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

Study Overview
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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)

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.

Official Title
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A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Explore the Efficacy and Safety of Elobixibat in Adults With Nonalcoholic Fatty Liver Disease (NAFLD) or Nonalcoholic Steatohepatitis (NASH)

Conditions
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NAFLD, NASH

Intervention / Treatment
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* Drug: Elobixibat
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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Key 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 Key Exclusion Criteria: Body mass index (BMI) <25 kg/m2 Fibrosis-4 index (Fib-4) >2.6 Any of the following laboratory abnormalities: alanine aminotransferase (ALT) >5 × upper limit of normal (ULN) or aspartate aminotransferase (AST) >5 × ULN International normalized ratio (INR) ≥1.3, unless on anticoagulant therapy Total bilirubin >ULN, except with an established diagnosis of Gilbert's syndrome Platelet count less than the lower limit of normal (LLN) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-Blind, Randomized, Placebo-Controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elobixibat<br>Elobixibat 5 mg once daily | Drug: Elobixibat<br>* Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).<br>* Other names: A3309;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo oral tablet<br>* Placebo identical in appearance to active drug<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Serum Low Density Lipoprotein-cholesterol (LDL-C) at Week 16 | The primary efficacy endpoint was the change from Baseline in serum LDL-C at Week 16. Baseline was defined as the last non-missing LDL-C value prior to the first dose of study drug. | Week 16 |