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New drug shows promise for fatty liver – but early days

NCT ID NCT04006145

Disease control Sponsor: Albireo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested elobixibat, a drug that blocks bile acid absorption in the gut, in 47 adults with nonalcoholic fatty liver disease (NAFLD) or its more severe form NASH. Participants received either elobixibat or a placebo for 16 weeks. The main goal was to see if the drug lowered LDL cholesterol. Researchers also tracked side effects. Results are not yet published.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
elobixibat
What this could lead to
If successful, elobixibat could offer a new way to lower cholesterol and improve liver health in people with fatty liver disease.
What could go wrong
This is a small, early-phase trial with only 47 participants. The main focus is on cholesterol levels, not long-term liver outcomes, so benefits may not be clear.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

47 people

The number who actually took part.

Started

Jun 2019

Finished

Jul 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NAFLD NASH

Contacts and locations

Locations

  • American Research Corporation at the Texas Liver Institute

    San Antonio, Texas, 78215, United States

  • Guardian Angel Research Center, Inc.

    Tampa, Florida, 33614, United States

  • Hope Clinical Research

    Canoga Park, California, 91303, United States

  • Inland Empire Clinical Trials, LLC

    Rialto, California, 92377, United States

  • Integrity Clinical Research, LLC

    Doral, Florida, 33166, United States

  • Mercy Medical Center

    Baltimore, Maryland, 21202, United States

  • Nature Coast Clinical Research

    Inverness, Florida, 34452, United States

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

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