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

Stopped early · Phase 2

Conditions studied: Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis

In brief

This clinical study was designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of various single and combination treatments in adult patients with non-alcoholic fatty liver disease (NAFLD) who manifest a non-alcoholic steatohepatitis (NASH)-like biomarker phenotype.

Key facts

Study ID

NCT04147195

Run by

Novartis Pharmaceuticals

People needed

41

Starts

2020-06-04

Expected to finish

2022-01-06

Last updated by the study team

2023-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Phenotypic diagnosis of NASH based on the presence of all of the following:
• ALT ≥ 43 IU/L (males) or ≥ 28 IU/L (females)
• 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.)

You may not qualify if…

• Use of other investigational drugs within 5 half-lives of randomization or within 3 months, whichever is longer
• Use of obeticholic acid (OCA) or pharmacologically-active weight loss drugs within 1 month of randomization
• Use of strong CYP3A4/5 inhibitors or strong CYP3A4 inducers within 5 half-lives or 7 days of randomization, whichever is longer
• 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
• Use of OAT3 inhibitors within 5 half-lives or 7 days of randomization, whichever is longer

Where it is running

• Novartis Investigative Site — Coronado, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Miami Lakes, Florida, United States
• Novartis Investigative Site — Marietta, Georgia, United States
• Novartis Investigative Site — Honolulu, Hawaii, United States
• Novartis Investigative Site — South Bend, Indiana, United States
• Novartis Investigative Site — Morehead City, North Carolina, United States
• Novartis Investigative Site — San Antonio, Texas, United States
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — Essen, Nordrhine Westphalia, Germany

Full record on ClinicalTrials.gov

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