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

Primary Purpose

Non Alcoholic Steatohepatitis (NASH)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Icosabutate
Placebo
Sponsored by
NorthSea Therapeutics B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Alcoholic Steatohepatitis (NASH)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Central ResearchAssociates Inc.
  • Arizona Liver Health
  • Arizona Liver Health - Glendale
  • Arizona Liver Health
  • Adobe Clinical Research, LLC
  • Arkansas Gastroenterology - North Little Rock
  • Fresno Clinical Research Center
  • National Research Institute - Huntington Park
  • National Research Institute - Wilshire
  • National Research Institute - Panorama
  • Alliance Clinical Research
  • National Research Institute - Santa Ana
  • South Denver Gastroenterology
  • Excel Medical Clinical Trials, LLC
  • Sensible Healthcare LLC
  • Covenant Research LLC
  • Gastrointestinal Specialists of Georgia PC
  • University of Chicago
  • Texas Digestive Disease Consultants
  • Tandem Clinical Research
  • Gastrointestinal Associates, PA
  • Southern Therapy and Advanced Research LLC
  • Kansas City Research Institute
  • Cumberland Research Associates, LLC
  • Aventiv Research, Inc.
  • Premier Research
  • Gastro One
  • Pinnacle Clinical Research
  • Texas Digestive Disease Consultants
  • South Texas Research Institute
  • Liver Associates of Texas
  • Doctors Hospital at Renaissance, LLC
  • Quality Research Inc
  • American Research Corporation
  • Pinnacle Clinical Research
  • Brooke Army Medical Center
  • Texas Digestive Disease Consultants - Webster
  • Hunter Holmes McGuire VA Medical Center
  • Fundacion de Investigacion (FDI)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Icosabutate 300mg

Icosabutate 600mg

Arm Description

Placebo oral capsules taken one daily for 52 weeks

Icosabutate 300mg oral capsule taken once daily for 52 weeks

Icosabutate 600mg oral capsules taken once daily for 52 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
Changes in the liver enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L from baseline
Change in bilirubin mg/dL from baseline

Full Information

First Posted
August 7, 2019
Last Updated
March 6, 2023
Sponsor
NorthSea Therapeutics B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT04052516
Brief Title
A Phase 2b Study of Icosabutate in Fatty Liver Disease
Acronym
ICONA
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of NST-4016 in Patients With Nonalcoholic Steatohepatitis (NASH)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 17, 2019 (Actual)
Primary Completion Date
February 20, 2022 (Actual)
Study Completion Date
December 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NorthSea Therapeutics B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Alcoholic Steatohepatitis (NASH)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo oral capsules taken one daily for 52 weeks
Arm Title
Icosabutate 300mg
Arm Type
Experimental
Arm Description
Icosabutate 300mg oral capsule taken once daily for 52 weeks
Arm Title
Icosabutate 600mg
Arm Type
Experimental
Arm Description
Icosabutate 600mg oral capsules taken once daily for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Icosabutate
Other Intervention Name(s)
NST-4016
Intervention Description
Icosabutate oral capsule once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo oral capsule
Primary Outcome Measure Information:
Title
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.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in Nonalcoholic fatty liver disease (NAFLD) activity score (NAS)
Description
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
Time Frame
52 weeks
Title
Changes in individual histological scores for steatosis, ballooning, inflammation, and fibrosis from baseline
Description
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
Time Frame
52 weeks
Title
Changes in the liver enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L from baseline
Time Frame
52 weeks
Title
Change in bilirubin mg/dL from baseline
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Central ResearchAssociates Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Arizona Liver Health
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Arizona Liver Health - Glendale
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Arizona Liver Health
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Adobe Clinical Research, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Arkansas Gastroenterology - North Little Rock
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Fresno Clinical Research Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
National Research Institute - Huntington Park
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
National Research Institute - Wilshire
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
National Research Institute - Panorama
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Alliance Clinical Research
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
National Research Institute - Santa Ana
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Facility Name
South Denver Gastroenterology
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Excel Medical Clinical Trials, LLC
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Facility Name
Sensible Healthcare LLC
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Covenant Research LLC
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34240
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Texas Digestive Disease Consultants
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Gastrointestinal Associates, PA
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Southern Therapy and Advanced Research LLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Kansas City Research Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Cumberland Research Associates, LLC
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Aventiv Research, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Premier Research
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37040
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Pinnacle Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
Texas Digestive Disease Consultants
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
South Texas Research Institute
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
Liver Associates of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Doctors Hospital at Renaissance, LLC
City
McAllen
State/Province
Texas
ZIP/Postal Code
78504
Country
United States
Facility Name
Quality Research Inc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
American Research Corporation
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Pinnacle Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Brooke Army Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Texas Digestive Disease Consultants - Webster
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Fundacion de Investigacion (FDI)
City
San Juan
ZIP/Postal Code
00927-4807
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase 2b Study of Icosabutate in Fatty Liver Disease

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