Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis

Last updated: May 14, 2025
Sponsor: Kowa Research Institute, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Hepatic Fibrosis

Hyponatremia

Treatment

K-877-ER

Placebo

CSG452

Clinical Study ID

NCT05327127
K-001-201
  • Ages > 18
  • All Genders

Study Summary

A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).

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

Total Participants: 200
Treatment Group(s): 3
Primary Treatment: K-877-ER
Phase: 2
Study Start date:
November 14, 2022
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • CINME - Centro De Investigaciones Metabolicas

    Ciudad Autónoma de Buenos Aires, Buenos Aires C1056ABJ
    Argentina

    Active - Recruiting

  • CIPREC

    Ciudad Autónoma de Buenos Aires, Buenos Aires 1119
    Argentina

    Site Not Available

  • Glenny Corp. S.A.

    Ciudad Autónoma de Buenos Aires, Buenos Aires C1430CKE
    Argentina

    Site Not Available

  • Hospital Britanico de Buenos Aires

    Ciudad Autónoma de Buenos Aires, Buenos Aires C1280AEB
    Argentina

    Site Not Available

  • Hospital Italiano de Buenos Aires

    Ciudad Autónoma de Buenos Aires, Buenos Aires 1199
    Argentina

    Active - Recruiting

  • Hospital Italiano de La Plata

    La Plata, Buenos Aires 1900
    Argentina

    Completed

  • Centro de Investigaciones Medicas Mar del Plata

    Mar del Plata, Buenos Aires B7600FYK
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clinicas de Mar del Plata

    Mar del Plata, Buenos Aires B7600FZN
    Argentina

    Site Not Available

  • Hospital Universitario Austra

    Pilar, Buenos Aires B1629ODT
    Argentina

    Site Not Available

  • Hospital Provincial del Centenario

    Santa Fe, Rosario S2002KDS
    Argentina

    Site Not Available

  • Hospital Britanico de Buenos Aires

    Buenos Aires,
    Argentina

    Site Not Available

  • Hospital Italiano de Buenos Aires

    Buenos Aires,
    Argentina

    Active - Recruiting

  • CINME

    Caba,
    Argentina

    Site Not Available

  • CIPREC

    City of Buenos Aires,
    Argentina

    Site Not Available

  • Glenny Corp S A

    Ciudad de Buenos Aires,
    Argentina

    Site Not Available

  • Centro de Investigacines Medicas Mar del Plata

    Mar del Plata,
    Argentina

    Active - Recruiting

  • Instituto de Investigaciones Clinicas Mardel Plata

    Mar del Plata,
    Argentina

    Active - Recruiting

  • Hospital Universitario Austral

    Pilar,
    Argentina

    Active - Recruiting

  • Hospital Alianca Rede D 'Or

    Salvador, Bahia 41920-900
    Brazil

    Site Not Available

  • Clínica de Endocrinologia e Metabologia Ltda

    Brasília, Brasilia DF 71625-009
    Brazil

    Site Not Available

  • Hospital Universitário João de Barros Barreto

    Belem, Para 66073-000
    Brazil

    Active - Recruiting

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Porto Alegre RS 90035-903
    Brazil

    Completed

  • Hospital das Clinicas FMRP-USP

    Ribeirao Preto, Sao Paulo 14048-900
    Brazil

    Site Not Available

  • CPCLIN - Centro de Pesquisas Clínicas Ltda.

