Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05519475

A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adult Participants at Increased Genetic Risk for This Condition

Led by Regeneron Pharmaceuticals · Updated on 2026-05-07

120

Participants Needed

71

Research Sites

304 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adult Participants at Increased Genetic Risk for This Condition

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult male or female 18 years or older (or country's legal age of adulthood)
  • Diagnosed with MASH with fibrosis stage 2 or 3 according to the NASH-CRN
  • NAS score of 3 or higher as defined in the protocol
  • Meets genotype criteria for study enrollment as defined in the protocol
  • Has a FibroScan-AST (FAST) score at screening or within approximately 12 weeks before screening
Not Eligible

You will not qualify if you...

  • Evidence of other known chronic liver diseases as defined in the protocol
  • History of alcohol or substance abuse within the past year or during screening as defined in the protocol
  • History of Type 1 diabetes
  • Bariatric surgery within approximately 5 years before or planned during the study period
  • Prior use of investigational drugs targeting HSD17B13 or PNPLA3 (such as ALN-HSD, ARO-HSD, ALN-PNP, AZD2693)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 71 locations

1

Arizona Liver Health

Chandler, Arizona, United States, 85224

Actively Recruiting

2

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

Flagstaff, Arizona, United States, 86001

Terminated

3

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

Peoria, Arizona, United States, 85381

Actively Recruiting

4

Adobe Clinical Research

Tucson, Arizona, United States, 85712

Actively Recruiting

5

Arizona Liver Health - Tucson

Tucson, Arizona, United States, 85712

Actively Recruiting

6

Del Sol Research Management, LLC

Tucson, Arizona, United States, 85715

Actively Recruiting

7

San Fernando Valley Health Institute

Canoga Park, California, United States, 91304

Terminated

8

Velocity Clinical Research

Chula Vista, California, United States, 91911

Terminated

9

Southern California Research Center

Coronado, California, United States, 92118

Actively Recruiting

10

Ark Clinical Research - Fountain Valley

Fountain Valley, California, United States, 92708

Actively Recruiting

11

Velocity Clinical Research

Gardena, California, United States, 90247

Terminated

12

Velocity Clinical Research - Huntington Park

Huntington Park, California, United States, 90255

Terminated

13

Om Research Llc

Lancaster, California, United States, 93534

Actively Recruiting

14

Ark Clinical Research - Long Beach

Long Beach, California, United States, 90815

Actively Recruiting

15

Velocity Clinical Research - Westlake

Los Angeles, California, United States, 90057

Terminated

16

Clinnova Research Solutions

Orange, California, United States, 92868

Actively Recruiting

17

Knowledge Research Center, St. Joseph's Medical Tower

Orange, California, United States, 92868

Actively Recruiting

18

National Research Institute

Panorama City, California, United States, 91402

Terminated

19

California Liver Research Institute

Pasadena, California, United States, 91105

Actively Recruiting

20

Cadena Care Inst.

Poway, California, United States, 92064

Terminated

21

Inland Empire Liver Foundation

Rialto, California, United States, 92377

Actively Recruiting

22

Precision Research Institute - San Diego

San Diego, California, United States, 92114

Terminated

23

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

24

Synergy Healthcare LLC

Bradenton, Florida, United States, 34209

Terminated

25

Evolution Clinical Trials

Hialeah Gardens, Florida, United States, 33016

Actively Recruiting

26

Health Awareness, inc.

Jupiter, Florida, United States, 33458

Actively Recruiting

27

Miami Clinical Research

Miami, Florida, United States, 33155

Terminated

28

International Medical Investigational Centers (IMIC) Incorporated

Miami, Florida, United States, 33157

Terminated

29

Genoma Research Group, Inc.

Miami, Florida, United States, 33173

Actively Recruiting

30

US Associates in Research, LLC

Miami, Florida, United States, 33175

Terminated

31

Med Research of Florida, LLC

Miami, Florida, United States, 33186

Actively Recruiting

32

Charter Research LLC - Orlando

Orlando, Florida, United States, 32803

Actively Recruiting

33

Indiana University School of Medicine

Indianapolis, Indiana, United States, 46202

Actively Recruiting

34

Deaconess Clinic - GI Specialty Center

Newburgh, Indiana, United States, 47630

Actively Recruiting

35

Tandem Clinical Research

Metairie, Louisiana, United States, 70006

Actively Recruiting

36

Mercy Medical Center

Baltimore, Maryland, United States, 21202

Terminated

37

GI Associates

Flowood, Mississippi, United States, 39232

Actively Recruiting

38

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

39

Columbia University Irving Medical Center

New York, New York, United States, 10032

Actively Recruiting

40

Geisinger Medical Center

Danville, Pennsylvania, United States, 17822

Actively Recruiting

41

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Actively Recruiting

42

University of Pennsylvania - Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

43

Austin Clinical Research, LLC

Austin, Texas, United States, 78745

Terminated

44

American Research Corporation

Austin, Texas, United States, 78757

Actively Recruiting

45

Pinnacle Clinical Research - Austin

Austin, Texas, United States, 78757

Actively Recruiting

46

South Texas Research Institute (STRI) - Brownsville

Brownsville, Texas, United States, 78520

Actively Recruiting

47

Velocity Clinical Research - Austin

Cedar Park, Texas, United States, 78613

Terminated

48

Methodist Dallas Medical Center

Dallas, Texas, United States, 75203

Actively Recruiting

49

South Texas Research Institute (STRI) - Edinburg

Edinburg, Texas, United States, 78539

Terminated

50

GI Alliance Research

Fort Worth, Texas, United States, 76104

Actively Recruiting

51

Allure Health at Mt. Olympus Medical Research

Friendswood, Texas, United States, 77546

Terminated

52

Advanced Medical Trials

Georgetown, Texas, United States, 78628

Actively Recruiting

53

Pioneer Research Solutions, Inc.

Houston, Texas, United States, 77099

Actively Recruiting

54

R & H Clinical Research, Inc.

Katy, Texas, United States, 77494

Terminated

55

Great Lakes Research Institute

Pharr, Texas, United States, 78577

Terminated

56

American Research Corporation at The Texas Liver Institute

San Antonio, Texas, United States, 78215

Actively Recruiting

57

Pinnacle Clinical Research - San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

58

R & H Clinical Research

Stafford, Texas, United States, 77477

Terminated

59

Intermountain Health

Murray, Utah, United States, 84107

Terminated

60

University of Virginia Medical Center

Charlottesville, Virginia, United States, 22903

Actively Recruiting

61

Richmond Veterans Administration Medical Center

Richmond, Virginia, United States, 23249

Actively Recruiting

62

JCHO Hokkaido Hospital

Sapporo, Hokkaido, Japan, 062-8618

Terminated

63

Isis Clinical Research Center

Guaynabo, San Juan, Puerto Rico, 00969

Terminated

64

Klinical Investigations

San Juan, Puerto Rico, 00909

Terminated

65

Latin Clinical Trial Center

San Juan, Puerto Rico, 00909

Terminated

66

Fundacion de Investigacion (FDI) Clinical Research

San Juan, Puerto Rico, 00927

Actively Recruiting

67

Seoul National University Bundang Hospital

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

Terminated

68

Pusan National University Hospital

Busan, South Korea, 49241

Terminated

69

Kyungpook National University Hospital

Daegu, South Korea, 41944

Terminated

70

Keimyung University Dongsan Hospital

Daegu, South Korea, 42601

Terminated

71

Hanyang University Seoul Hospital

Seoul, South Korea, 04763

Terminated

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Research Team

C

Clinical Trials Administrator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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