Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Study of siRNA Gene Silencing to Treat Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adults With Genetic Risk Factors
Led by Regeneron Pharmaceuticals · Updated on 2026-05-19
120
Participants Needed
71
Research Sites
32 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an investigational drug called ALN-HSD for adults with Metabolic Dysfunction-Associated SteatoHepatitis (MASH), a liver condition where fat buildup causes inflammation and scarring. The study aims to see how ALN-HSD affects liver scarring in MASH and explores how the drug works, its side effects, and how the body processes it. This is a phase 2, randomized, double-blind, placebo-controlled clinical trial focusing on participants with genetic risk factors for MASH. Participants will be randomly assigned to receive either ALN-HSD or a placebo in equal groups. The study drug and placebo are given according to the study protocol. The trial includes a treatment period lasting up to 52 weeks, with follow-up monitoring extending to 84 weeks to assess safety and side effects. During the study, participants will undergo evaluations including liver biopsies to measure changes in liver fibrosis, blood tests for liver enzymes and fibrosis biomarkers, and genetic assessments. Researchers will closely monitor side effects and the drug's behavior in the body. The main outcome is the change in quantitative liver fibrosis from baseline to week 52, with additional measures assessing liver function and disease progression. Participants' involvement may last up to 84 weeks to cover treatment and safety follow-up.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Adult male or female aged 18 years or older (or country's legal age of adulthood)
- Diagnosis of MASH with fibrosis stage 2 or 3 according to the NASH Clinical Research Network
- NAS score of 3 or higher as defined in the protocol
- Meets defined genotype criteria for study enrollment
- Has a FibroScan-AST (FAST) score at screening or within approximately 12 weeks before screening
You will not qualify if you...
- Evidence of other known chronic liver diseases as defined in the protocol
- History of alcohol or other substance abuse within the last year or during screening
- History of Type 1 diabetes
- Bariatric surgery within approximately 5 years prior to or planned during the study
- Prior exposure to investigational drugs targeting HSD17B13 or PNPLA3 (e.g., ALN-HSD, ARO-HSD, ALN-PNP, AZD2693)
- Other protocol-defined exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants receive either the gene silencing drug ALN-HSD or placebo according to the study protocol to treat MASH.
Regular visits during treatment period as per protocol
Duration - Up to 32 weeks after treatment
Participants are monitored for safety and adverse events after the treatment period ends.
Visits for safety assessments up to week 84
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
Terminated
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
Research Team
C
Clinical Trials Administrator
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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