Recruiting
Phase 2

Gene Silencing

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT05519475

Conditions

Metabolic Dysfunction-Associated SteatoHepatitis (MASH)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ALN-HSD

Placebo

Study Details

Brief summary:

This study is researching an investigational drug, ALN-HSD called "study drug". This study is focused on participants who are known to have Metabolic dysfunction-Associated SteatoHepatitis (MASH). MASH is a form of Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD). MASH occurs when fat builds up in liver cells, damaging them, and making the liver inflamed and stiff from fibrosis (scar tissue). MASH can progress to cirrhosis (long term scarring) and liver failure (when the liver cannot perform its job). The aim of the study is to see the effect of the study drug on lessening liver scarring related to MASH.

The study is looking at several other research questions, including:

  • How ALN-HSD works to improve liver function and lessen MASH-related inflammation in the liver
  • What side effects may happen from receiving the study drug
  • How much study drug and study drug metabolites (byproduct of the body breaking down the study drug) are in the blood at different times
  • Better understanding of the study drug and MASH

Conditions

Metabolic Dysfunction-Associated SteatoHepatitis (MASH)

Study ID

NCT05519475

Start date

Feb 9, 2023

Status verified date

Jul, 2026

Completion date

Dec 7, 2028

Anticipated

Primary completion date

Apr 27, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ALN-HSD

Randomized 1:1

placebo comparator: Placebo

Randomized 1:1

Interventions

ALN-HSD

Administered per the protocol

Placebo

Administered per the protocol

Primary outcome measure

  • Change in quantitative liver Fibrosis (qFibrosis) [ Time Frame: Baseline to week 52 ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Arizona Liver Health

Recruiting

Chandler, Arizona, United States, 85224

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

Recruiting

Peoria, Arizona, United States, 85381

Adobe Clinical Research

Recruiting

Tucson, Arizona, United States, 85712

Arizona Liver Health - Tucson

Recruiting

Tucson, Arizona, United States, 85712

Del Sol Research Management, LLC

Recruiting

Tucson, Arizona, United States, 85715

Southern California Research Center

Recruiting

Coronado, California, United States, 92118

Ark Clinical Research - Fountain Valley

Recruiting

Fountain Valley, California, United States, 92708

Om Research Llc

Recruiting

Lancaster, California, United States, 93534

Ark Clinical Research - Long Beach

Recruiting

Long Beach, California, United States, 90815

Clinnova Research Solutions

Recruiting

Orange, California, United States, 92868

Knowledge Research Center, St. Joseph's Medical Tower

Recruiting

Orange, California, United States, 92868

California Liver Research Institute

Recruiting

Pasadena, California, United States, 91105

Inland Empire Liver Foundation

Recruiting

Rialto, California, United States, 92377

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Evolution Clinical Trials

Recruiting

Hialeah Gardens, Florida, United States, 33016

Health Awareness, inc.

Recruiting

Jupiter, Florida, United States, 33458

Genoma Research Group, Inc.

Recruiting

Miami, Florida, United States, 33173

Med Research of Florida, LLC

Recruiting

Miami, Florida, United States, 33186

Charter Research LLC - Orlando

Recruiting

Orlando, Florida, United States, 32803

Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Tandem Clinical Research

Recruiting

Metairie, Louisiana, United States, 70006

GI Associates

Recruiting

Flowood, Mississippi, United States, 39232

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17822

Penn State Health Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

University of Pennsylvania - Perelman Center for Advanced Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

American Research Corporation

Recruiting

Austin, Texas, United States, 78757

Pinnacle Clinical Research - Austin

Recruiting

Austin, Texas, United States, 78757

Methodist Dallas Medical Center

Recruiting

Dallas, Texas, United States, 75203

GI Alliance Research

Recruiting

Fort Worth, Texas, United States, 76104

Advanced Medical Trials

Recruiting

Georgetown, Texas, United States, 78628

Pioneer Research Solutions, Inc.

Recruiting

Houston, Texas, United States, 77099

American Research Corporation at The Texas Liver Institute

Recruiting

San Antonio, Texas, United States, 78215

Pinnacle Clinical Research - San Antonio

Recruiting

San Antonio, Texas, United States, 78229

University of Virginia Medical Center

Recruiting

Charlottesville, Virginia, United States, 22903

Richmond Veterans Administration Medical Center

Recruiting

Richmond, Virginia, United States, 23249

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD)
  • Histologically confirmed MASH
  • Genetic risk alleles for MASH at the HSD17B13 locus
  • Non-Alcoholic SteatoHepatitis (NASH)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-07-08.