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New pill aims to reverse liver scarring in fatty liver patients

NCT ID NCT07610837

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 02, 2026 · Updated 6 times

Summary

This study tests an experimental drug called AZD2389 in about 104 adults with fatty liver disease and advanced liver scarring (fibrosis). The drug is a pill that blocks a protein linked to scarring. Researchers will check if it safely lowers markers of liver damage over 24 weeks compared to a placebo. The goal is to see if the drug can improve liver health and potentially slow or reverse the disease.

What this could mean

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

Active substance
AZD2389 (an oral drug that blocks a protein called FAP to reduce liver scarring)
What this could lead to
If successful, this could point toward a new treatment to slow or reverse liver scarring in people with fatty liver disease and advanced fibrosis.
What could go wrong
This is an early Phase 2 trial with only 104 participants, so results may not apply to everyone. The drug may not improve liver fibrosis or could cause side effects.

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

About 104 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

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: * Males/females aged 18 or over * A diagnosis of SLD with advanced fibrosis * No significant change in weight over the last 6 months * Contraceptive us by participants or participants partners * Capable of giving informed consent * Judged by the investigator to be suitable for study Key Exclusion Criteria: * Portal hypertension (LSM \>25 kPa or 20-25 kPa with platelets \<150×10⁹/L), decompensated liver disease, Child-Pugh \>A6, MELD \>12, other chronic liver diseases, prior/planned liver transplant, or malignant liver tumors. * Positive viral infections, including HIV or hepatitis B, or hepatitis C unless HCV RNA-negative ≥12 weeks after treatment. * Alcohol intake above protocol thresholds, or positive screen for drugs of abuse. * Significant metabolic, cardiovascular, or GI disorders, including T1DM or insulin-treated T2DM, uncontrolled hypertension, recent major cardiac/cerebrovascular events, severe heart failure, serious arrhythmias, significant pancreatic disease, or major GI surgery. * History of psychosis, bipolar disorder, recent major depression, or suicide attempt/ideation within 1 year. * Bleeding risk or wound-healing concerns, including coagulation disorders, major bleeding history, active wounds or recent major surgery, or severe dermatologic immune conditions. * Prohibited medications or hypersensitivities, including moderate/strong CYP3A4 or BCRP/OAT3 inhibitors/inducers, anticoagulants/antiplatelets (except aspirin ≤81 mg/day), or hypersensitivity to DPP4 inhibitors. * Other protocol-defined exclusions, including significant abnormal labs (e.g., worsening ALT/AST), recent participation in another IMP study, or investigator judgment of unsuitability.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver fibrotic liver disease

As listed by the trial registrant

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

Hepatic cirrhosis Liver fibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Chandler, Arizona, 85224, United States

  • Research Site

    RECRUITING

    Tucson, Arizona, 85712, United States

  • Research Site

    RECRUITING

    Jupiter, Florida, 33458, United States

  • Research Site

    RECRUITING

    Miami, Florida, 33122, United States

  • Research Site

    RECRUITING

    Port Orange, Florida, 32127, United States

  • Research Site

    RECRUITING

    Kansas City, Missouri, 64131, United States

  • Research Site

    RECRUITING

    St Louis, Missouri, 63123, United States

  • Research Site

    RECRUITING

    Las Vegas, Nevada, 89106, United States

  • Research Site

    RECRUITING

    Morehead City, North Carolina, 28557, United States

  • Research Site

    RECRUITING

    Raleigh, North Carolina, 27607, United States

  • Research Site

    RECRUITING

    Westlake, Ohio, 44145, United States

  • Research Site

    RECRUITING

    Yukon, Oklahoma, 73099, United States

  • Research Site

    RECRUITING

    Clarksville, Tennessee, 37040, United States

  • Research Site

    RECRUITING

    Austin, Texas, 78757, United States

  • Research Site

    RECRUITING

    Denison, Texas, 75020, United States

  • Research Site

    RECRUITING

    Georgetown, Texas, 78626, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77004, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77079, United States

  • Research Site

    RECRUITING

    San Antonio, Texas, 78215, United States

  • Research Site

    RECRUITING

    San Antonio, Texas, 78222, United States

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