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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04147195
Recruitment Status : Recruiting
First Posted : November 1, 2019
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis Drug: LYS006 Drug: LYS006 + Tropifexor (LJN452) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 4, 2020
Estimated Primary Completion Date : June 27, 2024
Estimated Study Completion Date : June 27, 2024


Arm Intervention/treatment
Experimental: Cohort 1, Arm 1
LYS006
Drug: LYS006
Single treatment with LYS006

Experimental: Cohort 1, Arm 2
LYS006 + Tropifexor (LJN452)
Drug: LYS006 + Tropifexor (LJN452)
Combination treatment with LYS006 + Tropifexor (LJN452)




Primary Outcome Measures :
  1. Number of Participants with Treatment Related Adverse Events, Serious Adverse Events and Deaths [ Time Frame: Up to 21 weeks after first dose ]
    Analysis of absolute and relative frequencies for treatment emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths by primary System Organ Class (SOC), and monitoring of relevant clinical and laboratory safety parameters to demonstrate the safety and tolerability of single or combination therapy in patients with non-alcoholic fatty liver disease (NAFLD) who have characteristics of non-alcoholic steatohepatitis (NASH).


Secondary Outcome Measures :
  1. Change from Baseline in Enhanced Liver Fibrosis (ELF) [ Time Frame: Week 12 ]
    The Enhanced Liver Fibrosis (ELF) Test will be examined as a measure of liver fibrosis

  2. Change from Baseline in percent liver fat [ Time Frame: Week 12 ]
    Intrahepatic lipid content (percent liver fat) will be examined by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) as a measure of liver fat

  3. Change from Baseline in fasting lipid profile [ Time Frame: Week 12 ]
    Fasting lipid profile will be examined as a cardiometabolic risk parameter

  4. Change from Baseline in Alanine aminotransferase (ALT) [ Time Frame: Week 12 ]
    Liver function tests (ALT) will be examined as measures of liver inflammation

  5. Determine the Area Under the Curve (AUC) of treatments [ Time Frame: Up to 21 weeks after first dose ]
    AUC will be examined as a measure of the pharmacokinetics of the treatments

  6. Determine the minimum concentration (Cmin) of treatments [ Time Frame: Up to 21 weeks after first dose ]
    Cmin will be examined as a measure of the pharmacokinetics of the treatments

  7. Determine the maximum concentration (Cmax) of treatments [ Time Frame: Up to 21 weeks after first dose ]
    Cmax will be examined as a measure of the pharmacokinetics of the treatments

  8. Determine the time to reach the maximum concentration (Tmax) for the treatments [ Time Frame: Up to 21 weeks after first dose ]
    Tmax will be examined as a measure of the pharmacokinetics of the treatments



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04147195


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, California
Novartis Investigative Site Recruiting
Los Angeles, California, United States, 90057
United States, Florida
Novartis Investigative Site Recruiting
Miami Lakes, Florida, United States, 33014
Novartis Investigative Site Recruiting
Saint Petersburg, Florida, United States, 33709
United States, Georgia
Novartis Investigative Site Recruiting
Marietta, Georgia, United States, 30060
United States, Hawaii
Novartis Investigative Site Recruiting
Honolulu, Hawaii, United States, 96814
United States, Kansas
Novartis Investigative Site Recruiting
Wichita, Kansas, United States, 67207
United States, North Carolina
Novartis Investigative Site Recruiting
Morehead City, North Carolina, United States, 28557
Germany
Novartis Investigative Site Recruiting
Essen, Nordrhine Westphalia, Germany, 45136
Novartis Investigative Site Recruiting
Dresden, Germany, 01307
Novartis Investigative Site Recruiting
Mainz, Germany, 55131
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04147195    
Other Study ID Numbers: CADPT02A12001
2018-002692-17 ( EudraCT Number )
First Posted: November 1, 2019    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Non-alcoholic fatty liver disease
NAFLD
Non-alcoholic steatohepatitis
NASH
Platform design
LYS006
LJN452
Tropifexor
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases