Phase
Condition
Hepatic Fibrosis
Hyponatremia
Treatment
CSG452
K-877-ER
Placebo
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
Hospital Britanico de Buenos Aires
Buenos Aires,
ArgentinaActive - Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires,
ArgentinaActive - Recruiting
CINME
Caba,
ArgentinaActive - Recruiting
CIPREC
City of Buenos Aires,
ArgentinaActive - Recruiting
Glenny Corp S A
Ciudad de Buenos Aires,
ArgentinaActive - Recruiting
Hospital Italiano de La Plata
La Plata,
ArgentinaActive - Recruiting
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 Provincial del Centenario
Santa Fe,
ArgentinaActive - Recruiting
Hospital Universitario Joao de Barros Barreto
Belem,
BrazilActive - Recruiting
Clinica de Endocrinologia e Metabologia Ltda
Brasília,
BrazilActive - Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre,
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,
BulgariaActive - Recruiting
Acibadem City Clinic Tokuda University Hospital
Sofia,
BulgariaActive - Recruiting
DCC Alexandrovska
Sofia,
BulgariaActive - Recruiting
Diex Recherche Quebec Inc.
Quebec City, Quebec G1V 4T3
CanadaSite Not Available
University of Calgary
Calgary,
CanadaActive - Recruiting
Ecogene-21
Chicoutimi,
CanadaActive - Recruiting
McGill University Health Centre
Montreal,
CanadaActive - Recruiting
Diex Recherche Quebec Inc.
Quebec,
CanadaSite Not Available
Nagoya Clinical Trial Site
Nagoya, Aichi
JapanActive - Recruiting
Toyoake Clinical Trial Site
Toyoake, Aichi
JapanActive - Recruiting
Takasaki Clinical Trial Site
Takasaki, Gunma
JapanActive - Recruiting
Kure Clinical Trial Site
Kure, Hiroshima
JapanActive - Recruiting
Sapporo Clinical Trial Site
Sapporo, Hokkaido
JapanActive - Recruiting
Kanazawa Clinical Trial Site
Kanazawa, Ishikawa
JapanActive - Recruiting
Kawasaki Clinical Trial Site
Kawasaki, Kanagawa
JapanActive - Recruiting
Sendai Clinical Trial Site
Sendai, Miyagi
JapanActive - Recruiting
Asahikawa Medical University Hospital
Asahikawa,
JapanSite Not Available
Asahikawa Medical University
Asahikawa City,
JapanActive - Recruiting
Nippon Medical School Hospital
Bunkyo ku,
JapanActive - Recruiting
Fukui-ken Saiseikai Hospital
Fukui,
JapanSite Not Available
Fukui ken Saiseikai Hospital
Fukui City,
JapanActive - Recruiting
Hiroshima Clinical Trial Site
Hiroshima,
JapanActive - Recruiting
SHIN YURIGAOKA General Hospital
Kawasaki,
JapanActive - Recruiting
SHIN-YURIGAOKA General Hospital
Kawasaki,
JapanActive - Recruiting
Kurume University Hospital
Kurume,
JapanActive - Recruiting
Shinshu University Hospital
Matsumoto,
JapanActive - Recruiting
Japanese Red Cross Musashino Hospital
Musashino,
JapanSite Not Available
Japanese Red Cross Musashino Hospital
Musashino City,
JapanActive - Recruiting
Nagano Clinical Trial Site
Nagano,
JapanActive - Recruiting
Nagano Japan
Nagano,
JapanSite Not Available
Nagano municipal Hospital
Nagano,
JapanActive - Recruiting
Niigata Clinical Trial Site
Niigata,
JapanActive - Recruiting
Saiseikai Niigata Hospital
Niigata,
JapanSite Not Available
Saiseikai Niigata Hospital
Niigata City,
JapanActive - Recruiting
Ogaki Municipal Hospital
Ogaki City,
JapanActive - Recruiting
Oita Clinical Trial Site
Oita,
JapanActive - Recruiting
Kawasaki Medical School General Medical Center
Okayama,
JapanSite Not Available
Kawasaki Medical School General Medical Center
Okayama City,
JapanActive - Recruiting
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
Toon,
JapanActive - Recruiting
Ehime University Hospital
Tōon,
JapanSite Not Available
Yokohama City University Hospital
Yokohama,
JapanActive - Recruiting
Ogaki Municipal Hospital
Ōgaki,
JapanSite Not Available
Hospital Abente Y Lago Complejo
Coruna,
SpainActive - Recruiting
Hospital General Universitario Gregorio Maranon
Madrid,
SpainActive - Recruiting
Hospital Universitario Puerta De Hierro
Madrid,
SpainActive - Recruiting
Hospital Universitario Virgen de la Victoria
Malaga,
SpainSite Not Available
Hospital Universitario Marques de Valdecilla
Santander,
SpainActive - Recruiting
Hospital Universitario Virgen Del Rocio
Sevilla,
SpainActive - Recruiting
Complejo Hosp. Miguel Servet
Zaragoza,
SpainActive - Recruiting
Birmingham Digestive Health Research
Birmingham, Alabama 35209
United StatesActive - Recruiting
Birmingham Digestive Health Research, Inc.
