Status:
COMPLETED
A Phase 2b Study of Icosabutate in Fatty Liver Disease
Lead Sponsor:
NorthSea Therapeutics B.V.
Conditions:
Non Alcoholic Steatohepatitis (NASH)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2022
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT04052516
Start Date
July 17 2019
End Date
December 19 2022
Last Update
February 28 2025
Active Locations (39)
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1
Central ResearchAssociates Inc.
Birmingham, Alabama, United States, 35205
2
Arizona Liver Health
Chandler, Arizona, United States, 85224
3
Arizona Liver Health - Glendale
Glendale, Arizona, United States, 85306
4
Arizona Liver Health
Tucson, Arizona, United States, 85711