Phase
Condition
Hepatic Fibrosis
Hyponatremia
Treatment
K-877-ER
Placebo
CSG452
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Able to understand and comply with study procedures and give written informedconsent
Age ≥18 years
NAS ≥4 with a score of at least 1 in each component of the NAS (steatosis, lobularinflammation, and ballooning) at Visit 2 liver biopsy, or a historical liver biopsyperformed within 24 weeks of randomization
Fibrosis stage of 1 or greater and below 4 on NASH CRN (Clinical Research Network)fibrosis staging system at Visit 2 liver biopsy, or a historical liver biopsyperformed within 24 weeks of randomization
Meet all inclusion criteria outlined in clinical study protocol
Exclusion
Exclusion Criteria:
Participation in another clinical trial involving an investigational agent within 30days prior to signing the Informed Consent Form (ICF) for this study
Ongoing or recent consumption of Greater than moderate amounts of alcohol as definedin clinical study protocol
Evidence of other forms of chronic liver disease as defined in clinical studyprotocol
Does not meet any other exclusion criteria outlined in clinical study protocol
Study Design
Connect with a study center
CINME - Centro De Investigaciones Metabolicas
Ciudad Autónoma de Buenos Aires, Buenos Aires C1056ABJ
ArgentinaActive - Recruiting
CIPREC
Ciudad Autónoma de Buenos Aires, Buenos Aires 1119
ArgentinaSite Not Available
Glenny Corp. S.A.
Ciudad Autónoma de Buenos Aires, Buenos Aires C1430CKE
ArgentinaSite Not Available
Hospital Britanico de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires C1280AEB
ArgentinaSite Not Available
Hospital Italiano de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires 1199
ArgentinaActive - Recruiting
Hospital Italiano de La Plata
La Plata, Buenos Aires 1900
ArgentinaCompleted
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, Buenos Aires B7600FYK
ArgentinaSite Not Available
Instituto de Investigaciones Clinicas de Mar del Plata
Mar del Plata, Buenos Aires B7600FZN
ArgentinaSite Not Available
Hospital Universitario Austra
Pilar, Buenos Aires B1629ODT
ArgentinaSite Not Available
Hospital Provincial del Centenario
Santa Fe, Rosario S2002KDS
ArgentinaSite Not Available
Hospital Britanico de Buenos Aires
Buenos Aires,
ArgentinaSite Not Available
Hospital Italiano de Buenos Aires
Buenos Aires,
ArgentinaActive - Recruiting
CINME
Caba,
ArgentinaSite Not Available
CIPREC
City of Buenos Aires,
ArgentinaSite Not Available
Glenny Corp S A
Ciudad de Buenos Aires,
ArgentinaSite Not Available
Centro de Investigacines Medicas Mar del Plata
Mar del Plata,
ArgentinaActive - Recruiting
Instituto de Investigaciones Clinicas Mardel Plata
Mar del Plata,
ArgentinaActive - Recruiting
Hospital Universitario Austral
Pilar,
ArgentinaActive - Recruiting
Hospital Alianca Rede D 'Or
Salvador, Bahia 41920-900
BrazilSite Not Available
Clínica de Endocrinologia e Metabologia Ltda
Brasília, Brasilia DF 71625-009
BrazilSite Not Available
Hospital Universitário João de Barros Barreto
Belem, Para 66073-000
BrazilActive - Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Porto Alegre RS 90035-903
BrazilCompleted
Hospital das Clinicas FMRP-USP
Ribeirao Preto, Sao Paulo 14048-900
BrazilSite Not Available
CPCLIN - Centro de Pesquisas Clínicas Ltda.
