MedTrace Logo

Efficacy and Safety of Elobixibat in Combination With Cholestyramine for Nonalcoholic Fatty Liver Disease

NCT04235205 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2021-11-16

No results posted yet for this study

Summary

The objective is to evaluate the efficacy and safety of once-daily oral doses of 10 mg elobixibat in combination with 9g cholestyramine powder (cholestyramine 4g) in patients with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH).

Conditions

Interventions

DRUG

Elobixibat 10mg + cholestyramine powder 9g (cholestyramine 4g)

Patients with nonalcoholic fatty liver disease are administered Elobixibat 10mg + cholestyramine powder 9g (cholestyramine 4g) for 16 weeks

DRUG

Elobixibat 10mg + cholestyramine powder placebo

Patients with nonalcoholic fatty liver disease are administered Elobixibat 10mg+ cholestyramine powder placebo for 16 weeks

DRUG

Elobixibat placebo + cholestyramine powder 9g (cholestyramine 4g)

Patients with nonalcoholic fatty liver disease are administered Elobixibat placebo+ cholestyramine powder 9g (cholestyramine 4g) for 16 weeks

DRUG

Elobixibat placebo + cholestyramine powder placebo

Patients with nonalcoholic fatty liver disease are administered Elobixibat placebo+ cholestyramine powder placebo for 16 weeks

Sponsors & Collaborators

  • EA Pharma Co., Ltd.

    collaborator INDUSTRY

  • Yokohama City University

    lead OTHER

Principal Investigators

  • Takaomi Kessoku, MD.,PhD. · Yokohama City University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-29
Primary Completion
2021-07-21
Completion
2021-09-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04235205 on ClinicalTrials.gov