Phase
Condition
Primary Biliary Cholangitis
Liver Disease
Treatment
ALN-HSD
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Adult male or female ≥18 years (or country's legal age of adulthood)
A diagnosis of MASH with fibrosis (F) stage 2 or 3, according to the NASH-ClinicalResearch Network (CRN)
NAS score ≥3, as defined in the protocol
Meets genotype criteria for study enrollment, as defined in the protocol
Has protocol defined FibroScan®-AST (FAST) score at screening or withinapproximately 12 weeks of screening
Exclusion
Key Exclusion Criteria:
Evidence of other forms of known chronic liver disease, as defined in the protocol
Known history of alcohol or other substance abuse within the last year or at anytime during screening, as defined in the protocol
History of Type 1 diabetes
Bariatric surgery within approximately 5 years prior to or planned during the studyperiod
Prior exposure to any investigational drug targeting HSD17B13 or patatin-likephospholipase domain containing 3 (PNPLA3) (eg, ALN-HSD, ARO-HSD, ALN-PNP, AZD2693)
Note: Other protocol-defined Inclusion/Exclusion Criteria apply
Study Design
Connect with a study center
JCHO Hokkaido Hospital
Sapporo, Hokkaido 062-8618
JapanSite Not Available
JCHO Hokkaido Hospital
Sapporo 2128295, Hokkaido 2130037 062-8618
JapanTerminated
JCHO Hokkaido Hospital
Hokkaido, Nakanoshima 1-jo, Toyohira-ku, Sapporo-shi 062 8618
JapanSite Not Available
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do 13620
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital (SNUBH)
Seongnam-si, Gyeonggi-do 13620
Korea, Republic ofActive - Recruiting
Pusan National University Hospital
Busan, 49241
Korea, Republic ofSite Not Available
Keimyung University Dongsan Hospital
Daegu, 42601
Korea, Republic ofTerminated
Keimyung University Dongsan Medical Center
Daegu, 42601
Korea, Republic ofActive - Recruiting
Kyungpook National University Hospital
Daegu, 41944
Korea, Republic ofSite Not Available
Hanyang University Seoul Hospital
Seoul, 04763
Korea, Republic ofSite Not Available
Isis Clinical Research Center
Guaynabo, San Juan 4568138 00969
Puerto RicoTerminated
FDI Clinical Research
San Juan, 00927
Puerto RicoActive - Recruiting
Fundacion de Investigacion (FDI) Clinical Research
San Juan, 00927
Puerto RicoSite Not Available
ISIS Clinical Research Center
San Juan, 00969
Puerto RicoActive - Recruiting
Klinical Investigations
San Juan, 00909
Puerto RicoSuspended
Latin Clinical Trial Center
San Juan, 00909
Puerto RicoSuspended
Fundacion de Investigacion (FDI) Clinical Research
San Juan 4568127, 00927
Puerto RicoActive - Recruiting
Klinical Investigations
San Juan 4568127, 00909
Puerto RicoTerminated
Latin Clinical Trial Center
San Juan 4568127, 00909
Puerto RicoTerminated
Seoul National University Bundang Hospital
Seongnam-si 1897000, Gyeonggi-do 1841610 13620
South KoreaTerminated
Pusan National University Hospital
Busan 1838524, 49241
South KoreaTerminated
Keimyung University Dongsan Hospital
Daegu 1835329, 42601
South KoreaTerminated
Kyungpook National University Hospital
Daegu 1835329, 41944
South KoreaTerminated
Hanyang University Seoul Hospital
Seoul 1835848, 04763
South KoreaTerminated
Arizona Liver Health
Chandler, Arizona 85224
United StatesSite Not Available
The Institute for Liver Health II LLC dba Arizona Liver Health
Chandler, Arizona 85224
United StatesSite Not Available
The Institute for Liver Health II LLC DBA Arizona Clinical Trials - Flagstaff
Flagstaff, Arizona 86001
United StatesSite Not Available
The Institute for Liver Health II LLC DBA Arizona Liver Health - Peoria
Peoria, Arizona 85381
United StatesSite Not Available
Adobe Clinical Research
Tucson, Arizona 85712
United StatesActive - Recruiting
Arizona Liver Health - Tucson
Tucson, Arizona 85712
United StatesSite Not Available
Arizona Liver Health - Tuscon
Tucson, Arizona 85712
United StatesActive - Recruiting
Del Sol Research Management, LLC
Tucson, Arizona 85715
United StatesActive - Recruiting
Arizona Liver Health
Chandler 5289282, Arizona 5551752 85224
United StatesActive - Recruiting
The Institute for Liver Health II LLC DBA Arizona Clinical Trials - Flagstaff
Flagstaff 5294810, Arizona 5551752 86001
United StatesTerminated
