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

Last updated: October 25, 2024
Sponsor: Kowa Research Institute, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Hepatic Fibrosis

Hyponatremia

Treatment

CSG452

K-877-ER

Placebo

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: CSG452
Phase: 2
Study Start date:
November 14, 2022
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Hospital Britanico de Buenos Aires

    Buenos Aires,
    Argentina

    Active - Recruiting

  • Hospital Italiano de Buenos Aires

    Buenos Aires,
    Argentina

    Active - Recruiting

  • CINME

    Caba,
    Argentina

    Active - Recruiting

  • CIPREC

    City of Buenos Aires,
    Argentina

    Active - Recruiting

  • Glenny Corp S A

    Ciudad de Buenos Aires,
    Argentina

    Active - Recruiting

  • Hospital Italiano de La Plata

    La Plata,
    Argentina

    Active - Recruiting

  • 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 Provincial del Centenario

    Santa Fe,
    Argentina

    Active - Recruiting

  • Hospital Universitario Joao de Barros Barreto

    Belem,
    Brazil

    Active - Recruiting

  • Clinica de Endocrinologia e Metabologia Ltda

    Brasília,
    Brazil

    Active - Recruiting

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre,
    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,
    Bulgaria

    Active - Recruiting

  • Acibadem City Clinic Tokuda University Hospital

    Sofia,
    Bulgaria

    Active - Recruiting

  • DCC Alexandrovska

    Sofia,
    Bulgaria

    Active - Recruiting

  • Diex Recherche Quebec Inc.

    Quebec City, Quebec G1V 4T3
    Canada

    Site Not Available

  • University of Calgary

    Calgary,
    Canada

    Active - Recruiting

  • Ecogene-21

    Chicoutimi,
    Canada

    Active - Recruiting

  • McGill University Health Centre

    Montreal,
    Canada

    Active - Recruiting

  • Diex Recherche Quebec Inc.

    Quebec,
    Canada

    Site Not Available

  • Nagoya Clinical Trial Site

    Nagoya, Aichi
    Japan

    Active - Recruiting

  • Toyoake Clinical Trial Site

    Toyoake, Aichi
    Japan

    Active - Recruiting

  • Takasaki Clinical Trial Site

    Takasaki, Gunma
    Japan

    Active - Recruiting

  • Kure Clinical Trial Site

    Kure, Hiroshima
    Japan

    Active - Recruiting

  • Sapporo Clinical Trial Site

    Sapporo, Hokkaido
    Japan

    Active - Recruiting

  • Kanazawa Clinical Trial Site

    Kanazawa, Ishikawa
    Japan

    Active - Recruiting

  • Kawasaki Clinical Trial Site

    Kawasaki, Kanagawa
    Japan

    Active - Recruiting

  • Sendai Clinical Trial Site

    Sendai, Miyagi
    Japan

    Active - Recruiting

  • Asahikawa Medical University Hospital

    Asahikawa,
    Japan

    Site Not Available

  • Asahikawa Medical University

    Asahikawa City,
    Japan

    Active - Recruiting

  • Nippon Medical School Hospital

    Bunkyo ku,
    Japan

    Active - Recruiting

  • Fukui-ken Saiseikai Hospital

    Fukui,
    Japan

    Site Not Available

  • Fukui ken Saiseikai Hospital

    Fukui City,
    Japan

    Active - Recruiting

  • Hiroshima Clinical Trial Site

    Hiroshima,
    Japan

    Active - Recruiting

  • SHIN YURIGAOKA General Hospital

    Kawasaki,
    Japan

    Active - Recruiting

  • SHIN-YURIGAOKA General Hospital

    Kawasaki,
    Japan

    Active - Recruiting

  • Kurume University Hospital

    Kurume,
    Japan

    Active - Recruiting

  • Shinshu University Hospital

    Matsumoto,
    Japan

    Active - Recruiting

  • Japanese Red Cross Musashino Hospital

    Musashino,
    Japan

    Site Not Available

  • Japanese Red Cross Musashino Hospital

    Musashino City,
    Japan

    Active - Recruiting

  • Nagano Clinical Trial Site

    Nagano,
    Japan

    Active - Recruiting

  • Nagano Japan

    Nagano,
    Japan

    Site Not Available

  • Nagano municipal Hospital

    Nagano,
    Japan

    Active - Recruiting

  • Niigata Clinical Trial Site

    Niigata,
    Japan

    Active - Recruiting

  • Saiseikai Niigata Hospital

    Niigata,
    Japan

    Site Not Available

  • Saiseikai Niigata Hospital

    Niigata City,
    Japan

    Active - Recruiting

  • Ogaki Municipal Hospital

    Ogaki City,
    Japan

    Active - Recruiting

  • Oita Clinical Trial Site

    Oita,
    Japan

    Active - Recruiting

  • Kawasaki Medical School General Medical Center

    Okayama,
    Japan

    Site Not Available

  • Kawasaki Medical School General Medical Center

    Okayama City,
    Japan

    Active - Recruiting

  • 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

    Toon,
    Japan

    Active - Recruiting

  • Ehime University Hospital

    Tōon,
    Japan

    Site Not Available

  • Yokohama City University Hospital

    Yokohama,
    Japan

    Active - Recruiting

  • Ogaki Municipal Hospital

    Ōgaki,
    Japan

    Site Not Available

  • Hospital Abente Y Lago Complejo

    Coruna,
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta De Hierro

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Malaga,
    Spain

    Site Not Available

  • Hospital Universitario Marques de Valdecilla

    Santander,
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Del Rocio

    Sevilla,
    Spain

    Active - Recruiting

  • Complejo Hosp. Miguel Servet

    Zaragoza,
    Spain

    Active - Recruiting

  • Birmingham Digestive Health Research

    Birmingham, Alabama 35209
    United States

    Active - Recruiting

  • Birmingham Digestive Health Research, Inc.

