Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
280 participants
INTERVENTIONAL
2019-07-17
2022-12-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo oral capsules taken one daily for 52 weeks
Placebo
Matching placebo oral capsule
Icosabutate 300mg
Icosabutate 300mg oral capsule taken once daily for 52 weeks
Icosabutate
Icosabutate oral capsule once daily
Icosabutate 600mg
Icosabutate 600mg oral capsules taken once daily for 52 weeks
Icosabutate
Icosabutate oral capsule once daily
Interventions
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Icosabutate
Icosabutate oral capsule once daily
Placebo
Matching placebo oral capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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NorthSea Therapeutics B.V.
INDUSTRY
Responsible Party
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Locations
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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
Alliance Clinical Research
Poway, California, United States
National Research Institute - Santa Ana
Santa Ana, California, United States
South Denver Gastroenterology
Englewood, Colorado, United States
Excel Medical Clinical Trials, LLC
Boca Raton, Florida, United States
Sensible Healthcare LLC
Ocoee, Florida, United States
Covenant Research LLC
Sarasota, Florida, United States
Gastrointestinal Specialists of Georgia PC
Marietta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Texas Digestive Disease Consultants
Baton Rouge, Louisiana, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Gastrointestinal Associates, PA
Flowood, Mississippi, United States
Southern Therapy and Advanced Research LLC
Jackson, Mississippi, United States
Kansas City Research Institute
Kansas City, Missouri, United States
Cumberland Research Associates, LLC
Fayetteville, North Carolina, United States
Aventiv Research, Inc.
Columbus, Ohio, United States
Premier Research
Clarksville, Tennessee, United States
Gastro One
Germantown, Tennessee, United States
Pinnacle Clinical Research
Austin, Texas, United States
Texas Digestive Disease Consultants
Dallas, Texas, United States
South Texas Research Institute
Edinburg, Texas, United States
Liver Associates of Texas
Houston, Texas, United States
Doctors Hospital at Renaissance, LLC
McAllen, Texas, United States
Quality Research Inc
San Antonio, Texas, United States
American Research Corporation
San Antonio, Texas, United States
Pinnacle Clinical Research
San Antonio, Texas, United States
Brooke Army Medical Center
San Antonio, Texas, United States
Texas Digestive Disease Consultants - Webster
Webster, Texas, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States
Fundacion de Investigacion (FDI)
San Juan, , Puerto Rico
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NST-02
Identifier Type: -
Identifier Source: org_study_id
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