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

Albireo47 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

NAFLD NASH

Interventions

ElobixibatDRUG

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

Placebo oral tabletDRUG

Placebo identical in appearance to active drug

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: 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

Locations (10)

Hope Clinical Research

Canoga Park, California, United States

Inland Empire Clinical Trials, LLC

Rialto, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Outcomes

Primary Outcomes

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.

Time frame: Week 16

Secondary Outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

An adverse event (AE) was any untoward medical occurrence in enrolled participant regardless of causal relationship with study drug. An SAE was defined as any AE that, at any dose, resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity, required or prolonged hospitalization, was a congenital anomaly/birth defect or an important medical event. TEAEs were defined as AEs that were new or worsened after the first dose of study drug.

Time frame: From first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months

Absolute Change From Baseline to Week 16 in Liver Fat Fraction

The effect of elobixibat on liver steatosis was measured by magnetic resonance imaging (MRI) for liver fat fraction using proton density fat fraction \[PDFF\]). Baseline was defined as the last non-missing value prior to the first dose of study drug.

Time frame: Baseline (Day 1) and Week 16

Absolute Change From Baseline to Week 16 in Total Liver Fat

The effect of elobixibat on liver steatosis was measured by MRI for total liver fat using whole liver fat volume. Baseline was defined as the last non-missing value prior to the first dose of study drug.

Time frame: Baseline (Day 1) and Week 16

Change From Baseline to Week 16 in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma-glutamyl Transferase (GGT)

Data from ClinicalTrials.gov

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