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

NorthSea Therapeutics

Status and phase: Completed; Phase 2

Conditions: Non Alcoholic Steatohepatitis (NASH)

Treatments: Drug: Placebo; Drug: Icosabutate

Study type: Interventional

Funder types: Industry

Identifiers

NCT04052516

NST-02

Details and patient eligibility

About

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

Full 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

Enrollment: 280 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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280 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo oral capsules taken one daily for 52 weeks

Treatment:

Drug: Placebo

Icosabutate 300mg

Experimental group

Description:

Icosabutate 300mg oral capsule taken once daily for 52 weeks

Treatment:

Drug: Icosabutate

Icosabutate 600mg

Experimental group

Description:

Icosabutate 600mg oral capsules taken once daily for 52 weeks

Treatment:

Drug: Icosabutate