary Completion Date

February 20, 2022

Completion Date

December 19, 2022

Last Updated

February 28, 2025

Enrollment

280

ACTUAL participants

Conditions

Non Alcoholic Steatohepatitis (NASH)

Interventions

Icosabutate

DRUG

Placebo

DRUG

Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment

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Non Alcoholic Steatohepatitis (NASH)

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UNKNOWNPHASE2

Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis

NCT04880187

Non Alcoholic Steatohepatitis (NASH)

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DHA and Vitamin D in Children With Biopsy-proven NAFLD

NCT02098317

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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