Clinical Trial Details

Trial ID: L0222
Source ID: NCT04052516
Associated Drug: Icosabutate
Title: A Phase 2b Study of Icosabutate in Fatty Liver Disease
Acronym: ICONA
Status: Active, not recruiting
Study Results: No Results Available
Results: --
Conditions: Non Alcoholic Steatohepatitis (NASH)
Interventions: Drug: Icosabutate|Drug: Placebo
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.|Change from baseline in Nonalcoholic fatty liver disease (NAFLD) activity score (NAS)|Changes in individual histological scores for steatosis, ballooning, inflammation, and fibrosis from baseline|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
Sponsor/Collaborators: NorthSea Therapeutics B.V.
Gender: All
Age: 18 Years to 75 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 280
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: July 17, 2019
Completion Date: January 30, 2023
Results First Posted: --
Last Update Posted: December 20, 2021
Locations: 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
URL: https://ClinicalTrials.gov/show/NCT04052516

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D179 Icosabutate Chemical drug DB12990 -- -- Under clinical trials Details
D199 L-alanine Chemical drug DB00160 KYNU -- Failed in clinical trials Details
D545 Pig placenta extract Biological extract -- -- -- Under clinical trials Details