NAFLDPhase 2NCT04006145

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

A Phase 2 study testing Elobixibat in people with NAFLD and NASH, run by Albireo at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: NAFLD, NASH
What is being tested?: Elobixibat
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 47 participants
Where: 10 sitesUnited States
Study dates: 6 Jun 2019to 15 Jul 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Body mass index (BMI) <25 kg/m2
Fibrosis-4 index (Fib-4) >2.6
Any of the following laboratory abnormalities:
alanine aminotransferase (ALT) >5 × upper limit of normal (ULN) or aspartate aminotransferase (AST) >5 × ULN
International normalized ratio (INR) ≥1.3, unless on anticoagulant therapy
Total bilirubin >ULN, except with an established diagnosis of Gilbert's syndrome

Show all 12Show fewer

Platelet count less than the lower limit of normal (LLN)
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 locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

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

Other trials in United States

About this study

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)

Read the 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.

Conditions: NAFLD, NASH
Being tested: Elobixibat, Placebo oral tablet
Medical subject headings: Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ElobixibatDrug
Also called A3309
Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).
Placebo oral tabletDrug
Also called Placebo
Placebo identical in appearance to active drug

Study groups in NCT04006145
Study group	Role	What they receive
Elobixibat	Experimental	Elobixibat 5 mg once daily Receives: Drug: Elobixibat
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo oral tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Serum Low Density Lipoprotein-cholesterol (LDL-C) at 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.
Measured: Week 16

Secondary outcomes (7)

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in enrolled participant regardless of causal relationship with study drug. An SAE was defined as any AE that, at any dose, resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity, required or prolonged hospitalization, was a congenital anomaly/birth defect or an important medical event. TEAEs were defined as AEs that were new or worsened after the first dose of study drug.
Measured: From first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months
Absolute Change From Baseline to Week 16 in Liver Fat Fraction
The effect of elobixibat on liver steatosis was measured by magnetic resonance imaging (MRI) for liver fat fraction using proton density fat fraction [PDFF]). Baseline was defined as the last non-missing value prior to the first dose of study drug.
Measured: Baseline (Day 1) and Week 16
Absolute Change From Baseline to Week 16 in Total Liver Fat
The effect of elobixibat on liver steatosis was measured by MRI for total liver fat using whole liver fat volume. Baseline was defined as the last non-missing value prior to the first dose of study drug.
Measured: Baseline (Day 1) and Week 16
Change From Baseline to Week 16 in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma-glutamyl Transferase (GGT)
Serum samples were collected at specified timepoints to assess ALT, AST and GGT levels. Baseline was defined as the last non-missing value prior to the first dose of study drug.
Measured: Baseline (Day 1) and Week 16
Change From Baseline to Week 16 in High-density Lipoprotein (HDL) Cholesterol, Non-high-density Lipoprotein Cholesterol and Triglycerides
Blood samples were collected at specified timepoints to assess HDL and non-HDL cholesterol levels and triglycerides. Baseline was defined as the last non-missing value prior to the first dose of study drug.
Measured: Baseline (Day 1) and Week 16
Change From Baseline to Week 16 in Low-density Lipoprotein (LDL) Cholesterol to High-density Lipoprotein Cholesterol Ratio
Blood samples were collected at specified timepoints to assess LDL and HDL cholesterol levels and ratio was obtained. Baseline was defined as the last non-missing value prior to the first dose of study drug.
Measured: Baseline (Day 1) and Week 16
Change From Baseline to Week 16 in Total Bile Acids
Blood samples were collected at specified timepoints to assess total bile acid levels. Baseline was defined as the last non-missing value prior to the first dose of study drug.
Measured: Baseline (Day 1) and Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jun 201915 Jul 2020

First posted5 Jul 2019
Study start6 Jun 2019
Primary completion26 Jun 2020
Study completion15 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NAFLDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Double-Blind, Randomized, Placebo-Controlled
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04006145
Sponsor's protocol ID: A3309-012
Status last verified: Jan 2026
First submitted: 29 Jun 2019
Last updated: 5 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
Active, not recruiting
Target of Suv420h1/2 in Hepatocytes
NAFLD
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Rupatadine in the Treatment of Nonalcoholic Fatty Liver Disease Patients.
NAFLD (Nonalcoholic Fatty Liver Disease)

All NAFLD trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT04006145
Acronym / sponsor ID: A3309-012
Conditions: NAFLD, NASH
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: AlbireoIndustry (pharma, biotech, devices)
Study start: 6 Jun 2019 (actual)
Primary completion: 26 Jun 2020 (actual)
Study completion: 15 Jul 2020 (actual)
First posted: 5 Jul 2019 (actual)
Results: Posted 27 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Double-Blind, Randomized, Placebo-Controlled

Arm	Type	Receives
Elobixibat	Experimental	Drug: ElobixibatElobixibat 5 mg once daily
Placebo	Placebo comparator	Drug: Placebo oral tabletPlacebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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 (12 listed)

Body mass index (BMI) <25 kg/m2
Fibrosis-4 index (Fib-4) >2.6
Any of the following laboratory abnormalities:
Uncontrolled Type 2 diabetes defined as hemoglobin A1c (HbA1c) >9.5%
Clinical hyperthyroidism or hypothyroidism or screening hormone results pointing to thyroid dysfunction.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ElobixibatAlso: A3309Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).	Drug	Elobixibat
Placebo oral tabletAlso: PlaceboPlacebo identical in appearance to active drug	Drug	Placebo

Primary outcome

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

7 secondary outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: From first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months
Absolute Change From Baseline to Week 16 in Liver Fat Fraction
Time frame: Baseline (Day 1) and Week 16
Absolute Change From Baseline to Week 16 in Total Liver Fat
Time frame: Baseline (Day 1) and Week 16
Change From Baseline to Week 16 in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma-glutamyl Transferase (GGT)
Time frame: Baseline (Day 1) and Week 16
Change From Baseline to Week 16 in High-density Lipoprotein (HDL) Cholesterol, Non-high-density Lipoprotein Cholesterol and Triglycerides
Time frame: Baseline (Day 1) and Week 16
Change From Baseline to Week 16 in Low-density Lipoprotein (LDL) Cholesterol to High-density Lipoprotein Cholesterol Ratio
Time frame: Baseline (Day 1) and Week 16
Change From Baseline to Week 16 in Total Bile Acids
Time frame: Baseline (Day 1) and Week 16

Results and safety

Results posted to the registry on 27 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Elobixibat	23	22
Placebo	24	21

Primary outcome: Change From Baseline in Serum Low Density Lipoprotein-cholesterol (LDL-C) at Week 16

Time frame: Week 16. Least squares mean (Standard Error). Unit: "mmol/L"

Measure	Elobixibat n = 23	Placebo n = 24
Value	-0.57 (0.125)	-0.17 (0.134)

Elobixibat vs Placebo: LS-Means Difference: -0.40 (95% CI -0.76 to -0.04), p = 0.029, ANCOVA

Population analysed: The intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study drug.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Elobixibat	0 of 23 (0%)	13 of 23 (56.5%)	0 of 23
Placebo	0 of 24 (0%)	10 of 24 (41.7%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for NAFLD

Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
Active, not recruiting
Target of Suv420h1/2 in Hepatocytes
NAFLD
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Rupatadine in the Treatment of Nonalcoholic Fatty Liver Disease Patients.
NAFLD (Nonalcoholic Fatty Liver Disease)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elobixibat in people with NAFLD and NASH, run by Albireo at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Serum Low Density Lipoprotein-cholesterol (LDL-C) at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04006145.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.