Overview

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.