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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04006145
Recruitment Status : Active, not recruiting
First Posted : July 5, 2019
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Albireo

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)

Condition or disease Intervention/treatment Phase
NAFLD NASH Drug: Elobixibat Drug: Placebo oral tablet Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-Blind, Randomized, Placebo-Controlled
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 6, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
Experimental: Elobixibat
Elobixibat 5 mg once daily
Drug: Elobixibat
Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).
Other Name: A3309

Placebo Comparator: Placebo
Placebo
Drug: Placebo oral tablet
Placebo identical in appearance to active drug
Other Name: Placebo




Primary Outcome Measures :
  1. Change from baseline in serum low-density lipoprotein cholesterol (LDL-C) at Week 16 [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  1. Absolute change from Baseline to Week 16 in liver fat fraction (%) as measured by MRI-proton density fat fraction (PDFF) [ Time Frame: Week 16 ]
  2. Absolute change from Baseline to Week 16 in total liver fat (mL) as measured by MRI [ Time Frame: Week 16 ]
  3. Change from Baseline to Week 16 in Liver Functions tests [ Time Frame: Week 16 ]
    Liver function tests include alanine aminotransferase (ALT), aspartate aminotransferase (AST) and gamma glutamyltransferase (GGT)

  4. Change from Baseline to Week 16 in Cholesterol profile [ Time Frame: Week 16 ]
    Cholesterol profile includes HDL-C, non-HDL-C, and triglycerides

  5. Change from Baseline to Week 16 in Cholesterol profile [ Time Frame: Week 16 ]
    Cholesterol profile includes LDL-C/HDL-C ratio

  6. Change from Baseline to Week 16 in serum total bile acids [ Time Frame: Week 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Have a current biopsy-confirmed NASH within 6 months of screening or a suspected diagnosis of NAFLD/NASH
  • Screening MRI-PDFF with ≥10% liver steatosis
  • Fasting serum 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. ALT >5 × upper limit of normal (ULN) or 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
  • Patients with known intolerance to MRI or with conditions contraindicated for MRI procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04006145


Locations
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United States, California
Hope Clinical Research
Canoga Park, California, United States, 91303
Inland Empire Clinical Trials, LLC
Rialto, California, United States, 92377
United States, Colorado
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States, 80907
United States, Florida
Integrity Clinical Research, LLC
Doral, Florida, United States, 33166
Nature Coast Clinical Research
Inverness, Florida, United States, 34452
Guardian Angel Research Center, Inc.
Tampa, Florida, United States, 33614
United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
United States, Texas
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States, 78215
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Albireo
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Responsible Party: Albireo
ClinicalTrials.gov Identifier: NCT04006145    
Other Study ID Numbers: A3309-012
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Non-alcoholic Fatty Liver Disease
Fatty Liver
Liver Diseases
Digestive System Diseases