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A Phase 2b Study of Icosabutate in Fatty Liver Disease (ICONA)

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ClinicalTrials.gov Identifier: NCT04052516
Recruitment Status : Recruiting
First Posted : August 9, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
NorthSea Therapeutics B.V.

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

Condition or disease Intervention/treatment Phase
Non Alcoholic Steatohepatitis (NASH) Drug: Icosabutate Drug: Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of NST-4016 in Patients With Nonalcoholic Steatohepatitis (NASH)
Actual Study Start Date : July 17, 2019
Estimated Primary Completion Date : July 5, 2021
Estimated Study Completion Date : September 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo oral capsules taken one daily for 52 weeks
Drug: Placebo
Matching placebo oral capsule

Experimental: Icosabutate 300mg
Icosabutate 300mg oral capsule taken once daily for 52 weeks
Drug: Icosabutate
Icosabutate oral capsule once daily
Other Name: NST-4016

Experimental: Icosabutate 600mg
Icosabutate 600mg oral capsules taken once daily for 52 weeks
Drug: Icosabutate
Icosabutate oral capsule once daily
Other Name: NST-4016




Primary Outcome Measures :
  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 Outcome Measures :
  1. 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

  2. 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

  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 mg/dL from baseline [ Time Frame: 52 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052516


Contacts
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Contact: Clinical Trial Manager 1.800.730.5779 icona@medpace.com

  Show 30 Study Locations
Sponsors and Collaborators
NorthSea Therapeutics B.V.

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Responsible Party: NorthSea Therapeutics B.V.
ClinicalTrials.gov Identifier: NCT04052516     History of Changes
Other Study ID Numbers: NST-02
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases