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

NCT04006145 | Completed Phase 2 Results FDA Drug

• 1 other identifier: A3309-012
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 10

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)

Conditions

NAFLD; NASH

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

  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

  Baseline (Day 1) and Week 16

• Absolute Change From Baseline to Week 16 in Total Liver Fat

  Baseline (Day 1) and Week 16

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

  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

  Baseline (Day 1) and Week 16

Study Arms (2)

Elobixibat

EXPERIMENTAL

Elobixibat 5 mg once daily

Drug: Elobixibat

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo oral tablet

Interventions

Elobixibat DRUG

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

Also known as: A3309

Elobixibat

Placebo oral tablet DRUG

Placebo identical in appearance to active drug

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albireo: lead

Study Sites (10)

Hope Clinical Research

Canoga Park, California, 91303, United States

Location

Inland Empire Clinical Trials, LLC

Rialto, California, 92377, United States

Location

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907, United States

Location

Integrity Clinical Research, LLC

Doral, Florida, 33166, United States

Location

Nature Coast Clinical Research

Inverness, Florida, 34452, United States

Location

Guardian Angel Research Center, Inc.

Tampa, Florida, 33614, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

American Research Corporation at the Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

elobixibat

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Patrick Horn, MD, PhD
• Organization: Albireo AB

medinfo@albireopharma.com

+1 (857) 378- 2035

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-Blind, Randomized, Placebo-Controlled

Study Record Dates

• First Submitted: June 29, 2019
• First Posted: July 5, 2019
• Study Start: June 6, 2019
• Primary Completion: June 26, 2020
• Study Completion: July 15, 2020
• Last Updated: February 5, 2026
• Results First Posted: September 27, 2021

Record last verified: 2026-01

Locations

US (10)