Homewood, Alabama 35209
United StatesSite Not Available
Advanced Clinical Therapeutics
Tucson, Arizona 85712
United StatesActive - Recruiting
Arizona Liver Health
Tucson, Arizona 85712
United StatesActive - Recruiting
ARcare Center for Clinical Reseach
Conway, Arkansas 72032
United StatesActive - Recruiting
Arcare Center for Clinical Research
Conway, Arkansas 72032
United StatesActive - Recruiting
ARcare Center for Clinical Research
Little Rock, Arkansas 72205
United StatesActive - Recruiting
Arcare Center for Clinical Research
Little Rock, Arkansas 72205
United StatesActive - Recruiting
National Research Institute
Huntington Park, California 90255
United StatesActive - Recruiting
Velocity Clinical Research
Huntington Park, California 90255
United StatesActive - Recruiting
UCSD NAFLD Research Center
La Jolla, California 92037
United StatesActive - Recruiting
Clinical Trials Research
Lincoln, California 95648
United StatesActive - Recruiting
United Clinical Research Institute
Los Alamitos, California 90720
United StatesActive - Recruiting
National Research Institute
Los Angeles, California 90057
United StatesActive - Recruiting
Velocity Clinical Research
Los Angeles, California 90057
United StatesActive - Recruiting
FOMAT Medical Research
Oxnard, California 93030
United StatesSite Not Available
Alliance Clinical Research
Poway, California 92064
United StatesActive - Recruiting
Peak Gastroenterology Associates
Colorado Springs, Colorado 80907
United StatesActive - Recruiting
Nature Coast Clinical Research
Inverness, Florida 34452
United StatesActive - Recruiting
Nature Coast Clinical Research, LLC
Inverness, Florida 34452
United StatesActive - Recruiting
ENCORE Borland Groover Clinical Research
Jacksonville, Florida 32256
United StatesActive - Recruiting
Miami Clinical Research
Miami, Florida 33155
United StatesActive - Recruiting
Ocala GI Research
Ocala, Florida 34471
United StatesActive - Recruiting
Sensible Healthcare Clinical Research
Ocoee, Florida 34761
United StatesActive - Recruiting
Sensible Healthcare LLC
Ocoee, Florida 34761
United StatesActive - Recruiting
Pensacola GI Research Center
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 StatesActive - Recruiting
Centricity Research
Columbus, Georgia 31904
United StatesActive - Recruiting
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
GHP research
New Albany, Indiana 47150
United StatesActive - Recruiting
Iowa Digestive Disease Center
Clive, Iowa 50325
United StatesActive - Recruiting
Tandem Clinical Research
Marrero, Louisiana 70072
United StatesActive - Recruiting
Mid-Atlantic GI Research; LLC
Greenbelt, Maryland 20770
United StatesActive - Recruiting
Boston Clinical Trial Site
Boston, Massachusetts 02118
United StatesActive - Recruiting
Gastroenterology;Department of Medicine
Boston, Massachusetts 02118
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
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 StatesActive - Recruiting
Southern Therapy and Advanced Research LLC
Jackson, Mississippi 39216
United StatesSite Not Available
Southern Therapy and Advanced Research, LLC
Jackson, Mississippi 39216
United StatesActive - Recruiting
GI Associates Research, LLC
Columbia, Missouri 65201
United StatesActive - Recruiting
GI Associates Research; LLC
Columbia, Missouri 65201
United StatesActive - Recruiting
Jefferson City Medical Group
Jefferson City, Missouri 65109
United StatesActive - Recruiting
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
Lucas Research Inc
Morehead City, North Carolina 28557
United StatesActive - Recruiting
Lucas Research, Inc.
Morehead City, North Carolina 28557
United StatesActive - Recruiting
DSI Research Northridge
Dayton, Ohio 45414
United StatesActive - Recruiting
DSI Research Northridge, LLC
Dayton, Ohio 45414
United StatesActive - Recruiting
Penn State Health/ Penn State College Of Medicine
Hershey, Pennsylvania 17033
United StatesActive - Recruiting
GI Alliance Research
Cedar Park, Texas 78613
United StatesActive - Recruiting
GI Alliance Research-Cedar Park
Cedar Park, Texas 78613
United StatesActive - Recruiting
GI Alliance Research
Dallas, Texas 75246
United StatesActive - Recruiting
GI Alliance Research - Dallas
Dallas, Texas 75246
United StatesActive - Recruiting
GI Alliance Research
Garland, Texas 75044
United StatesActive - Recruiting
GI Alliance Research - Garland
Garland, Texas 75044
United StatesActive - Recruiting
GLRI McAllen Research
Pharr, Texas 78577
United StatesActive - Recruiting
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 78229
United StatesActive - Recruiting
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
GI Alliance Research
San Marcos, Texas 78666
United StatesActive - Recruiting
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 StatesActive - Recruiting
Impact Clinical Research
Waco, Texas 76710
United StatesActive - Recruiting
Velocity Research Salt Lake
West Jordan, Utah 84088
United StatesActive - Recruiting
Manassas Clinical Research Center
Manassas, Virginia 20110
United StatesActive - Recruiting
GI Select Health - Objective Health
Richmond, Virginia 23236
United StatesActive - Recruiting
GI Select Health Research
Richmond, Virginia 23236
United StatesActive - Recruiting
North Richmond Health Research
Richmond, Virginia 23229
United StatesActive - Recruiting
Centricity
Suffolk, Virginia 23435
United StatesActive - Recruiting
IACT Health VA Gastro Inst
Suffolk, Virginia 23435
United StatesActive - Recruiting
Liver Institute Northwest
Seattle, Washington 98105
United StatesActive - Recruiting
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