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

Albireo

Status and phase: Completed; Phase 2

Conditions: NASH; NAFLD

Treatments: Drug: Placebo oral tablet; Drug: Elobixibat

Study type: Interventional

Funder types: Industry

Identifiers

NCT04006145

A3309-012

Details and patient eligibility

About

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)

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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47 participants in 2 patient groups, including a placebo group

Elobixibat

Experimental group

Description:

Elobixibat 5 mg once daily

Treatment:

Drug: Elobixibat

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo oral tablet