São Paulo, Sao Paulo SP 01228-200
BrazilSite Not Available
Hospital Universitario Joao de Barros Barreto
Belem,
BrazilActive - Recruiting
Clinica de Endocrinologia e Metabologia Ltda
Brasília,
BrazilActive - Recruiting
Hospital das Clinicas FM de Ribeirao Preto USP
Ribeirao Preto,
BrazilActive - Recruiting
Hospital Alianca Rede D Or
Salvador,
BrazilActive - Recruiting
CPClin Centro de Pesquisas Clinicas
São Paulo,
BrazilSite Not Available
Acibadem City Clinic Toku da University Hospital
Sofia, Nikola 1407
BulgariaActive - Recruiting
Acibadem City Clinic Cancer Center
Sofia, Sofia City 1784
BulgariaSite Not Available
Acibadem City Clinic Tokuda Hospital Ead
Sofia, Sofia City 1407
BulgariaSite Not Available
Diagnostic - Advisory Centre Alexandrovska Ltd.
Sofia, Sofia City 1431
BulgariaSite Not Available
Acibadem City Clinic Tokuda University Hospital
Sofia,
BulgariaActive - Recruiting
DCC Alexandrovska
Sofia,
BulgariaActive - Recruiting
University of Calgary
Calgary, Alberta T2N 4Z6
CanadaSite Not Available
Ecogene-21
Chicoutimi, Quebec G7H 7K9
CanadaSite Not Available
McGill University Health Centre
Montreal, Quebec H4A 3J1
CanadaSite Not Available
Diex Recherche Quebec Inc.
Quebec City, Quebec G1V 4T3
CanadaSite Not Available
Diex Recherche Quebec Inc.
Quebec,
CanadaSite Not Available
Nagoya Clinical Trial Site
Nagoya, Aichi
JapanActive - Recruiting
Nagoya University Hospital
Nagoya, Aichi 466-8560
JapanSite Not Available
Fujita Health University Hospital
Toyoake, Aichi 470-1192
JapanSite Not Available
Toyoake Clinical Trial Site
Toyoake, Aichi
JapanActive - Recruiting
Ehime University Hospital
Toon, Ehime 791-0295
JapanActive - Recruiting
Fukui-ken Saiseikai Hospital
Fukui City, Fukui 918-8503
JapanSite Not Available
Kurume University Hospital
Kurume, Fukuoka 830-0011
JapanSite Not Available
Ogaki Municipal Hospital
Ogaki City, Gifu 503-8502
JapanSite Not Available
NHO Takasaki General Medical Center
Takasaki Shi, Gumna 370-0829
JapanSite Not Available
Takasaki Clinical Trial Site
Takasaki, Gunma
JapanSite Not Available
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima City, Hiroshima 730-8619
JapanSite Not Available
Kure Clinical Trial Site
Kure, Hiroshima
JapanSite Not Available
NHO Kure Medical Center and Chugoku Cancer Center
Kure Shi, Hiroshima 737-0023
JapanSite Not Available
Asahikawa Medical University Hospital
Asahikawa, Hokkaido 078-8510
JapanSite Not Available
Sapporo Clinical Trial Site
Sapporo, Hokkaido
JapanSite Not Available
Hokkaido University Hospital
Sapporo City, Hokkaido 060-8648
JapanSite Not Available
JCHO Hokkaido Hospital
Sapporo City, Hokkaido 062-8618
JapanCompleted
Kanazawa Clinical Trial Site
Kanazawa, Ishikawa
JapanActive - Recruiting
Kanazawa University Hospital
Kanazawa, Ishikawa 920-8641
JapanSite Not Available
Kawasaki Clinical Trial Site
Kawasaki, Kanagawa
JapanActive - Recruiting
SHIN-YURIGAOKA General Hospital
Kawasaki, Kanagawa 215-0026
JapanSite Not Available
St. Marianna University School of Medicine
Kawasaki, Kanagawa 216-8511
JapanSite Not Available
Yokohama City University Hospital
Yokohama, Kanagawa 236-0004
JapanSite Not Available
Sendai Clinical Trial Site
Sendai, Miyagi
JapanSite Not Available
Tohoku Rosai Hospital
