Phase 2 N=280 Randomized Quadruple-blind Treatment

A Phase 2b Study of Icosabutate in Fatty Liver Disease

Non Alcoholic Steatohepatitis (NASH)

Bottom Line

View on ClinicalTrials.gov: NCT04052516 ↗

Enrolled (actual)

280

Serious AEs

6.1%

Results posted

Feb 2025

Primary outcome: Primary: 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. — 8.7; 17.3; 20.8 percentage of participants — p=0.2991

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Icosabutate (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: NorthSea Therapeutics B.V.
Primary completion: Feb 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY 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.	8.7; 17.3; 20.8	0.2991
SECONDARY 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).	13.0; 26.9; 24.5	—
SECONDARY Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement.	13.0; 30.8; 28.3	—
SECONDARY Changes in the Liver Enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L From Baseline	-8.2; -14.9; -18.5; -9.8; -27.9; -30.1	—
SECONDARY Change in Bilirubin Micromol/L From Baseline	0.56; -1.11; -1.49	—
SECONDARY Change From Baseline in Inflammation Marker hsCRP	1.089; -1.297; -3.382	—
SECONDARY Change From Baseline in Fibrosis Activity Marker Pro-C3	-4.33; -3.68; -11.76	—
SECONDARY Change From Baseline in Fibrosis Activity Marker Enhanced Liver Fibrosis (ELF) Test	-0.051; -0.125; -0.370	—
SECONDARY Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)	0.609; -2.810; -3.794	—
SECONDARY Change From Baseline in Composite Disease Activity Score (Composite NASH Score of Inflammation, Ballooning, Fibrosis)	-0.2; -0.7; -0.9	—
SECONDARY Change From Baseline in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)	-0.9; -0.9; -1.3	—
SECONDARY Changes in Individual Histological Scores for Steatosis, Ballooning, Inflammation, and Fibrosis From Baseline	-0.4; -0.2; -0.4; -0.2; -0.4; -0.5	—
SECONDARY Change From Baseline in Magnetic Resonance Imaging-Proton Density-Fat Fraction (MRI-PDFF)	-4.37; -1.33; -0.95	—

Summary

A Phase 2b study to evaluate the efficacy of different doses of NST-4016 on the resolution of NASH without worsening of fibrosis

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04052516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.