Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis
NCT ID: NCT05327127
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
228 participants
INTERVENTIONAL
2022-11-14
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Safety and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH)
NCT02855164
Safety, Tolerability, Pharmacokinetics and Activity of GS-9450 in Adults With Non-Alcoholic Steatohepatitis (NASH)
NCT00740610
A Study to Evaluate the Efficacy and Safety of JKB-122 in Patients With NASH and Fibrosis
NCT04255069
A Study of the Efficacy and Safety of CF102 in the Treatment of Non-Alcoholic Fatty Liver Disease
NCT02927314
Study of SGM-1019 in Patients With Nonalcoholic Steatohepatitis (NASH)
NCT03676231
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
K-001
K-877-ER and CSG452 Once daily (QD)
K-877-ER
K-877-ER tablet
CSG452
CSG452 tablet
K-877-ER
K-877-ER and CSG452 Placebo QD
K-877-ER
K-877-ER tablet
Placebo
Placebo tablet
CSG452
CSG452 and K-877-ER Placebo QD
CSG452
CSG452 tablet
Placebo
Placebo tablet
Placebo
Placebo
Placebo tablet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
K-877-ER
K-877-ER tablet
CSG452
CSG452 tablet
Placebo
Placebo tablet
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kowa Research Institute, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shona Pendse, MD, MMSc
Role: STUDY_CHAIR
Kowa Research Institute, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
K-001-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.