Sendai City, Miyagi 981-8563
JapanSite Not Available
Shinshu University Hospital
Matsumoto Shi, Nagano 390-8621
JapanSite Not Available
Nagano municipal Hospital
Nagano Shi, Nagano 381-0006
JapanSite Not Available
Niigata University Medical and Dental Hospital
Niigata City, Niigata 951-8520
JapanSite Not Available
Saiseikai Niigata Hospital
Niigata City, Niigata 950-1104
JapanSite Not Available
Kawasaki Medical School General Medical Center
Okayama City, Okayama 700-8505
JapanSite Not Available
Saga University Hospital
Saga City, Saga 849-8501
JapanCompleted
Japanese Red Cross Musashino Hospital
Musashino City, Tokyo 180-8610
JapanSite Not Available
Nippon Medical School Hospital
Bunkyo ku, Toyko 113-8603
JapanSite Not Available
Asahikawa Medical University
Asahikawa City,
JapanSite Not Available
Fukui-ken Saiseikai Hospital
Fukui,
JapanSite Not Available
Fukui ken Saiseikai Hospital
Fukui City,
JapanActive - Recruiting
Hiroshima Clinical Trial Site
Hiroshima,
JapanSite Not Available
SHIN YURIGAOKA General Hospital
Kawasaki,
JapanActive - Recruiting
Shinshu University Hospital
Matsumoto,
JapanSite Not Available
Japanese Red Cross Musashino Hospital
Musashino,
JapanSite Not Available
Nagano Clinical Trial Site
Nagano,
JapanSite Not Available
Nagano Japan
Nagano,
JapanSite Not Available
Nagano municipal Hospital
Nagano,
JapanActive - Recruiting
Niigata Clinical Trial Site
Niigata,
JapanSite Not Available
Saiseikai Niigata Hospital
Niigata,
JapanSite Not Available
Oita Cardiovascular Hospital
Oita, 870-0837
JapanActive - Recruiting
Oita Clinical Trial Site
Oita,
JapanActive - Recruiting
Kawasaki Medical School General Medical Center
Okayama,
JapanSite Not Available
Saga University Hospital
Saga,
JapanSite Not Available
Saga University Hospital
Saga city,
JapanActive - Recruiting
JCHO Hokkaido Hospital
Sapporo,
JapanSite Not Available
Japan Community Health care Org Hokkaido Hospital
Sapporo city,
JapanActive - Recruiting
Nippon Medical School Hospital
Tokyo,
JapanSite Not Available
Ehime University Hospital
Tōon,
JapanSite Not Available
Ogaki Municipal Hospital
Ōgaki,
JapanSite Not Available
Hospital Universitario Marques de Valdecilla
Santander, Cantabria 39008
SpainCompleted
Complejo Hospital Miguel Servet
Zaragoza, Zargoza 50009
SpainSite Not Available
Complejo Hospitalario Universitario A Coruna
A Coruna, 15001
SpainCompleted
Hospital Abente Y Lago Complejo
Coruna,
SpainSite Not Available
Hospital General Universitario Gregorio Maranon
Madrid, 28007
SpainSite Not Available
Hospital Universitario Puerta De Hierro
Madrid, 28222
SpainSite Not Available
Hospital Clinico Universitario Virgen de la Victoria
Malaga, 29010
SpainSite Not Available
Hospital Universitario Virgen de la Victoria
Malaga,
SpainSite Not Available
Hospital Universitario Virgen Del Rocio
Sevilla,
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio
Sevilla, 41013
SpainSite Not Available
Complejo Hosp. Miguel Servet
Zaragoza,
SpainActive - Recruiting
Birmingham Digestive Health Research
Birmingham, Alabama 35209
United StatesActive - Recruiting
Birmingham Digestive Health Research, Inc.
Birmingham, Alabama 35209
United StatesSite Not Available
Birmingham Digestive Health Research, Inc.
