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

NCT05327127 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: K-001-201
• Study Type: interventional
• Target: 228
• Locations: 6 countries
• Sites: 77

Brief Summary

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

Conditions

NASH

Outcome Measures

Primary Outcomes (1)

• Improvement in disease activity and no worsening of liver fibrosis (Yes/No)

  The improvement in disease activity is defined as decrease in NAFLD Activity Score (NAS) ≥2 points. The worsening of fibrosis is defined as any numerical increase in the stage.

  Baseline to Week 48

Secondary Outcomes (1)

• Number of Participants With Treatment-Related Adverse Events (AE)

  52 Weeks

Study Arms (4)

K-001

EXPERIMENTAL

K-877-ER and CSG452 Once daily (QD)

Drug: K-877-ER; Drug: CSG452

K-877-ER

EXPERIMENTAL

K-877-ER and CSG452 Placebo QD

Drug: K-877-ER; Drug: Placebo

CSG452

EXPERIMENTAL

CSG452 and K-877-ER Placebo QD

Drug: CSG452; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

K-877-ER DRUG

K-877-ER tablet

K-001; K-877-ER

CSG452 DRUG

CSG452 tablet

CSG452; K-001

Placebo DRUG

Placebo tablet

CSG452; K-877-ER; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and comply with study procedures and give written informed consent
• Age ≥18 years
• NAS ≥4 with a score of at least 1 in each component of the NAS (steatosis, lobular inflammation, and ballooning) at Visit 2 liver biopsy, or a historical liver biopsy performed 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 biopsy performed within 24 weeks of randomization

You may not qualify if:

• Participation in another clinical trial involving an investigational agent within 30 days prior to signing the Informed Consent Form (ICF) for this study
• Ongoing or recent consumption of Greater than moderate amounts of alcohol as defined in clinical study protocol
• Evidence of other forms of chronic liver disease as defined in clinical study protocol

Sponsors & Collaborators

• Kowa Research Institute, Inc.: lead

Study Sites (77)

Adobe Clinical Research, LLC

Tucson, Arizona, 85712, United States

Location

Arizona Liver Health

Tucson, Arizona, 85712, United States

Location

Arcare Center for Clinical Research

Little Rock, Arkansas, 72205, United States

Location

Clinical Trials Research

Lincoln, California, 95648, United States

Location

United Clinical Research Institute

Los Alamitos, California, 90720, United States

Location

Velocity Clinical Research

Los Angeles, California, 90057, United States

Location

Alliance Clinical Research

Poway, California, 92064, United States

Location

Nature Coast Clinical Research, LLC

Inverness, Florida, 34452, United States

Location

ENCORE Borland Groover Clinical Research

Jacksonville, Florida, 32256, United States

Location

Miami Clinical Research

Miami, Florida, 33155, United States

Location

Ocala GI Research

Ocala, Florida, 34471, United States

Location

Sensible Healthcare Clinical Research, LLC

Ocoee, Florida, 34761, United States

Location

Centricity Research

Columbus, Georgia, 31904, United States

Location

Gastrointestinal Specialists of Georgia, PC

Marietta, Georgia, 30060, United States

Location

Iowa Digestive Disease Center

Clive, Iowa, 50325, United States

Location

Tandem Clinical Research, LLC

Marrero, Louisiana, 70072, United States

Location

Mid-Atlantic GI Research, LLC

Greenbelt, Maryland, 20770, United States

Location

Boston Medical Center Boston University Chobanian & Avedisian School of Medicine

Boston, Massachusetts, 02118, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

GI Alliance Research

Flowood, Mississippi, 39232, United States

Location

GI Associates Research, LLC

Columbia, Missouri, 65201, United States

Location

Jefferson City Medical Group

Jefferson City, Missouri, 65109, United States

Location

Lucas Research, Inc.

