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New Gene-Silencing drug aims to reverse liver scarring in MASH patients

NCT ID NCT05519475

Disease control Sponsor: Regeneron Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 09, 2026 · Updated 3 times

Summary

This Phase 2 trial tests a drug called ALN-HSD, which uses gene silencing to target liver scarring in people with MASH, a fatty liver disease that can lead to cirrhosis. The study enrolls 120 adults with genetic risk factors and moderate-to-severe liver fibrosis. Researchers will measure changes in liver scarring and inflammation over time.

What this could mean

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

Active substance
ALN-HSD (a gene-silencing drug)
What this could lead to
If it works, this could lead to a new treatment that reduces liver scarring and inflammation in people with MASH who have certain genetic risk factors.
What could go wrong
This is an early Phase 2 trial with only 120 participants, so results may not apply to everyone. The drug may not work or could cause side effects not yet known.

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 120 people

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

Started

Feb 2023

Expected to finish

Dec 2028

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 to 75 years

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: 1. Adult male or female ≥18 years (or country's legal age of adulthood) 2. A diagnosis of MASH with Fibrosis (F) stage 2 or 3, according to the NASH-CRN 3. NAS score ≥3, as defined in the protocol 4. Meets genotype criteria for study enrollment, as defined in the protocol 5. Has a protocol defined FibroScan®-AST (FAST) score at screening or within approximately 12 weeks of screening Key Exclusion Criteria: 1. Evidence of other forms of known chronic liver disease, as defined in the protocol 2. Known history of alcohol or other substance abuse within the last year or at any time during screening, as defined in the protocol 3. History of Type 1 diabetes 4. Bariatric surgery within approximately 5 years prior to or planned during the study period 5. Prior exposure to any investigational drug targeting HSD17B13 or patatin-like phospholipase domain containing 3 (PNPLA3) (eg, ALN-HSD, ARO-HSD, ALN-PNP, AZD2693) Note: Other protocol-defined Inclusion/Exclusion Criteria apply

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Get notified about this study

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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.

Metabolic dysfunction associated steatohepatitis (MASH)

How to take part

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

  1. The places running it

    38 sites in 2 countries. 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

  • Adobe Clinical Research

    RECRUITING

    Tucson, Arizona, 85712, United States

  • Advanced Medical Trials

    RECRUITING

    Georgetown, Texas, 78628, United States

  • Allure Health at Mt. Olympus Medical Research

    TERMINATED

    Friendswood, Texas, 77546, United States

  • American Research Corporation

    RECRUITING

    Austin, Texas, 78757, United States

  • American Research Corporation at The Texas Liver Institute

    RECRUITING

    San Antonio, Texas, 78215, United States

  • Arizona Liver Health

    RECRUITING

    Chandler, Arizona, 85224, United States

  • Arizona Liver Health - Tucson

    RECRUITING

    Tucson, Arizona, 85712, United States

  • Ark Clinical Research - Fountain Valley

    RECRUITING

    Fountain Valley, California, 92708, United States

  • Ark Clinical Research - Long Beach

    RECRUITING

    Long Beach, California, 90815, United States

  • Austin Clinical Research, LLC

    TERMINATED

    Austin, Texas, 78745, United States

  • Cadena Care Inst.

    TERMINATED

    Poway, California, 92064, United States

  • California Liver Research Institute

    RECRUITING

    Pasadena, California, 91105, United States

  • Charter Research LLC - Orlando

    RECRUITING

    Orlando, Florida, 32803, United States

  • Clinnova Research Solutions

    RECRUITING

    Orange, California, 92868, United States

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Deaconess Clinic - GI Specialty Center

    TERMINATED

    Newburgh, Indiana, 47630, United States

  • Del Sol Research Management, LLC

    RECRUITING

    Tucson, Arizona, 85715, United States

  • Evolution Clinical Trials

    RECRUITING

    Hialeah Gardens, Florida, 33016, United States

  • Fundacion de Investigacion (FDI) Clinical Research

    RECRUITING

    San Juan, 00927, Puerto Rico

  • GI Alliance Research

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • GI Associates

    RECRUITING

    Flowood, Mississippi, 39232, United States

  • Geisinger Medical Center

    RECRUITING

    Danville, Pennsylvania, 17822, United States

  • Genoma Research Group, Inc.

