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ACTIVE NOT RECRUITING
NCT05327127
PHASE2

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

Sponsor: Kowa Research Institute, Inc.

View on ClinicalTrials.gov

Summary

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

Official title: Study to Evaluate the Efficacy and Safety of Combination Therapy of K-877-ER and CSG452 in Participants With Noncirrhotic Nonalcoholic Steatohepatitis (NASH) With Liver Fibrosis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

228

Start Date

2022-11-14

Completion Date

2026-06-02

Last Updated

2026-03-27

Healthy Volunteers

No

Conditions

Interventions

DRUG

K-877-ER

K-877-ER tablet

DRUG

CSG452

CSG452 tablet

DRUG

Placebo

Placebo tablet

Locations (77)

Adobe Clinical Research, LLC

Tucson, Arizona, United States

Arizona Liver Health

Tucson, Arizona, United States

Arcare Center for Clinical Research

Little Rock, Arkansas, United States

Clinical Trials Research

Lincoln, California, United States

United Clinical Research Institute

Los Alamitos, California, United States

Velocity Clinical Research

Los Angeles, California, United States

Alliance Clinical Research

Poway, California, United States

Nature Coast Clinical Research, LLC

Inverness, Florida, United States

ENCORE Borland Groover Clinical Research

Jacksonville, Florida, United States

Miami Clinical Research

Miami, Florida, United States

Ocala GI Research

Ocala, Florida, United States

Sensible Healthcare Clinical Research, LLC

Ocoee, Florida, United States

Centricity Research

Columbus, Georgia, United States

Gastrointestinal Specialists of Georgia, PC

Marietta, Georgia, United States

Iowa Digestive Disease Center

Clive, Iowa, United States

Tandem Clinical Research, LLC

Marrero, Louisiana, United States

Mid-Atlantic GI Research, LLC

Greenbelt, Maryland, United States

Boston Medical Center Boston University Chobanian & Avedisian School of Medicine

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

GI Alliance Research

Flowood, Mississippi, United States

GI Associates Research, LLC

Columbia, Missouri, United States

Jefferson City Medical Group

Jefferson City, Missouri, United States

Lucas Research, Inc.

Morehead City, North Carolina, United States

DSI Research Northridge, LLC

Dayton, Ohio, United States

Penn State Health/Penn State College of Medicine

Hershey, Pennsylvania, United States

GI Alliance Research

Cedar Park, Texas, United States

GI Alliance Research

Dallas, Texas, United States

GI Alliance Research

Garland, Texas, United States

GLRI McAllen Research

Pharr, Texas, United States

Northeast Clinical Rsearch of San Antonio

San Antonio, Texas, United States

Endeavor Clinical Trials

San Antonio, Texas, United States

Impact Research Institute

Waco, Texas, United States

Digestive Health Research of Central Texas, LLC

Waco, Texas, United States

North Richmond Health Research

Richmond, Virginia, United States

GI Select Health Research

Richmond, Virginia, United States

Centricity

Suffolk, Virginia, United States

Liver Institute Northwest

Seattle, Washington, United States

Hospital Italiano de Buenos Aires

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

CINME - Centro De Investigaciones Metabolicas

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Hospital Italiano de La Plata

La Plata, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas de Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Hospital Universitario Austra

Pilar, Buenos Aires, Argentina

Hospital Provincial del Centenario

Santa Fe, Rosario, Argentina

Clínica de Endocrinologia e Metabologia Ltda

Brasília, Brasilia DF, Brazil

Hospital Alianca Rede D 'Or

Salvador, Estado de Bahia, Brazil

Hospital Universitário João de Barros Barreto

Belém, Pará, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Porto Alegre RS, Brazil

University of Calgary

Calgary, Alberta, Canada

Ecogene-21

Chicoutimi, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Fujita Health University Hospital

Toyoake, Aichi-ken, Japan

Ehime University Hospital

Tōon, Ehime, Japan

Fukui-ken Saiseikai Hospital

Fukui-shi, Fukui, Japan

Ogaki Municipal Hospital

Ōgaki, Gifu, Japan

NHO Takasaki General Medical Center

Takasaki Shi, Gumna, Japan

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

Hiroshima, Hiroshima, Japan

NHO Kure Medical Center and Chugoku Cancer Center

Kure Shi, Hiroshima, Japan

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, Japan

JCHO Hokkaido Hospital

Sapporo, Hokkaido, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

SHIN-YURIGAOKA General Hospital

Kawasaki, Kanagawa, Japan

St. Marianna University School of Medicine

Kawasaki, Kanagawa, Japan

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

Tohoku Rosai Hospital

Sendai, Miyagi, Japan

Shinshu University Hospital

Matsumoto Shi, Nagano, Japan

Nagano municipal Hospital

Nagano, Nagano, Japan

Saiseikai Niigata Hospital

Niigata, Niigata, Japan

Kawasaki Medical School General Medical Center

Okayama, Okayama-ken, Japan

Saga University Hospital

Saga, Saga-ken, Japan

Japanese Red Cross Musashino Hospital

Musashino, Tokyo, Japan

Nippon Medical School Hospital

Bunkyō City, Toyko, Japan

Oita Cardiovascular Hospital

Ōita, Japan

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Complejo Hospitalario Universitario A Coruna

A Coruña, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Hospital Universitario Puerta De Hierro

Madrid, Spain