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

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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 
Jun 04, 2020
Completion date 
Jun 27, 2024
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.

Study Locations

United States
Novartis Investigative Site
Recruiting
Los Angeles, 90057
California
United States
Novartis Investigative Site
Recruiting
Miami Lakes, 33014
Florida
United States
Novartis Investigative Site
Recruiting
Saint Petersburg, 33709
Florida
United States
Novartis Investigative Site
Recruiting
Marietta, 30060
Georgia
United States
Novartis Investigative Site
Recruiting
Honolulu, 96814
Hawaii
United States
Novartis Investigative Site
Recruiting
Wichita, 67207
Kansas
United States
Novartis Investigative Site
Recruiting
Morehead City, 28557
North Carolina
United States
Germany
Novartis Investigative Site
Recruiting
Essen, 45136
Nordrhine Westphalia
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Mainz, 55131
-
Germany

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]