    RECRUITING

    Miami, Florida, 33173, United States

  • Great Lakes Research Institute

    TERMINATED

    Pharr, Texas, 78577, United States

  • Hanyang University Seoul Hospital

    TERMINATED

    Seoul, 04763, South Korea

  • Health Awareness, inc.

    RECRUITING

    Jupiter, Florida, 33458, United States

  • Indiana University School of Medicine

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Inland Empire Liver Foundation

    RECRUITING

    Rialto, California, 92377, United States

  • Intermountain Health

    TERMINATED

    Murray, Utah, 84107, United States

  • International Medical Investigational Centers (IMIC) Incorporated

    TERMINATED

    Miami, Florida, 33157, United States

  • Isis Clinical Research Center

    TERMINATED

    Guaynabo, San Juan, 00969, Puerto Rico

  • JCHO Hokkaido Hospital

    TERMINATED

    Sapporo, Hokkaido, 062-8618, Japan

  • Keimyung University Dongsan Hospital

    TERMINATED

    Daegu, 42601, South Korea

  • Klinical Investigations

    TERMINATED

    San Juan, 00909, Puerto Rico

  • Knowledge Research Center, St. Joseph's Medical Tower

    RECRUITING

    Orange, California, 92868, United States

  • Kyungpook National University Hospital

    TERMINATED

    Daegu, 41944, South Korea

  • Latin Clinical Trial Center

    TERMINATED

    San Juan, 00909, Puerto Rico

  • Med Research of Florida, LLC

    RECRUITING

    Miami, Florida, 33186, United States

  • Mercy Medical Center

    TERMINATED

    Baltimore, Maryland, 21202, United States

  • Methodist Dallas Medical Center

    RECRUITING

    Dallas, Texas, 75203, United States

  • Miami Clinical Research

    TERMINATED

    Miami, Florida, 33155, United States

  • National Research Institute

    TERMINATED

    Panorama City, California, 91402, United States

  • Om Research Llc

    RECRUITING

    Lancaster, California, 93534, United States

  • Penn State Health Milton S. Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Pinnacle Clinical Research - Austin

    RECRUITING

    Austin, Texas, 78757, United States

  • Pinnacle Clinical Research - San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Pioneer Research Solutions, Inc.

    RECRUITING

    Houston, Texas, 77099, United States

  • Precision Research Institute - San Diego

    TERMINATED

    San Diego, California, 92114, United States

  • Pusan National University Hospital

    TERMINATED

    Busan, 49241, South Korea

  • R & H Clinical Research

    TERMINATED

    Stafford, Texas, 77477, United States

  • R & H Clinical Research, Inc.

    TERMINATED

    Katy, Texas, 77494, United States

  • Richmond Veterans Administration Medical Center

    RECRUITING

    Richmond, Virginia, 23249, United States

  • San Fernando Valley Health Institute

    TERMINATED

    Canoga Park, California, 91304, United States

  • Seoul National University Bundang Hospital

    TERMINATED

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • South Texas Research Institute (STRI) - Brownsville

    TERMINATED

    Brownsville, Texas, 78520, United States

  • South Texas Research Institute (STRI) - Edinburg

    TERMINATED

    Edinburg, Texas, 78539, United States

  • Southern California Research Center

    RECRUITING

    Coronado, California, 92118, United States

  • Synergy Healthcare LLC

    TERMINATED

    Bradenton, Florida, 34209, United States

  • Tandem Clinical Research

    RECRUITING

    Metairie, Louisiana, 70006, United States

  • The Institute for Liver Health II LLC DBA Arizona Clinical Trials - Flagstaff

    TERMINATED

    Flagstaff, Arizona, 86001, United States

  • The Institute for Liver Health II LLC DBA Arizona Liver Health - Peoria

    RECRUITING

    Peoria, Arizona, 85381, United States

  • US Associates in Research, LLC

    TERMINATED

    Miami, Florida, 33175, United States

  • University of Colorado Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Pennsylvania - Perelman Center for Advanced Medicine

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Virginia Medical Center

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Velocity Clinical Research

    TERMINATED

    Chula Vista, California, 91911, United States

  • Velocity Clinical Research

    TERMINATED

    Gardena, California, 90247, United States

  • Velocity Clinical Research - Austin

    TERMINATED

    Cedar Park, Texas, 78613, United States

  • Velocity Clinical Research - Huntington Park

    TERMINATED

    Huntington Park, California, 90255, United States

  • Velocity Clinical Research - Westlake

    TERMINATED

    Los Angeles, California, 90057, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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