Clinical trial NCT04052516: A Phase 2b Study of Icosabutate in Fatty Liver Disease
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of NST-4016 in Patients With Nonalcoholic Steatohepatitis (NASH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Alcoholic Steatohepatitis (NASH)
Lead sponsor: NorthSea Therapeutics B.V.
Sponsor class: INDUSTRY
First posted: 2019-08-09
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. The study includes a screening period, double blind treatment period, and post-treatment follow up

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: 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.
timeFrame: 52 weeks
Secondary outcomes:
measure: 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).
timeFrame: 52 weeks
measure: Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement.
timeFrame: 52 weeks
measure: Changes in the Liver Enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L From Baseline
timeFrame: 52 weeks
measure: Change in Bilirubin Micromol/L From Baseline
timeFrame: 52 weeks
measure: Change From Baseline in Inflammation Marker hsCRP
timeFrame: 52 weeks
measure: Change From Baseline in Fibrosis Activity Marker Pro-C3
timeFrame: 52 weeks
measure: Change From Baseline in Fibrosis Activity Marker Enhanced Liver Fibrosis (ELF) Test
timeFrame: 52 weeks
measure: Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: 52 weeks
measure: Change From Baseline in Composite Disease Activity Score (Composite NASH Score of Inflammation, Ballooning, Fibrosis)
timeFrame: 52 weeks
measure: Change From Baseline in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)
timeFrame: 52 weeks
measure: Changes in Individual Histological Scores for Steatosis, Ballooning, Inflammation, and Fibrosis From Baseline
timeFrame: 52 weeks
measure: Change From Baseline in Magnetic Resonance Imaging-Proton Density-Fat Fraction (MRI-PDFF)
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central ResearchAssociates Inc.
state: Alabama
city: Chandler
country: United States
facility: Arizona Liver Health
state: Arizona
city: Glendale
country: United States
facility: Arizona Liver Health - Glendale
state: Arizona
city: Tucson
country: United States
facility: Arizona Liver Health
state: Arizona
city: Tucson
country: United States
facility: Adobe Clinical Research, LLC
state: Arizona
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology - North Little Rock
state: Arkansas
city: Fresno
country: United States
facility: Fresno Clinical Research Center
state: California
city: Huntington Park
country: United States
facility: National Research Institute - Huntington Park
state: California
city: Los Angeles
country: United States
facility: National Research Institute - Wilshire
state: California
city: Panorama City
country: United States
facility: National Research Institute - Panorama
state: California
city: Poway
country: United States
facility: Alliance Clinical Research
state: California
city: Santa Ana
country: United States
facility: National Research Institute - Santa Ana
state: California
city: Englewood
country: United States
facility: South Denver Gastroenterology
state: Colorado
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials, LLC
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare LLC
state: Florida
city: Sarasota
country: United States
facility: Covenant Research LLC
state: Florida
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia PC
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baton Rouge
country: United States
facility: Texas Digestive Disease Consultants
state: Louisiana
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Flowood
country: United States
facility: Gastrointestinal Associates, PA
state: Mississippi
city: Jackson
country: United States
facility: Southern Therapy and Advanced Research LLC
state: Mississippi
city: Kansas City
country: United States
facility: Kansas City Research Institute
state: Missouri
city: Fayetteville
country: United States
facility: Cumberland Research Associates, LLC
state: North Carolina
city: Columbus
country: United States
facility: Aventiv Research, Inc.
state: Ohio
city: Clarksville
country: United States
facility: Premier Research
state: Tennessee
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Austin
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: Dallas
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Edinburg
country: United States
facility: South Texas Research Institute
state: Texas
city: Houston
country: United States
facility: Liver Associates of Texas
state: Texas
city: McAllen
country: United States
facility: Doctors Hospital at Renaissance, LLC
state: Texas
city: San Antonio
country: United States
facility: Quality Research Inc
state: Texas
city: San Antonio
country: United States
facility: American Research Corporation
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Webster
country: United States
facility: Texas Digestive Disease Consultants - Webster
state: Texas
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion (FDI)
Study officials:
References: