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)

Sponsors

Lead Sponsor: Albireo

Source 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)

Overall Status Active, not recruiting
Start Date June 6, 2019
Completion Date July 2020
Primary Completion Date June 2020
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from baseline in serum low-density lipoprotein cholesterol (LDL-C) at Week 16 Week 16
Secondary Outcome
Measure Time Frame
Absolute change from Baseline to Week 16 in liver fat fraction (%) as measured by MRI-proton density fat fraction (PDFF) Week 16
Absolute change from Baseline to Week 16 in total liver fat (mL) as measured by MRI Week 16
Change from Baseline to Week 16 in Liver Functions tests Week 16
Change from Baseline to Week 16 in Cholesterol profile Week 16
Change from Baseline to Week 16 in Cholesterol profile Week 16
Change from Baseline to Week 16 in serum total bile acids Week 16
Enrollment 47
Condition
Intervention

Intervention Type: Drug

Intervention Name: Elobixibat

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

Arm Group Label: Elobixibat

Other Name: A3309

Intervention Type: Drug

Intervention Name: Placebo oral tablet

Description: Placebo identical in appearance to active drug

Arm Group Label: Placebo

Other Name: Placebo

Eligibility

Criteria:

Key Inclusion Criteria:

- Have a current biopsy-confirmed NASH within 6 months of screening or a suspected diagnosis of NAFLD/NASH

- Screening MRI-PDFF with ≥10% liver steatosis

- Fasting serum 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. ALT >5 × upper limit of normal (ULN) or 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

- Patients with known intolerance to MRI or with conditions contraindicated for MRI procedures

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

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

United States

Verification Date

March 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Elobixibat

Type: Experimental

Description: Elobixibat 5 mg once daily

Label: Placebo

Type: Placebo Comparator

Description: Placebo

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Double-Blind, Randomized, Placebo-Controlled

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov