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

NASH EXploratory Single and COmbination Treatment (NEXSCOT): An Open Label, Multicenter, Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Various Single and Combination Treatments in Patients With Non-alcoholic Fatty Liver Disease (NAFLD) Who Manifest a Non-alcoholic Steatohepatitis (NASH)-Like Biomarker Phenotype

ClinicalTrials.gov Identifier: NCT04147195

Novartis Reference Number: CADPT02A12001

Last Update: Mar 30, 2021

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Condition

Non-alcoholic Fatty Liver Disease

Nonalcoholic Steatohepatitis

Phase

Phase 2

Overall status

Recruiting

Enrollment count

250 participants

Start date

Jan 14, 2020

Completion date

May 05, 2025

Gender

All

Age(s)

18 Years and older (Adult, Older Adult)

Interventions

Drug

LYS006

Single treatment with LYS006

Drug

LYS006 + Tropifexor (LJN452)

Combination treatment with LYS006 + Tropifexor (LJN452)

Eligibility 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.