Homewood, Alabama 35209
United StatesSite Not Available
Adobe Clinical Research, LLC
Tucson, Arizona 85712
United StatesSite Not Available
Advanced Clinical Therapeutics
Tucson, Arizona 85712
United StatesActive - Recruiting
Arizona Liver Health
Tucson, Arizona 85712
United StatesSite Not Available
ARcare Center for Clinical Reseach
Conway, Arkansas 72032
United StatesActive - Recruiting
Arcare Center for Clinical Research
Conway, Arkansas 72032
United StatesSite Not Available
Arcare Center for Clinical Research
Little Rock, Arkansas 72205
United StatesCompleted
National Research Institute
Huntington Park, California 90255
United StatesActive - Recruiting
Velocity Clinical Research
Huntington Park, California 90255
United StatesSite Not Available
UCSD NAFLD Research Center
La Jolla, California 92037
United StatesSite Not Available
Clinical Trials Research
Lincoln, California 95648
United StatesSite Not Available
United Clinical Research Institute
Los Alamitos, California 90720
United StatesCompleted
National Research Institute
Los Angeles, California 90057
United StatesActive - Recruiting
Velocity Clinical Research
Los Angeles, California 90057
United StatesCompleted
FOMAT Medical Research
Oxnard, California 93030
United StatesSite Not Available
Alliance Clinical Research
Poway, California 92064
United StatesSite Not Available
Peak Gastroenterology Associates
Colorado Springs, Colorado 80907
United StatesSite Not Available
Nature Coast Clinical Research
Inverness, Florida 34452
United StatesActive - Recruiting
Nature Coast Clinical Research, LLC
Inverness, Florida 34452
United StatesSite Not Available
ENCORE Borland Groover Clinical Research
Jacksonville, Florida 32256
United StatesCompleted
Miami Clinical Research
Miami, Florida 33155
United StatesSite Not Available
Ocala GI Research
Ocala, Florida 34471
United StatesSite Not Available
Sensible Healthcare Clinical Research
Ocoee, Florida 34761
United StatesActive - Recruiting
Sensible Healthcare Clinical Research, LLC
Ocoee, Florida 34761
United StatesSite Not Available
Sensible Healthcare LLC
Ocoee, Florida 34761
United StatesActive - Recruiting
Pensacola GI Research Center
Pensacola, Florida 32503
United StatesSite Not Available
Pensacola GI Research Center, LLC
Pensacola, Florida 32503
United StatesSite Not Available
Tampa Gen Hospital - Office of Clinical Research
Tampa, Florida 33606
United StatesSite Not Available
Tampa General Medical Group
Tampa, Florida 36606
United StatesSite Not Available
Centricity Research
Columbus, Georgia 31904
United StatesCompleted
Centricity Research Columbus Multispecialty
Columbus, Georgia 31904
United StatesActive - Recruiting
GI Specialists of GA
Marietta, Georgia 30060
United StatesActive - Recruiting
Gastrointestinal Specialists of Georgia
Marietta, Georgia 30060
United StatesActive - Recruiting
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia 30060
United StatesSite Not Available
GHP Research
New Albany, Indiana 47150
United StatesSite Not Available
Iowa Digestive Disease Center
Clive, Iowa 50325
United StatesCompleted
Tandem Clinical Research
Marrero, Louisiana 70072
United StatesActive - Recruiting
Tandem Clinical Research, LLC
Marrero, Louisiana 70072
United StatesSite Not Available
Mid-Atlantic GI Research, LLC
Greenbelt, Maryland 20770
United StatesSite Not Available
Mid-Atlantic GI Research; LLC
Greenbelt, Maryland 20770
United StatesActive - Recruiting
Boston Clinical Trial Site
Boston, Massachusetts 02118
United StatesActive - Recruiting
Boston Medical Center Boston University Chobanian & Avedisian School of Medicine
Boston, Massachusetts 02118
United StatesSite Not Available
Gastroenterology;Department of Medicine
Boston, Massachusetts 02118
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
University of Michigan Gastroenterology
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
GI Alliance - Flowood
Flowood, Mississippi 39232
United StatesActive - Recruiting
GI Alliance Research
Flowood, Mississippi 39232
United StatesSite Not Available
Southern Therapy and Advanced Research LLC
Jackson, Mississippi 39216
United StatesSite Not Available
Southern Therapy and Advanced Research, LLC
Jackson, Mississippi 39216
United StatesSite Not Available
GI Associates Research, LLC
Columbia, Missouri 65201
United StatesCompleted
GI Associates Research; LLC
Columbia, Missouri 65201
United StatesActive - Recruiting
Jefferson City Medical Group
Jefferson City, Missouri 65109
United StatesCompleted
JAVARA, Inc. / Tryon Medical Partners, PLLC
Charlotte, North Carolina 28287
United StatesActive - Recruiting
JAVARA; INC. / Tryon Medical Partners; PLLC
Charlotte, North Carolina 28287
United StatesActive - Recruiting
Javara
Charlotte, North Carolina 28287
United StatesSite Not Available
Lucas Research Inc
Morehead City, North Carolina 28557
United StatesActive - Recruiting
Lucas Research, Inc.
