NCT04235205

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

Efficacy and Safety of Elobixibat in Combination With Cholestyramine for Patients With Nonalcoholic Fatty Liver Disease: a Single Center, Double-blind, Randomized, Placebo-Controlled, Phase 2a Trial.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Yokohama City University · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a placebo-controlled, randomized, double-blind, parallel group, comparative study, when patients with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH), are administered elobixibat at 10 mg and cholestyramine powder at 9g( cholestyramine 4g) once daily for 16 weeks.

Conditions

• Nonalcoholic Fatty Liver
• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-01-29
• Primary completion: 2021-07-21
• Completion: 2021-09-30
• First posted: 2020-01-21
• Last updated: 2021-11-16

Locations

1 site across 1 country: Japan