    São Paulo, Sao Paulo SP 01228-200
    Brazil

    Site Not Available

  • Hospital Universitario Joao de Barros Barreto

    Belem,
    Brazil

    Active - Recruiting

  • Clinica de Endocrinologia e Metabologia Ltda

    Brasília,
    Brazil

    Active - Recruiting

  • Hospital das Clinicas FM de Ribeirao Preto USP

    Ribeirao Preto,
    Brazil

    Active - Recruiting

  • Hospital Alianca Rede D Or

    Salvador,
    Brazil

    Active - Recruiting

  • CPClin Centro de Pesquisas Clinicas

    São Paulo,
    Brazil

    Site Not Available

  • Acibadem City Clinic Toku da University Hospital

    Sofia, Nikola 1407
    Bulgaria

    Active - Recruiting

  • Acibadem City Clinic Cancer Center

    Sofia, Sofia City 1784
    Bulgaria

    Site Not Available

  • Acibadem City Clinic Tokuda Hospital Ead

    Sofia, Sofia City 1407
    Bulgaria

    Site Not Available

  • Diagnostic - Advisory Centre Alexandrovska Ltd.

    Sofia, Sofia City 1431
    Bulgaria

    Site Not Available

  • Acibadem City Clinic Tokuda University Hospital

    Sofia,
    Bulgaria

    Active - Recruiting

  • DCC Alexandrovska

    Sofia,
    Bulgaria

    Active - Recruiting

  • University of Calgary

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

  • Ecogene-21

    Chicoutimi, Quebec G7H 7K9
    Canada

    Site Not Available

  • McGill University Health Centre

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Diex Recherche Quebec Inc.

    Quebec City, Quebec G1V 4T3
    Canada

    Site Not Available

  • Diex Recherche Quebec Inc.

    Quebec,
    Canada

    Site Not Available

  • Nagoya Clinical Trial Site

    Nagoya, Aichi
    Japan

    Active - Recruiting

  • Nagoya University Hospital

    Nagoya, Aichi 466-8560
    Japan

    Site Not Available

  • Fujita Health University Hospital

    Toyoake, Aichi 470-1192
    Japan

    Site Not Available

  • Toyoake Clinical Trial Site

    Toyoake, Aichi
    Japan

    Active - Recruiting

  • Ehime University Hospital

    Toon, Ehime 791-0295
    Japan

    Active - Recruiting

  • Fukui-ken Saiseikai Hospital

    Fukui City, Fukui 918-8503
    Japan

    Site Not Available

  • Kurume University Hospital

    Kurume, Fukuoka 830-0011
    Japan

    Site Not Available

  • Ogaki Municipal Hospital

    Ogaki City, Gifu 503-8502
    Japan

    Site Not Available

  • NHO Takasaki General Medical Center

    Takasaki Shi, Gumna 370-0829
    Japan

    Site Not Available

  • Takasaki Clinical Trial Site

    Takasaki, Gunma
    Japan

    Site Not Available

  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

    Hiroshima City, Hiroshima 730-8619
    Japan

    Site Not Available

  • Kure Clinical Trial Site

    Kure, Hiroshima
    Japan

    Site Not Available

  • NHO Kure Medical Center and Chugoku Cancer Center

    Kure Shi, Hiroshima 737-0023
    Japan

    Site Not Available

  • Asahikawa Medical University Hospital

    Asahikawa, Hokkaido 078-8510
    Japan

    Site Not Available

  • Sapporo Clinical Trial Site

    Sapporo, Hokkaido
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo City, Hokkaido 060-8648
    Japan

