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

NAFLD Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04006145
• Other study ID #: A3309-012
• Status: Completed
• Phase: Phase 2
• Start date: June 6, 2019
• Est. completion date: July 15, 2020

Study information

• Verified date: August 2021
• Source: Albireo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 15, 2020
• Est. primary completion date: June 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• NAFLD
• NASH
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• Elobixibat
Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).
• Placebo oral tablet
Placebo identical in appearance to active drug

Locations

Country	Name	City	State
United States	Mercy Medical Center	Baltimore	Maryland
United States	Hope Clinical Research	Canoga Park	California
United States	Peak Gastroenterology Associates	Colorado Springs	Colorado
United States	Integrity Clinical Research, LLC	Doral	Florida
United States	Nature Coast Clinical Research	Inverness	Florida
United States	Inland Empire Clinical Trials, LLC	Rialto	California
United States	Virginia Commonwealth University	Richmond	Virginia
United States	American Research Corporation at the Texas Liver Institute	San Antonio	Texas
United States	University of Washington	Seattle	Washington
United States	Guardian Angel Research Center, Inc.	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Albireo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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