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Completed

NCT Number: NCT04052516

A Phase 2b Study of Icosabutate in Fatty Liver Disease

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

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Key information

Conditions

Non Alcoholic Steatohepatitis (NASH) Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fundacion de Investigacion (FDI), San Juan, Puerto Rico

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Icosabutate

Drug

Icosabutate oral capsule once daily

Other names: NST-4016

Placebo

Drug

Matching placebo oral capsule

Primary outcomes

  1. 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.

    Time frame: 52 weeks

Secondary outcomes

  1. 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).

    Time frame: 52 weeks

  2. Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement.

    Time frame: 52 weeks

  3. Changes in the Liver Enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L From Baseline

    Time frame: 52 weeks

  4. Change in Bilirubin Micromol/L From Baseline

    Time frame: 52 weeks

  5. Change From Baseline in Inflammation Marker hsCRP

    Time frame: 52 weeks

  6. Change From Baseline in Fibrosis Activity Marker Pro-C3

    Time frame: 52 weeks

  7. Change From Baseline in Fibrosis Activity Marker Enhanced Liver Fibrosis (ELF) Test

    Time frame: 52 weeks

    ELF is a blood test that measures liver fibrosis by analyzing three markers in the blood: Hyaluronic acid (HA), Procollagen III amino-terminal peptide (PIIINP), and Tissue inhibitor of matrix metalloproteinase 1 (TIMP-1). The higher the score the higher the levels of markers in the blood. ELF score = 2.278 + 0.851 × ln(HA) + 0.751 × ln(PIIINP) + 0.394 × ln(TIMP-1). As the score is a composite measure of the levels of three markers in the blood, there is not a finite range for this parameter.

  8. Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    Time frame: 52 weeks

    HOMA-IR is a measure of insulin resistance and metabolic status. The higher the score, the higher the level of insulin resistance. HOMA-IR = fasting glucose [mmol/L)] × fasting insulin [mIU/L]/22.5. As HOMA-IR is a composite score using 2 parameters, it does not have a finite range.

  9. Change From Baseline in Composite Disease Activity Score (Composite NASH Score of Inflammation, Ballooning, Fibrosis)

    Time frame: 52 weeks

    The disease activity score can range from 0 to 8 and is calculated by the sum of scores of steatosis (0-3), lobular inflammation (0-3) and hepatocyte ballooning (0-2). The higher the score the more severe the disease.

  10. Change From Baseline in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)

    Time frame: 52 weeks

    A histological scoring system that assesses a liver biopsy and gives scores for steatosis (0-3), lobular inflammation (0-3), and hepatocyte ballooning (0-2) giving a total score of (0-8). The higher the score the more severe the disease

  11. Changes in Individual Histological Scores for Steatosis, Ballooning, Inflammation, and Fibrosis From Baseline

    Time frame: 52 weeks

    Changes in scores for the individual component parts of the Nonalcoholic fatty liver disease (NAFLD) activity score (NAS) as judged by a pathologist examining sections from a liver biopsy; steatosis (range 0-3), lobular inflammation (range 0-3), and hepatocyte ballooning (range 0-2) In all cases a higher number denotes more severe disease activity

  12. Change From Baseline in Magnetic Resonance Imaging-Proton Density-Fat Fraction (MRI-PDFF)

    Time frame: 52 weeks

    MRI-PDFF is a quantitative imaging biomarker that measures the fat fraction of tissue by correcting factors influencing magnetic resonance signal intensity.

Sponsors and collaborators

Lead sponsor

NorthSea Therapeutics B.V.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of NST-4016 in Patients With Nonalcoholic Steatohepatitis (NASH)

Acronym: ICONA

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2019
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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