    Site Not Available

  • JCHO Hokkaido Hospital

    Sapporo City, Hokkaido 062-8618
    Japan

    Completed

  • Kanazawa Clinical Trial Site

    Kanazawa, Ishikawa
    Japan

    Active - Recruiting

  • Kanazawa University Hospital

    Kanazawa, Ishikawa 920-8641
    Japan

    Site Not Available

  • Kawasaki Clinical Trial Site

    Kawasaki, Kanagawa
    Japan

    Active - Recruiting

  • SHIN-YURIGAOKA General Hospital

    Kawasaki, Kanagawa 215-0026
    Japan

    Site Not Available

  • St. Marianna University School of Medicine

    Kawasaki, Kanagawa 216-8511
    Japan

    Site Not Available

  • Yokohama City University Hospital

    Yokohama, Kanagawa 236-0004
    Japan

    Site Not Available

  • Sendai Clinical Trial Site

    Sendai, Miyagi
    Japan

    Site Not Available

  • Tohoku Rosai Hospital

    Sendai City, Miyagi 981-8563
    Japan

    Site Not Available

  • Shinshu University Hospital

    Matsumoto Shi, Nagano 390-8621
    Japan

    Site Not Available

  • Nagano municipal Hospital

    Nagano Shi, Nagano 381-0006
    Japan

    Site Not Available

  • Niigata University Medical and Dental Hospital

    Niigata City, Niigata 951-8520
    Japan

    Site Not Available

  • Saiseikai Niigata Hospital

    Niigata City, Niigata 950-1104
    Japan

    Site Not Available

  • Kawasaki Medical School General Medical Center

    Okayama City, Okayama 700-8505
    Japan

    Site Not Available

  • Saga University Hospital

    Saga City, Saga 849-8501
    Japan

    Completed

  • Japanese Red Cross Musashino Hospital

    Musashino City, Tokyo 180-8610
    Japan

    Site Not Available

  • Nippon Medical School Hospital

    Bunkyo ku, Toyko 113-8603
    Japan

    Site Not Available

  • Asahikawa Medical University

    Asahikawa City,
    Japan

    Site Not Available

  • Fukui-ken Saiseikai Hospital

    Fukui,
    Japan

    Site Not Available

  • Fukui ken Saiseikai Hospital

    Fukui City,
    Japan

    Active - Recruiting

  • Hiroshima Clinical Trial Site

    Hiroshima,
    Japan

    Site Not Available

  • SHIN YURIGAOKA General Hospital

    Kawasaki,
    Japan

    Active - Recruiting

  • Shinshu University Hospital

    Matsumoto,
    Japan

    Site Not Available

  • Japanese Red Cross Musashino Hospital

    Musashino,
    Japan

    Site Not Available

  • Nagano Clinical Trial Site

    Nagano,
    Japan

    Site Not Available

  • Nagano Japan

    Nagano,
    Japan

    Site Not Available

  • Nagano municipal Hospital

    Nagano,
    Japan

    Active - Recruiting

  • Niigata Clinical Trial Site

    Niigata,
    Japan

    Site Not Available

  • Saiseikai Niigata Hospital

    Niigata,
    Japan

    Site Not Available

  • Oita Cardiovascular Hospital

    Oita, 870-0837
    Japan

    Active - Recruiting

  • Oita Clinical Trial Site

    Oita,
    Japan

    Active - Recruiting

  • Kawasaki Medical School General Medical Center

    Okayama,
    Japan

    Site Not Available

  • Saga University Hospital

    Saga,
    Japan

    Site Not Available

  • Saga University Hospital

    Saga city,
    Japan

    Active - Recruiting

  • JCHO Hokkaido Hospital

    Sapporo,
    Japan

    Site Not Available

  • Japan Community Health care Org Hokkaido Hospital

    Sapporo city,
    Japan

    Active - Recruiting

  • Nippon Medical School Hospital

    Tokyo,
    Japan

    Site Not Available

  • Ehime University Hospital

    Tōon,
    Japan

    Site Not Available

  • Ogaki Municipal Hospital

    Ōgaki,
    Japan

    Site Not Available

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria 39008
    Spain

    Completed

  • Complejo Hospital Miguel Servet

    Zaragoza, Zargoza 50009
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario A Coruna

    A Coruna, 15001
    Spain

    Completed

  • Hospital Abente Y Lago Complejo

    Coruna,
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario Puerta De Hierro

    Madrid, 28222
    Spain

    Site Not Available

  • Hospital Clinico Universitario Virgen de la Victoria

    Malaga, 29010
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Victoria

    Malaga,
    Spain

    Site Not Available

  • Hospital Universitario Virgen Del Rocio

    Sevilla,
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Complejo Hosp. Miguel Servet

    Zaragoza,
    Spain

    Active - Recruiting

  • Birmingham Digestive Health Research

    Birmingham, Alabama 35209
    United States

    Active - Recruiting

  • Birmingham Digestive Health Research, Inc.