    Homewood, Alabama 35209
    United States

    Site Not Available

  • Advanced Clinical Therapeutics

    Tucson, Arizona 85712
    United States

    Active - Recruiting

  • Arizona Liver Health

    Tucson, Arizona 85712
    United States

    Active - Recruiting

  • ARcare Center for Clinical Reseach

    Conway, Arkansas 72032
    United States

    Active - Recruiting

  • Arcare Center for Clinical Research

    Conway, Arkansas 72032
    United States

    Active - Recruiting

  • ARcare Center for Clinical Research

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • Arcare Center for Clinical Research

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • National Research Institute

    Huntington Park, California 90255
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Huntington Park, California 90255
    United States

    Active - Recruiting

  • UCSD NAFLD Research Center

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Clinical Trials Research

    Lincoln, California 95648
    United States

    Active - Recruiting

  • United Clinical Research Institute

    Los Alamitos, California 90720
    United States

    Active - Recruiting

  • National Research Institute

    Los Angeles, California 90057
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Los Angeles, California 90057
    United States

    Active - Recruiting

  • FOMAT Medical Research

    Oxnard, California 93030
    United States

    Site Not Available

  • Alliance Clinical Research

    Poway, California 92064
    United States

    Active - Recruiting

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado 80907
    United States

    Active - Recruiting

  • Nature Coast Clinical Research

    Inverness, Florida 34452
    United States

    Active - Recruiting

  • Nature Coast Clinical Research, LLC

    Inverness, Florida 34452
    United States

    Active - Recruiting

  • ENCORE Borland Groover Clinical Research

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Miami Clinical Research

    Miami, Florida 33155
    United States

    Active - Recruiting

  • Ocala GI Research

    Ocala, Florida 34471
    United States

    Active - Recruiting

  • Sensible Healthcare Clinical Research

    Ocoee, Florida 34761
    United States

    Active - Recruiting

  • Sensible Healthcare LLC

    Ocoee, Florida 34761
    United States

    Active - Recruiting

  • Pensacola GI Research Center

    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

    Active - Recruiting

  • Centricity Research

    Columbus, Georgia 31904
    United States

    Active - Recruiting

  • 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

  • GHP research

    New Albany, Indiana 47150
    United States

    Active - Recruiting

  • Iowa Digestive Disease Center

    Clive, Iowa 50325
    United States

    Active - Recruiting

  • Tandem Clinical Research

    Marrero, Louisiana 70072
    United States

    Active - Recruiting

  • Mid-Atlantic GI Research; LLC

    Greenbelt, Maryland 20770
    United States

    Active - Recruiting

  • Boston Clinical Trial Site

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • Gastroenterology;Department of Medicine

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • 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

    Active - Recruiting

  • 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

    Active - Recruiting

  • GI Associates Research, LLC

    Columbia, Missouri 65201
    United States

    Active - Recruiting

  • GI Associates Research; LLC

    Columbia, Missouri 65201
    United States

    Active - Recruiting

  • Jefferson City Medical Group

    Jefferson City, Missouri 65109
    United States

    Active - Recruiting

  • 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

  • Lucas Research Inc

    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

  • Lucas Research, Inc.

    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

  • DSI Research Northridge

    Dayton, Ohio 45414
    United States

    Active - Recruiting

  • DSI Research Northridge, LLC

    Dayton, Ohio 45414
    United States

    Active - Recruiting

  • Penn State Health/ Penn State College Of Medicine

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • GI Alliance Research

    Cedar Park, Texas 78613
    United States

    Active - Recruiting

  • GI Alliance Research-Cedar Park

    Cedar Park, Texas 78613
    United States

    Active - Recruiting

  • GI Alliance Research

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • GI Alliance Research - Dallas

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • GI Alliance Research

    Garland, Texas 75044
    United States

    Active - Recruiting

  • GI Alliance Research - Garland

    Garland, Texas 75044
    United States

    Active - Recruiting

  • GLRI McAllen Research

    Pharr, Texas 78577
    United States

    Active - Recruiting

  • 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 78229
    United States

    Active - Recruiting

  • 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

  • GI Alliance Research

    San Marcos, Texas 78666
    United States

    Active - Recruiting

  • 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

    Active - Recruiting

  • Impact Clinical Research

    Waco, Texas 76710
    United States

    Active - Recruiting

  • Velocity Research Salt Lake

    West Jordan, Utah 84088
    United States

    Active - Recruiting

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Active - Recruiting

  • GI Select Health - Objective Health

    Richmond, Virginia 23236
    United States

    Active - Recruiting

  • GI Select Health Research

    Richmond, Virginia 23236
    United States

    Active - Recruiting

  • North Richmond Health Research

    Richmond, Virginia 23229
    United States

    Active - Recruiting

  • Centricity

    Suffolk, Virginia 23435
    United States

    Active - Recruiting

  • IACT Health VA Gastro Inst

    Suffolk, Virginia 23435
    United States

    Active - Recruiting

  • Liver Institute Northwest

    Seattle, Washington 98105
    United States

    Active - Recruiting

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