A Phase 2b Study of Icosabutate in Fatty Liver Disease
ICONA
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of NST-4016 in Patients With Nonalcoholic Steatohepatitis (NASH)
1 other identifier
interventional
280
2 countries
39
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2019
Typical duration for phase_2
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 17, 2019
CompletedFirst Submitted
Initial submission to the registry
August 7, 2019
CompletedFirst Posted
Study publicly available on registry
August 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2022
CompletedResults Posted
Study results publicly available
February 28, 2025
CompletedFebruary 28, 2025
February 1, 2025
2.6 years
August 7, 2019
January 9, 2025
February 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (12)
Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement and no Worsening of Steatohepatitis (Inflammation/Ballooning).
52 weeks
Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement.
52 weeks
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
Change in Bilirubin Micromol/L From Baseline
52 weeks
Change From Baseline in Inflammation Marker hsCRP
52 weeks
- +7 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo oral capsules taken one daily for 52 weeks
Icosabutate 300mg
EXPERIMENTALIcosabutate 300mg oral capsule taken once daily for 52 weeks
Icosabutate 600mg
EXPERIMENTALIcosabutate 600mg oral capsules taken once daily for 52 weeks
Interventions
Icosabutate oral capsule once daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Central ResearchAssociates Inc.
Birmingham, Alabama, 35205, United States
Arizona Liver Health
Chandler, Arizona, 85224, United States
Arizona Liver Health - Glendale
Glendale, Arizona, 85306, United States
Arizona Liver Health
Tucson, Arizona, 85711, United States
Adobe Clinical Research, LLC
Tucson, Arizona, 85712, United States
Arkansas Gastroenterology - North Little Rock
North Little Rock, Arkansas, 72117, United States
Fresno Clinical Research Center
Fresno, California, 93720, United States
National Research Institute - Huntington Park
Huntington Park, California, 90255, United States
National Research Institute - Wilshire
Los Angeles, California, 90057, United States
National Research Institute - Panorama
Panorama City, California, 91402, United States
Alliance Clinical Research
Poway, California, 92064, United States
National Research Institute - Santa Ana
Santa Ana, California, 92704, United States
South Denver Gastroenterology
Englewood, Colorado, 80113, United States
Excel Medical Clinical Trials, LLC
Boca Raton, Florida, 33434, United States
Sensible Healthcare LLC
Ocoee, Florida, 34761, United States
Covenant Research LLC
Sarasota, Florida, 34240, United States
Gastrointestinal Specialists of Georgia PC
Marietta, Georgia, 30060, United States
University of Chicago
Chicago, Illinois, 60637, United States
Texas Digestive Disease Consultants
Baton Rouge, Louisiana, 70809, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
Gastrointestinal Associates, PA
Flowood, Mississippi, 39232, United States
Southern Therapy and Advanced Research LLC
Jackson, Mississippi, 39216, United States
Kansas City Research Institute
Kansas City, Missouri, 64131, United States
Cumberland Research Associates, LLC
Fayetteville, North Carolina, 28304, United States
Aventiv Research, Inc.
Columbus, Ohio, 43213, United States
Premier Research
Clarksville, Tennessee, 37040, United States
Gastro One
Germantown, Tennessee, 38138, United States
Pinnacle Clinical Research
Austin, Texas, 78746, United States
Texas Digestive Disease Consultants
Dallas, Texas, 75246, United States
South Texas Research Institute
Edinburg, Texas, 78539, United States
Liver Associates of Texas
Houston, Texas, 77030, United States
Doctors Hospital at Renaissance, LLC
McAllen, Texas, 78504, United States
Quality Research Inc
San Antonio, Texas, 78209, United States
American Research Corporation
San Antonio, Texas, 78215, United States
Pinnacle Clinical Research
San Antonio, Texas, 78229, United States
Brooke Army Medical Center
San Antonio, Texas, 78234, United States
Texas Digestive Disease Consultants - Webster
Webster, Texas, 77598, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249, United States
Fundacion de Investigacion (FDI)
San Juan, 00927-4807, Puerto Rico
Related Publications (1)
Harrison SA, Alkhouri N, Ortiz-Lasanta G, Rudraraju M, Tai D, Wack K, Shah A, Besuyen R, Steineger HH, Fraser DA, Sanyal AJ; ICONA Study Investigators. A phase IIb randomised-controlled trial of the FFAR1/FFAR4 agonist icosabutate in MASH. J Hepatol. 2025 Aug;83(2):293-303. doi: 10.1016/j.jhep.2025.01.032. Epub 2025 Feb 10.
PMID: 39938653DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Scientific Officer
- Organization
- NorthSea Therapeutics BV
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2019
First Posted
August 9, 2019
Study Start
July 17, 2019
Primary Completion
February 20, 2022
Study Completion
December 19, 2022
Last Updated
February 28, 2025
Results First Posted
February 28, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share