Morehead City, North Carolina, 28557, United States

Location

DSI Research Northridge, LLC

Dayton, Ohio, 45414, United States

Location

Penn State Health/Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

GI Alliance Research

Cedar Park, Texas, 78613, United States

Location

GI Alliance Research

Dallas, Texas, 75246, United States

Location

GI Alliance Research

Garland, Texas, 75044, United States

Location

GLRI McAllen Research

Pharr, Texas, 78577, United States

Location

Northeast Clinical Rsearch of San Antonio

San Antonio, Texas, 78233, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78240, United States

Location

Impact Research Institute

Waco, Texas, 76710, United States

Location

Digestive Health Research of Central Texas, LLC

Waco, Texas, 76712, United States

Location

North Richmond Health Research

Richmond, Virginia, 23229, United States

Location

GI Select Health Research

Richmond, Virginia, 23236, United States

Location

Centricity

Suffolk, Virginia, 23435, United States

Location

Liver Institute Northwest

Seattle, Washington, 98105, United States

Location

Hospital Italiano de Buenos Aires

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1199, Argentina

Location

CINME - Centro De Investigaciones Metabolicas

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1056ABJ, Argentina

Location

Hospital Italiano de La Plata

La Plata, Buenos Aires, 1900, Argentina

Location

Instituto de Investigaciones Clinicas de Mar del Plata

Mar del Plata, Buenos Aires, B7600FZN, Argentina

Location

Hospital Universitario Austra

Pilar, Buenos Aires, B1629ODT, Argentina

Location

Hospital Provincial del Centenario

Santa Fe, Rosario, S2002KDS, Argentina

Location

Clínica de Endocrinologia e Metabologia Ltda

Brasília, Brasilia DF, 71625-009, Brazil

Location

Hospital Alianca Rede D 'Or

Salvador, Estado de Bahia, 41920-900, Brazil

Location

Hospital Universitário João de Barros Barreto

Belém, Pará, 66073-000, Brazil

Location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Porto Alegre RS, 90035-903, Brazil

Location

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

Ecogene-21

Chicoutimi, Quebec, G7H 7K9, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

Location

Fujita Health University Hospital

Toyoake, Aichi-ken, 470-1192, Japan

Location

Ehime University Hospital

Tōon, Ehime, 791-0295, Japan

Location

Fukui-ken Saiseikai Hospital

Fukui-shi, Fukui, 918-8503, Japan

Location

Ogaki Municipal Hospital

Ōgaki, Gifu, 503-8502, Japan

Location

NHO Takasaki General Medical Center

Takasaki Shi, Gumna, 370-0829, Japan

Location

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

Hiroshima, Hiroshima, 730-8619, Japan

Location

NHO Kure Medical Center and Chugoku Cancer Center

Kure Shi, Hiroshima, 737-0023, Japan

Location

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, 078-8510, Japan

Location

JCHO Hokkaido Hospital

Sapporo, Hokkaido, 062-8618, Japan

Location

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

SHIN-YURIGAOKA General Hospital

Kawasaki, Kanagawa, 215-0026, Japan

Location

St. Marianna University School of Medicine

Kawasaki, Kanagawa, 216-8511, Japan

Location

Yokohama City University Hospital

Yokohama, Kanagawa, 236-0004, Japan

Location

Tohoku Rosai Hospital

Sendai, Miyagi, 981-8563, Japan

Location

Shinshu University Hospital

Matsumoto Shi, Nagano, 390-8621, Japan

Location

Nagano municipal Hospital

Nagano, Nagano, 381-0006, Japan

Location

Saiseikai Niigata Hospital

Niigata, Niigata, 950-1104, Japan

Location

Kawasaki Medical School General Medical Center

Okayama, Okayama-ken, 700-8505, Japan

Location

Saga University Hospital

Saga, Saga-ken, 849-8501, Japan

Location

Japanese Red Cross Musashino Hospital

Musashino, Tokyo, 180-8610, Japan

Location

Nippon Medical School Hospital

Bunkyō City, Toyko, 113-8603, Japan

Location

Oita Cardiovascular Hospital

Ōita, 870-0837, Japan

Location

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Complejo Hospitalario Universitario A Coruna

A Coruña, 15001, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Universitario Puerta De Hierro

Madrid, 28222, Spain

Location

MeSH Terms

Interventions

6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol

Study Officials

• Shona Pendse, MD, MMSc

  Kowa Research Institute, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: April 14, 2022
• Study Start: November 14, 2022
• Primary Completion: May 5, 2026
• Study Completion (Estimated): June 2, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

JP (23); CA (3); BR (4); ES (4); US (37); AR (6)