A Phase 2b Study of Icosabutate in Fatty Liver Disease

Non Alcoholic Steatohepatitis (NASH) Clinical Trial

— ICONA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04052516
• Other study ID #: NST-02
• Status: Completed
• Phase: Phase 2
• Start date: July 17, 2019
• Est. completion date: December 19, 2022

Study information

• Verified date: March 2023
• Source: NorthSea Therapeutics B.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: December 19, 2022
• Est. primary completion date: February 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Icosabutate
Icosabutate oral capsule once daily
• Placebo
Matching placebo oral capsule

Locations

Country	Name	City	State
Puerto Rico	Fundacion de Investigacion (FDI)	San Juan
United States	Pinnacle Clinical Research	Austin	Texas
United States	Texas Digestive Disease Consultants	Baton Rouge	Louisiana
United States	Central ResearchAssociates Inc.	Birmingham	Alabama
United States	Excel Medical Clinical Trials, LLC	Boca Raton	Florida
United States	Arizona Liver Health	Chandler	Arizona
United States	University of Chicago	Chicago	Illinois
United States	Premier Research	Clarksville	Tennessee
United States	Aventiv Research, Inc.	Columbus	Ohio
United States	Texas Digestive Disease Consultants	Dallas	Texas
United States	South Texas Research Institute	Edinburg	Texas
United States	South Denver Gastroenterology	Englewood	Colorado
United States	Cumberland Research Associates, LLC	Fayetteville	North Carolina
United States	Gastrointestinal Associates, PA	Flowood	Mississippi
United States	Fresno Clinical Research Center	Fresno	California
United States	Gastro One	Germantown	Tennessee
United States	Arizona Liver Health - Glendale	Glendale	Arizona
United States	Liver Associates of Texas	Houston	Texas
United States	National Research Institute - Huntington Park	Huntington Park	California
United States	Southern Therapy and Advanced Research LLC	Jackson	Mississippi
United States	Kansas City Research Institute	Kansas City	Missouri
United States	National Research Institute - Wilshire	Los Angeles	California
United States	Gastrointestinal Specialists of Georgia PC	Marietta	Georgia
United States	Tandem Clinical Research	Marrero	Louisiana
United States	Doctors Hospital at Renaissance, LLC	McAllen	Texas
United States	Arkansas Gastroenterology - North Little Rock	North Little Rock	Arkansas
United States	Sensible Healthcare LLC	Ocoee	Florida
United States	National Research Institute - Panorama	Panorama City	California
United States	Alliance Clinical Research	Poway	California
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia
United States	American Research Corporation	San Antonio	Texas
United States	Brooke Army Medical Center	San Antonio	Texas
United States	Pinnacle Clinical Research	San Antonio	Texas
United States	Quality Research Inc	San Antonio	Texas
United States	National Research Institute - Santa Ana	Santa Ana	California
United States	Covenant Research LLC	Sarasota	Florida
United States	Adobe Clinical Research, LLC	Tucson	Arizona
United States	Arizona Liver Health	Tucson	Arizona
United States	Texas Digestive Disease Consultants - Webster	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
NorthSea Therapeutics B.V.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients with resolution of NASH, defined as disappearance of ballooning (score = 0) with lobular inflammation score 0 or 1, with no worsening of fibrosis.		52 weeks
Secondary	Change from baseline in Nonalcoholic fatty liver disease (NAFLD) activity score (NAS)	A histological scoring system that assesses a liver biopsy and gives scores for steatosis (0-3), lobular inflammation (0-3), and hepatocyte ballooning (0-2) giving a total score of (0-8). The higher the score the more severe the disease	52 weeks
Secondary	Changes in individual histological scores for steatosis, ballooning, inflammation, and fibrosis from baseline	Changes in scores for the individual component parts of the Nonalcoholic fatty liver disease (NAFLD) activity score (NAS) as judged by a pathologist examining sections from a liver biopsy; steatosis (range 0-3), lobular inflammation (range 0-3), and hepatocyte ballooning (range 0-2) In all cases a higher number denotes more severe disease activity	52 weeks
Secondary	Changes in the liver enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L from baseline		52 weeks
Secondary	Change in bilirubin mg/dL from baseline		52 weeks