A Phase 2b Study of Icosabutate in Fatty Liver Disease

• Status: Recruiting
• Trial end date: 2023-01-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NorthSea Therapeutics B.V.

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