A Phase 2b Study of Icosabutate in Fatty Liver Disease
Completed · Phase 2 · Has a placebo group
Conditions studied: Non Alcoholic Steatohepatitis (NASH)
In brief
A Phase 2b study to evaluate the efficacy of different doses of NST-4016 on the resolution of NASH without worsening of fibrosis
Key facts
- Study ID
- NCT04052516
- Run by
- NorthSea Therapeutics B.V.
- People needed
- 280
- Starts
- 2019-07-17
- Expected to finish
- 2022-12-19
- Last updated by the study team
- 2025-02-28
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- 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
Full record on ClinicalTrials.gov
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