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

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)

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)

Study Overview

• Status: Completed
• Conditions: NAFLD; NASH
• Intervention / Treatment: Drug: Elobixibat; Drug: Placebo oral tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Canoga Park, California, United States, 91303
      • HOPE Clinical Research
    • Rialto, California, United States, 92377
      • Inland Empire Clinical Trials, LLC
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Peak Gastroenterology Associates
  • Florida
    • Doral, Florida, United States, 33166
      • Integrity Clinical Research, LLC
    • Inverness, Florida, United States, 34452
      • Nature Coast Clinical Research
    • Tampa, Florida, United States, 33614
      • Guardian Angel Research Center, Inc.
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Mercy Medical Center
  • Texas
    • San Antonio, Texas, United States, 78215
      • American Research Corporation at the Texas Liver Institute
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo oral tablet; Placebo identical in appearance to active drug; Other Names: Placebo
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 Names: A3309

What is the study measuring?

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline (Day 1) and Week 16
Change From Baseline to Week 16 in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma-glutamyl Transferase (GGT)	Serum samples were collected at specified timepoints to assess ALT, AST and GGT levels. Baseline was defined as the last non-missing value prior to the first dose of study drug.	Baseline (Day 1) and Week 16
Change From Baseline to Week 16 in High-density Lipoprotein (HDL) Cholesterol, Non-high-density Lipoprotein Cholesterol and Triglycerides	Blood samples were collected at specified timepoints to assess HDL and non-HDL cholesterol levels and triglycerides. Baseline was defined as the last non-missing value prior to the first dose of study drug.	Baseline (Day 1) and Week 16
Change From Baseline to Week 16 in Low-density Lipoprotein (LDL) Cholesterol to High-density Lipoprotein Cholesterol Ratio	Blood samples were collected at specified timepoints to assess LDL and HDL cholesterol levels and ratio was obtained. Baseline was defined as the last non-missing value prior to the first dose of study drug.	Baseline (Day 1) and Week 16
Change From Baseline to Week 16 in Total Bile Acids	Blood samples were collected at specified timepoints to assess total bile acid levels. Baseline was defined as the last non-missing value prior to the first dose of study drug.	Baseline (Day 1) and Week 16

Collaborators and Investigators

• Sponsor: Albireo

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2019
• Primary Completion (Actual): June 26, 2020
• Study Completion (Actual): July 15, 2020

Study Registration Dates

• First Submitted: June 29, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; elobixibat
• Other Study ID Numbers: A3309-012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No