Trial intelligence / Profile preview

Elobixibat and Cholestyramine in NAFLD/NASH

NCT04235205Phase 2

Key facts

Status: Completed
Start: Jan 2020
Primary completion: Jul 2021
Countries: 1
Sponsor: Yokohama City University
Modality: Small Molecules

Drugs: elobixibat
Conditions: non-alcoholic fatty liver disease (NAFLD)Nonalcoholic steatohepatitis (NASH)

Overview

Phase 2, randomised, double-blind trial of elobixibat in non-alcoholic fatty liver disease (NAFLD) and Nonalcoholic steatohepatitis (NASH) (4 arms), sponsored by Yokohama City University. Primary endpoint: Serum Low Density Lipoprotein-Cholesterol at 16 weeks. Started Jan 2020; status: completed.

Design

4 arms

Study design: RandomizedDouble-blind

Elobixibat + Cholestyramine
Elobixibat 10mg + Cholestyramine 4g (9g powder)
Elobixibat Monotherapy
Elobixibat 10mg + Placebo powder
Cholestyramine Monotherapy
Placebo tablet + Cholestyramine 4g (9g powder)
Placebo
Placebo tablet + Placebo powder

Who it enrols

Adult patients aged 20-75 with biopsy-confirmed NASH or suspected NAFLD/NASH based on clinical criteria (elevated enzymes, waist circumference, metabolic syndrome risk factors) and MRI-PDFF >= 8%. Excludes patients with other liver diseases, cirrhosis, significant alcohol consumption, or uncontrolled diabetes/hypertension.

Endpoints

Primary

Serum Low Density Lipoprotein-Cholesterol16 weeks

Secondary

Liver Fat Fraction by MRI-PDFF16 weeks
Hepatic Fibrosis by MRE16 weeks
Alanine Aminotransferase16 weeks
Aspartate Aminotransferase16 weeks
Gamma-Glutamyl Transferase16 weeks
High Density Lipoprotein-Cholesterol16 weeks
Non-High Density Lipoprotein-Cholesterol16 weeks
LDL-C/HDL-C Ratio16 weeks

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