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Birmingham Digestive Health Research, Inc.

    Homewood, Alabama 35209
    United States

    Site Not Available

  • Adobe Clinical Research, LLC

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Advanced Clinical Therapeutics

    Tucson, Arizona 85712
    United States

    Active - Recruiting

  • Arizona Liver Health

    Tucson, Arizona 85712
    United States

    Site Not Available

  • ARcare Center for Clinical Reseach

    Conway, Arkansas 72032
    United States

    Active - Recruiting

  • Arcare Center for Clinical Research

    Conway, Arkansas 72032
    United States

    Site Not Available

  • Arcare Center for Clinical Research

    Little Rock, Arkansas 72205
    United States

    Completed

  • National Research Institute

    Huntington Park, California 90255
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Huntington Park, California 90255
    United States

    Site Not Available

  • UCSD NAFLD Research Center

    La Jolla, California 92037
    United States

    Site Not Available

  • Clinical Trials Research

    Lincoln, California 95648
    United States

    Site Not Available

  • United Clinical Research Institute

    Los Alamitos, California 90720
    United States

    Completed

  • National Research Institute

    Los Angeles, California 90057
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Los Angeles, California 90057
    United States

    Completed

  • FOMAT Medical Research

    Oxnard, California 93030
    United States

    Site Not Available

  • Alliance Clinical Research

    Poway, California 92064
    United States

    Site Not Available

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Nature Coast Clinical Research

    Inverness, Florida 34452
    United States

    Active - Recruiting

  • Nature Coast Clinical Research, LLC

    Inverness, Florida 34452
    United States

    Site Not Available

  • ENCORE Borland Groover Clinical Research

    Jacksonville, Florida 32256
    United States

    Completed

  • Miami Clinical Research

    Miami, Florida 33155
    United States

    Site Not Available

  • Ocala GI Research

    Ocala, Florida 34471
    United States

    Site Not Available

  • Sensible Healthcare Clinical Research

    Ocoee, Florida 34761
    United States

    Active - Recruiting

  • Sensible Healthcare Clinical Research, LLC

    Ocoee, Florida 34761
    United States

    Site Not Available

  • Sensible Healthcare LLC

    Ocoee, Florida 34761
    United States

    Active - Recruiting

  • Pensacola GI Research Center

    Pensacola, Florida 32503
    United States

    Site Not Available

  • Pensacola GI Research Center, LLC

    Pensacola, Florida 32503
    United States

    Site Not Available

  • Tampa Gen Hospital - Office of Clinical Research

    Tampa, Florida 33606
    United States

    Site Not Available

  • Tampa General Medical Group

    Tampa, Florida 36606
    United States

    Site Not Available

  • Centricity Research

    Columbus, Georgia 31904
    United States

    Completed

  • Centricity Research Columbus Multispecialty

    Columbus, Georgia 31904
    United States

    Active - Recruiting

  • GI Specialists of GA

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • Gastrointestinal Specialists of Georgia

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • Gastrointestinal Specialists of Georgia, PC

    Marietta, Georgia 30060
    United States

    Site Not Available

  • GHP Research

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Iowa Digestive Disease Center

    Clive, Iowa 50325
    United States

    Completed

  • Tandem Clinical Research

    Marrero, Louisiana 70072
    United States

    Active - Recruiting

  • Tandem Clinical Research, LLC

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • Mid-Atlantic GI Research, LLC

    Greenbelt, Maryland 20770
    United States

    Site Not Available

  • Mid-Atlantic GI Research; LLC

    Greenbelt, Maryland 20770
    United States

    Active - Recruiting

  • Boston Clinical Trial Site

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • Boston Medical Center Boston University Chobanian & Avedisian School of Medicine

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Gastroenterology;Department of Medicine