The Institute for Liver Health II LLC DBA Arizona Liver Health - Peoria
Peoria 5308480, Arizona 5551752 85381
United StatesActive - Recruiting
Adobe Clinical Research
Tucson 5318313, Arizona 5551752 85712
United StatesActive - Recruiting
Arizona Liver Health - Tucson
Tucson 5318313, Arizona 5551752 85712
United StatesActive - Recruiting
Del Sol Research Management, LLC
Tucson 5318313, Arizona 5551752 85715
United StatesActive - Recruiting
San Fernando Valley Health Institute
Canoga Park, California 91304
United StatesSite Not Available
Velocity Clinical Research
Chula Vista, California 91911
United StatesSite Not Available
Southern California Research Center
Coronado, California 92118
United StatesSite Not Available
Ark Clinical Research - Fountain Valley
Fountain Valley, California 92708
United StatesSite Not Available
Velocity Clinical Research
Gardena, California 90247
United StatesSite Not Available
Velocity Clinical Research - Huntington Park
Huntington Park, California 90255
United StatesSite Not Available
Om Research Llc
Lancaster, California 93534
United StatesSite Not Available
Ark Clinical Research - Long Beach
Long Beach, California 90815
United StatesSite Not Available
National Research Institute
Los Angeles, California 90057
United StatesActive - Recruiting
Velocity Clinical Research - Westlake
Los Angeles, California 90057
United StatesSite Not Available
Clinnova Research Solutions
Orange, California 92868
United StatesActive - Recruiting
Knowledge Research Center, St. Joseph's Medical Tower
Orange, California 92868
United StatesSite Not Available
National Research Institute
Panorama City, California 91402
United StatesSite Not Available
California Liver Research Institute
Pasadena, California 91105
United StatesSite Not Available
Cadena Care Inst.
Poway, California 92064
United StatesSite Not Available
Inland Empire Liver Foundation
Rialto, California 92377
United StatesSite Not Available
Precision Research Institute - San Diego
San Diego, California 92114
United StatesSite Not Available
Precision Research Institute, Llc
San Diego, California 92114
United StatesActive - Recruiting
San Fernando Valley Health Institute
Canoga Park 5333913, California 5332921 91304
United StatesTerminated
Velocity Clinical Research
Chula Vista 5336899, California 5332921 91911
United StatesTerminated
Southern California Research Center
Coronado 5339663, California 5332921 92118
United StatesActive - Recruiting
Ark Clinical Research - Fountain Valley
Fountain Valley 5350207, California 5332921 92708
United StatesActive - Recruiting
Velocity Clinical Research
Gardena 5351549, California 5332921 90247
United StatesTerminated
Velocity Clinical Research - Huntington Park
Huntington Park 5358736, California 5332921 90255
United StatesTerminated
Om Research Llc
Lancaster 5364940, California 5332921 93534
United StatesActive - Recruiting
Ark Clinical Research - Long Beach
Long Beach 5367929, California 5332921 90815
United StatesActive - Recruiting
Velocity Clinical Research - Westlake
Los Angeles 5368361, California 5332921 90057
United StatesTerminated
Clinnova Research Solutions
Orange 5379513, California 5332921 92868
United StatesActive - Recruiting
Knowledge Research Center, St. Joseph's Medical Tower
Orange 5379513, California 5332921 92868
United StatesActive - Recruiting
National Research Institute
Panorama City 5380932, California 5332921 91402
United StatesTerminated
California Liver Research Institute
Pasadena 5381396, California 5332921 91105
United StatesActive - Recruiting
Cadena Care Inst.
Poway 5384690, California 5332921 92064
United StatesTerminated
Inland Empire Liver Foundation
Rialto 5387288, California 5332921 92377
United StatesActive - Recruiting
Precision Research Institute - San Diego
San Diego 5391811, California 5332921 92114
United StatesTerminated
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United StatesSite Not Available
University of Colorado Anschutz Medical Campus
Aurora 5412347, Colorado 5417618 80045
United StatesActive - Recruiting
Synergy Healthcare, LLC
Bradenton, Florida 34208
United StatesSite Not Available
Evolution Clinical Trials
Hialeah Gardens, Florida 33016
United StatesSite Not Available
Health Awareness, inc.
