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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

228

Participants

Timeline

Start Date

November 14, 2022

Primary Completion Date

February 28, 2026

Study Completion Date

March 31, 2026

Conditions
NASH
Interventions
DRUG

K-877-ER

K-877-ER tablet

DRUG

CSG452

CSG452 tablet

DRUG

Placebo

Placebo tablet

Trial Locations (77)

1199

Hospital Italiano de Buenos Aires, Ciudad Autónoma de Buenos Aires

1900

Hospital Italiano de La Plata, La Plata

15001

Complejo Hospitalario Universitario A Coruna, A Coruña

17033

Penn State Health/Penn State College of Medicine, Hershey

20770

Mid-Atlantic GI Research, LLC, Greenbelt

23229

North Richmond Health Research, Richmond

23236

GI Select Health Research, Richmond

23435

Centricity, Suffolk

28007

Hospital General Universitario Gregorio Maranon, Madrid

28222

Hospital Universitario Puerta De Hierro, Madrid

28557

Lucas Research, Inc., Morehead City

30060

Gastrointestinal Specialists of Georgia, PC, Marietta

31904

Centricity Research, Columbus

32256

ENCORE Borland Groover Clinical Research, Jacksonville

33155

Miami Clinical Research, Miami

34452

Nature Coast Clinical Research, LLC, Inverness

34471

Ocala GI Research, Ocala

34761

Sensible Healthcare Clinical Research, LLC, Ocoee

39008

Hospital Universitario Marques de Valdecilla, Santander

39232

GI Alliance Research, Flowood

45414

DSI Research Northridge, LLC, Dayton

48109

University of Michigan, Ann Arbor

50325

Iowa Digestive Disease Center, Clive

65109

Jefferson City Medical Group, Jefferson City

65201

GI Associates Research, LLC, Columbia

70072

Tandem Clinical Research, LLC, Marrero

72205

Arcare Center for Clinical Research, Little Rock

75044

GI Alliance Research, Garland

75246

GI Alliance Research, Dallas

76710

Impact Research Institute, Waco

76712

Digestive Health Research of Central Texas, LLC, Waco

78233

Northeast Clinical Rsearch of San Antonio, San Antonio

78240

Endeavor Clinical Trials, San Antonio

78577

GLRI McAllen Research, Pharr

78613

GI Alliance Research, Cedar Park

85712

Adobe Clinical Research, LLC, Tucson

Arizona Liver Health, Tucson

90057

Velocity Clinical Research, Los Angeles

90720

United Clinical Research Institute, Los Alamitos

92064

Alliance Clinical Research, Poway

95648

Clinical Trials Research, Lincoln

98105

Liver Institute Northwest, Seattle

02118

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

C1056ABJ

CINME - Centro De Investigaciones Metabolicas, Ciudad Autónoma de Buenos Aires

B7600FZN

Instituto de Investigaciones Clinicas de Mar del Plata, Mar del Plata

B1629ODT

Hospital Universitario Austra, Pilar

S2002KDS

Hospital Provincial del Centenario, Santa Fe

71625-009

Clínica de Endocrinologia e Metabologia Ltda, Brasília

41920-900

Hospital Alianca Rede D 'Or, Salvador

66073-000

Hospital Universitário João de Barros Barreto, Belém

90035-903

Hospital de Clinicas de Porto Alegre, Porto Alegre

T2N 4Z6

University of Calgary, Calgary

G7H 7K9

Ecogene-21, Chicoutimi

H4A 3J1

McGill University Health Centre, Montreal

466-8560

Nagoya University Hospital, Nagoya

470-1192

Fujita Health University Hospital, Toyoake

791-0295

Ehime University Hospital, Tōon

918-8503

Fukui-ken Saiseikai Hospital, Fukui-shi

503-8502

Ogaki Municipal Hospital, Ōgaki

370-0829

NHO Takasaki General Medical Center, Takasaki Shi

730-8619

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital, Hiroshima

737-0023

NHO Kure Medical Center and Chugoku Cancer Center, Kure Shi

078-8510

Asahikawa Medical University Hospital, Asahikawa

062-8618

JCHO Hokkaido Hospital, Sapporo

920-8641

Kanazawa University Hospital, Kanazawa

215-0026

SHIN-YURIGAOKA General Hospital, Kawasaki

216-8511

St. Marianna University School of Medicine, Kawasaki

236-0004

Yokohama City University Hospital, Yokohama

981-8563

Tohoku Rosai Hospital, Sendai

390-8621

Shinshu University Hospital, Matsumoto Shi

381-0006

Nagano municipal Hospital, Nagano

950-1104

Saiseikai Niigata Hospital, Niigata

700-8505

Kawasaki Medical School General Medical Center, Okayama

849-8501

Saga University Hospital, Saga

180-8610

Japanese Red Cross Musashino Hospital, Musashino

113-8603

Nippon Medical School Hospital, Bunkyō City

870-0837

Oita Cardiovascular Hospital, Ōita

Sponsors
All Listed Sponsors
lead

Kowa Research Institute, Inc.

INDUSTRY

NCT05327127 - Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis | Biotech Hunter | Biotech Hunter