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

Primary Purpose

NAFLD, NASH

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Elobixibat
Placebo oral tablet
Sponsored by
Albireo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NAFLD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hope Clinical Research
  • Inland Empire Clinical Trials, LLC
  • Peak Gastroenterology Associates
  • Integrity Clinical Research, LLC
  • Nature Coast Clinical Research
  • Guardian Angel Research Center, Inc.
  • Mercy Medical Center
  • American Research Corporation at the Texas Liver Institute
  • Virginia Commonwealth University
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Elobixibat

Placebo

Arm Description

Elobixibat 5 mg once daily

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 29, 2019
Last Updated
August 31, 2021
Sponsor
Albireo
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1. Study Identification

Unique Protocol Identification Number
NCT04006145
Brief Title
A Phase 2 Study of Elobixibat in Adults With NAFLD or NASH
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 6, 2019 (Actual)
Primary Completion Date
June 26, 2020 (Actual)
Study Completion Date
July 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albireo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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)
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD, NASH

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double-Blind, Randomized, Placebo-Controlled
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elobixibat
Arm Type
Experimental
Arm Description
Elobixibat 5 mg once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Elobixibat
Other Intervention Name(s)
A3309
Intervention Description
Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Other Intervention Name(s)
Placebo
Intervention Description
Placebo identical in appearance to active drug
Primary Outcome Measure Information:
Title
Change From Baseline in Serum Low Density Lipoprotein-cholesterol (LDL-C) at Week 16
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hope Clinical Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Inland Empire Clinical Trials, LLC
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Integrity Clinical Research, LLC
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Nature Coast Clinical Research
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Guardian Angel Research Center, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
American Research Corporation at the Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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