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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-06

Study Completion Date

2020-07-15

Brief Summary

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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)

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Detailed Description

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A total of 15 investigators at 15 sites received institutional review board (IRB)/ethics committee (EC) approval to participate in this study and enrolled at least 1 participant.

Conditions

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NAFLD NASH

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-Blind, Randomized, Placebo-Controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Elobixibat

Elobixibat 5 mg once daily

Group Type EXPERIMENTAL

Elobixibat

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

Placebo identical in appearance to active drug

Interventions

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Elobixibat

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

Intervention Type DRUG

Placebo oral tablet

Placebo identical in appearance to active drug

Intervention Type DRUG

Other Intervention Names

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A3309 Placebo

Eligibility Criteria

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Inclusion Criteria

* Have a current biopsy-confirmed NASH within 6 months of screening or a suspected diagnosis of NAFLD/NASH
* Screening magnetic resonance imaging-proton density fat fraction (MRI-PDFF) with ≥10% liver steatosis
* Fasting serum low density lipoprotein-cholesterol (LDL-C) \>130 mg/dL at Screening, \>110 mg/dL on lipid-lowering medications

Exclusion Criteria

* Body mass index (BMI) \<25 kg/m2
* Fibrosis-4 index (Fib-4) \>2.6
* Any of the following laboratory abnormalities:

1. alanine aminotransferase (ALT) \>5 × upper limit of normal (ULN) or aspartate aminotransferase (AST) \>5 × ULN
2. International normalized ratio (INR) ≥1.3, unless on anticoagulant therapy
3. Total bilirubin \>ULN, except with an established diagnosis of Gilbert's syndrome
4. Platelet count less than the lower limit of normal (LLN)
5. Creatinine clearance as calculated by the modification of diet in renal disease (MDRD) estimated glomerular filtration rate (eGFR) equation \<60 mL/min
* Uncontrolled Type 2 diabetes defined as hemoglobin A1c (HbA1c) \>9.5%
* Clinical hyperthyroidism or hypothyroidism or screening hormone results pointing to thyroid dysfunction.
* Uncontrolled hypertension
* Participants with known intolerance to MRI or with conditions contraindicated for MRI procedures

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No