Study of Various Treatments in Non-alcoholic Fatty Liver Disease (NAFLD) Patients Who Have Aspects of Non-alcoholic Steatohepatitis (NASH)

• Status: Recruiting
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: All

Summary

This study will look at how different single and combination study treatments will work in adults with non-alcoholic fatty liver disease (NAFLD) who have features of non-alcoholic steatohepatitis (NASH). The study will see if the treatments are safe and see if they can improve NAFLD.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Phenotypic diagnosis of NASH based on the presence of all of the following:

• ALT ≥ 43 IU/L (males) or ≥ 28 IU/L (females) at screening

• BMI ≥ 27 kg/m2 (race other than Asian) or ≥ 23 kg/m2 (Asian race)

• History of type 2 diabetes mellitus with HbA1c ≤ 9%

• ELF test score ≥ 8.5 and ≤ 10.5

• Liver fat ≥ 8%

• Patients must weigh between 40 kg (88 lbs.) and 150 kg (330 lbs.)

Exclusion Criteria:

• Use of other investigational drugs within 5 half-lives of enrollment or within 3 months, whichever is longer

• Use of obeticholic acid (OCA) or pharmacologically-active weight loss drugs within 1 month of enrollment and until end-of-study

• Use of strong CYP3A4/5 inhibitors or strong CYP3A4 inducers within 5 half-lives or 7 days of enrollment, whichever is longer, and until end-of-study

• History or presence of other concomitant liver diseases

• History or current diagnosis of ECG abnormalities

• Patients with contraindications to MRI imaging

• Current or history of significant alcohol consumption

• Clinical evidence of hepatic decompensation or severe liver impairment

• Women of child bearing potential (unless on highly effective methods of contraception)

• Presence of liver cirrhosis

• For Cohort 1, use of OAT3 inhibitors or BRCP inhibitors within 5 half-lives or 7 days of enrollment, whichever is longer and until the end of study.