Morehead City, North Carolina 28557
United StatesCompleted
DSI Research Northridge
Dayton, Ohio 45414
United StatesActive - Recruiting
DSI Research Northridge, LLC
Dayton, Ohio 45414
United StatesSite Not Available
Penn State Health/ Penn State College Of Medicine
Hershey, Pennsylvania 17033
United StatesActive - Recruiting
Penn State Health/Penn State College of Medicine
Hershey, Pennsylvania 17033
United StatesSite Not Available
GI Alliance Research
Cedar Park, Texas 78613
United StatesSite Not Available
GI Alliance Research-Cedar Park
Cedar Park, Texas 78613
United StatesActive - Recruiting
GI Alliance Research
Dallas, Texas 75246
United StatesSite Not Available
GI Alliance Research - Dallas
Dallas, Texas 75246
United StatesActive - Recruiting
GI Alliance Research
Garland, Texas 75044
United StatesCompleted
GI Alliance Research - Garland
Garland, Texas 75044
United StatesActive - Recruiting
GLRI McAllen Research
Pharr, Texas 78577
United StatesSite Not Available
Diabetes & Glandular Disease Research Associates, Inc.
San Antonio, Texas 78229
United StatesSite Not Available
Diabetes and Glandular Disease Clinic, P.A.
San Antonio, Texas 78229
United StatesActive - Recruiting
Diabetes and Glandular Disease Clinic; P.A.
San Antonio, Texas 78229
United StatesActive - Recruiting
Endeavor Clinical Trials
San Antonio, Texas 78240
United StatesCompleted
Northeast Cliical Research of San Antonio, LLC
San Antonio, Texas 78233
United StatesActive - Recruiting
Northeast Clinical Research of San Antonio LLC
San Antonio, Texas 78233
United StatesActive - Recruiting
Northeast Clinical Rsearch of San Antonio
San Antonio, Texas 78233
United StatesCompleted
GI Alliance Research
San Marcos, Texas 78666
United StatesSite Not Available
GI Alliance Research - SanMarcos
San Marcos, Texas 78666
United StatesActive - Recruiting
Digestive Health Research of Central TX
Waco, Texas 76712
United StatesActive - Recruiting
Digestive Health Research of Central Texas, LLC
Waco, Texas 76712
United StatesSite Not Available
Impact Clinical Research
Waco, Texas 76710
United StatesActive - Recruiting
Impact Research Institute
Waco, Texas 76710
United StatesSite Not Available
Velocity Clinical Research
Salt Lake City, Utah 84088
United StatesSite Not Available
Velocity Research Salt Lake
West Jordan, Utah 84088
United StatesSite Not Available
Manassas Clinical Research Center
Manassas, Virginia 20110
United StatesSite Not Available
GI Select Health - Objective Health
Richmond, Virginia 23236
United StatesActive - Recruiting
GI Select Health Research
Richmond, Virginia 23236
United StatesSite Not Available
North Richmond Health Research
Richmond, Virginia 23229
United StatesSite Not Available
Centricity
Suffolk, Virginia 23435
United StatesCompleted
IACT Health VA Gastro Inst
Suffolk, Virginia 23435
United StatesActive - Recruiting
Liver Institute Northwest
Seattle, Washington 98105
United StatesCompleted
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