Jupiter, Florida 33458
United StatesSite Not Available
Genoma Research Group, Inc.
Miami, Florida 33173
United StatesActive - Recruiting
IMIC, Inc
Miami, Florida 33157
United StatesTerminated
Med Research Of Florida, LLC
Miami, Florida 33186
United StatesActive - Recruiting
Med Research of Florida, LLC
Miami, Florida 33186
United StatesActive - Recruiting
Miami Clinical Research Center
Miami, Florida 33155
United StatesSite Not Available
US Associates in Research, LLC
Miami, Florida 33175
United StatesSuspended
Charter Research LLC - Orlando
Orlando, Florida 32803
United StatesSite Not Available
Synergy Healthcare LLC
Bradenton 4148708, Florida 4155751 34209
United StatesTerminated
Synergy Healthcare, LLC
Bradenton 4148708, Florida 4155751 34208
United StatesTerminated
Evolution Clinical Trials
Hialeah Gardens 4158482, Florida 4155751 33016
United StatesActive - Recruiting
Health Awareness, inc.
Jupiter 4160610, Florida 4155751 33458
United StatesActive - Recruiting
Genoma Research Group, Inc.
Miami 4164138, Florida 4155751 33173
United StatesActive - Recruiting
IMIC, Inc
Miami 4164138, Florida 4155751 33157
United StatesTerminated
International Medical Investigational Centers (IMIC) Incorporated
Miami 4164138, Florida 4155751 33157
United StatesTerminated
Med Research of Florida, LLC
Miami 4164138, Florida 4155751 33186
United StatesActive - Recruiting
Miami Clinical Research
Miami 4164138, Florida 4155751 33155
United StatesTerminated
Miami Clinical Research Center
Miami 4164138, Florida 4155751 33155
United StatesTerminated
US Associates in Research, LLC
Miami 4164138, Florida 4155751 33175
United StatesTerminated
Charter Research LLC - Orlando
Orlando 4167147, Florida 4155751 32803
United StatesActive - Recruiting
Indiana University School of Medicine
Indianapolis, Indiana 46202
United StatesSite Not Available
Deaconess Clinic - GI Specialty Center
Newburgh, Indiana 47630
United StatesSite Not Available
Indiana University School of Medicine
Indianapolis 4259418, Indiana 4921868 46202
United StatesActive - Recruiting
Deaconess Clinic - GI Specialty Center
Newburgh 4262171, Indiana 4921868 47630
United StatesActive - Recruiting
Legacy Clinical Solutions: Tandem Clinical Research, LLC
Marrero, Louisiana 70072
United StatesActive - Recruiting
Tandem Clinical Research
Marrero, Louisiana 70072
United StatesSite Not Available
Tandem Clinical Research
Metairie, Louisiana 70006
United StatesSite Not Available
Tandem Clinical Research
Metairie 4333177, Louisiana 4331987 70006
United StatesActive - Recruiting
Mercy Medical Center
Baltimore, Maryland 21202
United StatesSite Not Available
Mercy Medical Center, Inc
Baltimore, Maryland 21202-2102
United StatesSite Not Available
Mercy Medical Center
Baltimore 4347778, Maryland 4361885 21202
United StatesTerminated
GI Associates
Flowood, Mississippi 39232
United StatesSite Not Available
GI Associates
Flowood 4426822, Mississippi 4436296 39232
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
United StatesActive - Recruiting
Columbia University Irving Medical Center
New York, New York 10032
United StatesSite Not Available
Columbia University Irving Medical Center
New York 5128581, New York 5128638 10032
United StatesActive - Recruiting
Geisinger Medical Center
Danville, Pennsylvania 17822
United StatesSite Not Available
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesSite Not Available
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
University of Pennsylvania - Perelman School of Medicine - Gene Therapy Program
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Geisinger Medical Center
Danville 5186327, Pennsylvania 6254927 17822
United StatesActive - Recruiting
Penn State Health Milton S. Hershey Medical Center
Hershey 5193342, Pennsylvania 6254927 17033
United StatesActive - Recruiting
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesActive - Recruiting
American Research Corporation
Austin, Texas 78757
United StatesActive - Recruiting
IMA Clinical Research Austin
Austin, Texas 78745
United StatesActive - Recruiting
Pinnacle Clinical Research - Austin
Austin, Texas 78757
United StatesSite Not Available
South Texas Research Institute (STRI) - Brownsville
Brownsville, Texas 78520
United StatesSite Not Available
Velocity Clinical Research
Cedar Park, Texas 78613
United StatesActive - Recruiting
Velocity Clinical Research - Austin
Cedar Park, Texas 78613
United StatesSite Not Available
Methodist Dallas Medical Center
Dallas, Texas 75203
United StatesSite Not Available
South Texas Research Institute (STRI) - Edinburg
Edinburg, Texas 78520
United StatesSite Not Available
GI Alliance Research
Fort Worth, Texas 76104
United StatesSite Not Available
Allure Health
Friendswood, Texas 77546-5700
United StatesActive - Recruiting
Allure Health at Mt. Olympus Medical Research
Friendswood, Texas 77546
United StatesSite Not Available
Advanced Medical Trials
Georgetown, Texas 78628
United StatesSite Not Available
Pioneer Research Solutions Inc.