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan Gastroenterology

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • GI Alliance - Flowood

    Flowood, Mississippi 39232
    United States

    Active - Recruiting

  • GI Alliance Research

    Flowood, Mississippi 39232
    United States

    Site Not Available

  • Southern Therapy and Advanced Research LLC

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Southern Therapy and Advanced Research, LLC

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • GI Associates Research, LLC

    Columbia, Missouri 65201
    United States

    Completed

  • GI Associates Research; LLC

    Columbia, Missouri 65201
    United States

    Active - Recruiting

  • Jefferson City Medical Group

    Jefferson City, Missouri 65109
    United States

    Completed

  • JAVARA, Inc. / Tryon Medical Partners, PLLC

    Charlotte, North Carolina 28287
    United States

    Active - Recruiting

  • JAVARA; INC. / Tryon Medical Partners; PLLC

    Charlotte, North Carolina 28287
    United States

    Active - Recruiting

  • Javara

    Charlotte, North Carolina 28287
    United States

    Site Not Available

  • Lucas Research Inc

    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

  • Lucas Research, Inc.

    Morehead City, North Carolina 28557
    United States

    Completed

  • DSI Research Northridge

    Dayton, Ohio 45414
    United States

    Active - Recruiting

  • DSI Research Northridge, LLC

    Dayton, Ohio 45414
    United States

    Site Not Available

  • Penn State Health/ Penn State College Of Medicine

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Penn State Health/Penn State College of Medicine

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • GI Alliance Research

    Cedar Park, Texas 78613
    United States

    Site Not Available

  • GI Alliance Research-Cedar Park

    Cedar Park, Texas 78613
    United States

    Active - Recruiting

  • GI Alliance Research

    Dallas, Texas 75246
    United States

    Site Not Available

  • GI Alliance Research - Dallas

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • GI Alliance Research

    Garland, Texas 75044
    United States

    Completed

  • GI Alliance Research - Garland

    Garland, Texas 75044
    United States

    Active - Recruiting

  • GLRI McAllen Research

    Pharr, Texas 78577
    United States

    Site Not Available

  • Diabetes & Glandular Disease Research Associates, Inc.

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Diabetes and Glandular Disease Clinic, P.A.

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Diabetes and Glandular Disease Clinic; P.A.

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Endeavor Clinical Trials

    San Antonio, Texas 78240
    United States

    Completed

  • Northeast Cliical Research of San Antonio, LLC

    San Antonio, Texas 78233
    United States

    Active - Recruiting

  • Northeast Clinical Research of San Antonio LLC

    San Antonio, Texas 78233
    United States

    Active - Recruiting

  • Northeast Clinical Rsearch of San Antonio

    San Antonio, Texas 78233
    United States

    Completed

  • GI Alliance Research

    San Marcos, Texas 78666
    United States

    Site Not Available

  • GI Alliance Research - SanMarcos

    San Marcos, Texas 78666
    United States

    Active - Recruiting

  • Digestive Health Research of Central TX

    Waco, Texas 76712
    United States

    Active - Recruiting

  • Digestive Health Research of Central Texas, LLC

    Waco, Texas 76712
    United States

    Site Not Available

  • Impact Clinical Research

    Waco, Texas 76710
    United States

    Active - Recruiting

  • Impact Research Institute

    Waco, Texas 76710
    United States

    Site Not Available

  • Velocity Clinical Research

    Salt Lake City, Utah 84088
    United States

    Site Not Available

  • Velocity Research Salt Lake

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Site Not Available

  • GI Select Health - Objective Health

    Richmond, Virginia 23236
    United States

    Active - Recruiting

  • GI Select Health Research

    Richmond, Virginia 23236
    United States

    Site Not Available

  • North Richmond Health Research

    Richmond, Virginia 23229
    United States

    Site Not Available

  • Centricity

    Suffolk, Virginia 23435
    United States

    Completed

  • IACT Health VA Gastro Inst

    Suffolk, Virginia 23435
    United States

    Active - Recruiting

  • Liver Institute Northwest

    Seattle, Washington 98105
    United States

    Completed

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