Clinical trial NCT04006145: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: NAFLD
NASH
Lead sponsor: AlbireoPharma
Sponsor class: UNKNOWN
First posted: 2019-07-05
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-Blind, Randomized, Placebo-Controlled
Primary purpose: TREATMENT

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.

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:

  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

Primary outcomes:
measure: Change From Baseline in Serum Low Density Lipoprotein-cholesterol (LDL-C) at Week 16
timeFrame: Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Rialto
country: United States
facility: Inland Empire Clinical Trials, LLC
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Doral
country: United States
facility: Integrity Clinical Research, LLC
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Tampa
country: United States
facility: Guardian Angel Research Center, Inc.
state: Florida
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: San Antonio
country: United States
facility: American Research Corporation at the Texas Liver Institute
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References: