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

Phase 2

Completed

• Conditions: NAFLD; NASH
• Interventions: Drug: Placebo oral tablet; Drug: Elobixibat

• Registration Number: NCT04006145
• Lead Sponsor: 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)

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 Timeline

• Study Start: 2019-06-06
• Study First Submitted: 2019-06-29
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-05
• Primary Completion: 2020-06-26
• Study Completion: 2020-07-15
• Status Verified: 2021-08
• Results First Submitted: 2021-08-04
• Results First Submitted QC: 2021-08-31
• Last Update Submitted: 2021-08-31
• Results First Posted: 2021-09-27
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo oral tablet	Placebo
Elobixibat	Elobixibat	Elobixibat 5 mg once daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Serum Low Density Lipoprotein-cholesterol (LDL-C) at Week 16	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.

Trial Locations

Locations (10)

Integrity Clinical Research, LLC; 🇺🇸 Doral, Florida, United States

Mercy Medical Center; 🇺🇸 Baltimore, Maryland, United States

American Research Corporation at the Texas Liver Institute; 🇺🇸 San Antonio, Texas, United States

Hope Clinical Research; 🇺🇸 Canoga Park, California, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

Inland Empire Clinical Trials, LLC; 🇺🇸 Rialto, California, United States

Peak Gastroenterology Associates; 🇺🇸 Colorado Springs, Colorado, United States

Guardian Angel Research Center, Inc.; 🇺🇸 Tampa, Florida, United States

Nature Coast Clinical Research; 🇺🇸 Inverness, Florida, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States