Houston, Texas 77099
United StatesActive - Recruiting
Pioneer Research Solutions, Inc.
Houston, Texas 77099
United StatesSite Not Available
R & H Clinical Research
Katy, Texas 77494
United StatesActive - Recruiting
R & H Clinical Research, Inc.
Katy, Texas 77494
United StatesSite Not Available
GLRI - McAllen Research
Pharr, Texas 78577
United StatesActive - Recruiting
Great Lakes Research Institute
Pharr, Texas 78577
United StatesSite Not Available
American Research Corporation at The Texas Liver Institute
San Antonio, Texas 78215
United StatesActive - Recruiting
Pinnacle Clinical Research - San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
R & H Clinical Research
Stafford, Texas 77477
United StatesSite Not Available
American Research Corporation
Austin 4671654, Texas 4736286 78757
United StatesActive - Recruiting
Austin Clinical Research, LLC
Austin 4671654, Texas 4736286 78745
United StatesTerminated
Pinnacle Clinical Research - Austin
Austin 4671654, Texas 4736286 78757
United StatesActive - Recruiting
South Texas Research Institute (STRI) - Brownsville
Brownsville 4676740, Texas 4736286 78520
United StatesActive - Recruiting
Velocity Clinical Research - Austin
Cedar Park 4679867, Texas 4736286 78613
United StatesTerminated
Methodist Dallas Medical Center
Dallas 4684888, Texas 4736286 75203
United StatesActive - Recruiting
South Texas Research Institute (STRI) - Edinburg
Edinburg 4688275, Texas 4736286 78539
United StatesActive - Recruiting
GI Alliance Research
Fort Worth 4691930, Texas 4736286 76104
United StatesActive - Recruiting
Allure Health at Mt. Olympus Medical Research
Friendswood 4692521, Texas 4736286 77546
United StatesTerminated
Advanced Medical Trials
Georgetown 4693342, Texas 4736286 78628
United StatesActive - Recruiting
Pioneer Research Solutions, Inc.
Houston 4699066, Texas 4736286 77099
United StatesActive - Recruiting
R & H Clinical Research, Inc.
Katy 4702732, Texas 4736286 77494
United StatesTerminated
Great Lakes Research Institute
Pharr 4718721, Texas 4736286 78577
United StatesTerminated
American Research Corporation at The Texas Liver Institute
San Antonio 4726206, Texas 4736286 78215
United StatesActive - Recruiting
Pinnacle Clinical Research - San Antonio
San Antonio 4726206, Texas 4736286 78229
United StatesActive - Recruiting
R & H Clinical Research
Stafford 4734005, Texas 4736286 77477
United StatesTerminated
Intermountain Health
Murray 5778755, Utah 5549030 84107
United StatesActive - Recruiting
University of Virginia Medical Center
Charlottesville, Virginia 22903
United StatesSite Not Available
Richmond Va Medical Center
Richmond, Virginia 23249
United StatesSite Not Available
University of Virginia Medical Center
Charlottesville 4752031, Virginia 6254928 22903
United StatesActive - Recruiting
Richmond Va Medical Center
Richmond 4781708, Virginia 6254928 23249
United StatesActive - Recruiting
Richmond Veterans Administration Medical Center
Richmond 4781708, Virginia 6254928 23249
United StatesActive - Recruiting

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