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A Phase 2 Study of Elobixibat in Adults With NAFLD or NASH

NCT04006145 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2026-02-05

Study results available
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Summary

Double-blind, randomized, placebo-controlled study to explore the efficacy and safety of elobixibat compared to placebo in adults with NAFLD (nonalcoholic fatty liver disease) or NASH (nonalcoholic steatohepatitis)

Conditions

  • NAFLD
  • NASH

Interventions

DRUG

Elobixibat

Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).

DRUG

Placebo oral tablet

Placebo identical in appearance to active drug

Sponsors & Collaborators

  • Albireo

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-06
Primary Completion
2020-06-26
Completion
2020-07-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04006145 on ClinicalTrials.gov