Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis
- Registration Number
- NCT05327127
- Lead Sponsor
- Kowa Research Institute, Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- Meet all inclusion criteria outlined in clinical study protocol
- 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
- Does not meet any other exclusion criteria outlined in clinical study protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description K-001 K-877-ER K-877-ER and CSG452 Once daily (QD) K-001 CSG452 K-877-ER and CSG452 Once daily (QD) K-877-ER K-877-ER K-877-ER and CSG452 Placebo QD K-877-ER Placebo K-877-ER and CSG452 Placebo QD CSG452 Placebo CSG452 and K-877-ER Placebo QD Placebo Placebo - CSG452 CSG452 CSG452 and K-877-ER Placebo QD
- Primary Outcome Measures
Name Time Method Improvement in disease activity and no worsening of liver fibrosis (Yes/No) Baseline to Week 48 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment-Related Adverse Events (AE) 52 Weeks Time frame is 52 weeks unless an unresolved AE is still being followed
Trial Locations
- Locations (101)
Centricity Research
🇺🇸Columbus, Georgia, United States
Birmingham Digestive Health Research, Inc.
🇺🇸Birmingham, Alabama, United States
Adobe Clinical Research, LLC
🇺🇸Tucson, Arizona, United States
Arcare Center for Clinical Research
🇺🇸Little Rock, Arkansas, United States
Velocity Clinical Research
🇺🇸Salt Lake City, Utah, United States
FOMAT Medical Research
🇺🇸Oxnard, California, United States
Nature Coast Clinical Research, LLC
🇺🇸Inverness, Florida, United States
Sensible Healthcare Clinical Research, LLC
🇺🇸Ocoee, Florida, United States
Pensacola GI Research Center, LLC
🇺🇸Pensacola, Florida, United States
GI Alliance Research
🇺🇸San Marcos, Texas, United States
Southern Therapy and Advanced Research, LLC
🇺🇸Jackson, Mississippi, United States
GI Associates Research, LLC
🇺🇸Columbia, Missouri, United States
Javara
🇺🇸Charlotte, North Carolina, United States
Lucas Research, Inc.
🇺🇸Morehead City, North Carolina, United States
Diabetes & Glandular Disease Research Associates, Inc.
🇺🇸San Antonio, Texas, United States
Northeast Clinical Rsearch of San Antonio
🇺🇸San Antonio, Texas, United States
Impact Research Institute
🇺🇸Waco, Texas, United States
Digestive Health Research of Central Texas, LLC
🇺🇸Waco, Texas, United States
Tampa General Medical Group
🇺🇸Tampa, Florida, United States
Boston Medical Center Boston University Chobanian & Avedisian School of Medicine
🇺🇸Boston, Massachusetts, United States
Penn State Health/Penn State College of Medicine
🇺🇸Hershey, Pennsylvania, United States
GHP Research
🇺🇸New Albany, Indiana, United States
Tandem Clinical Research, LLC
🇺🇸Marrero, Louisiana, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Gastrointestinal Specialists of Georgia, PC
🇺🇸Marietta, Georgia, United States
Mid-Atlantic GI Research, LLC
🇺🇸Greenbelt, Maryland, United States
DSI Research Northridge, LLC
🇺🇸Dayton, Ohio, United States
GI Select Health Research
🇺🇸Richmond, Virginia, United States
Centricity
🇺🇸Suffolk, Virginia, United States
CINME - Centro De Investigaciones Metabolicas
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Glenny Corp. S.A.
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Centro de Investigaciones Medicas Mar del Plata
🇦🇷Mar del 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 Alianca Rede D 'Or
🇧🇷Salvador, Bahia, Brazil
Clínica de Endocrinologia e Metabologia Ltda
🇧🇷Brasília, Brasilia DF, Brazil
Hospital Universitário João de Barros Barreto
🇧🇷Belem, Para, Brazil
CPCLIN - Centro de Pesquisas Clínicas Ltda.
🇧🇷São Paulo, Sao Paulo SP, Brazil
Acibadem City Clinic Tokuda Hospital Ead
🇧🇬Sofia, Sofia City, Bulgaria
Diagnostic - Advisory Centre Alexandrovska Ltd.
🇧🇬Sofia, Sofia City, Bulgaria
Hospital das Clinicas FMRP-USP
🇧🇷Ribeirao Preto, Sao Paulo, Brazil
Fujita Health University Hospital
🇯🇵Toyoake, Aichi, Japan
Fukui-ken Saiseikai Hospital
🇯🇵Fukui City, Fukui, Japan
NHO Takasaki General Medical Center
🇯🇵Takasaki Shi, Gumna, Japan
Acibadem City Clinic Cancer Center
🇧🇬Sofia, Sofia City, Bulgaria
Diex Recherche Quebec Inc.
🇨🇦Quebec City, Quebec, Canada
Nagoya University Hospital
🇯🇵Nagoya, Aichi, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
🇯🇵Hiroshima City, Hiroshima, Japan
NHO Kure Medical Center and Chugoku Cancer Center
🇯🇵Kure Shi, Hiroshima, Japan
Asahikawa Medical University Hospital
🇯🇵Asahikawa, Hokkaido, Japan
Hokkaido University Hospital
🇯🇵Sapporo City, Hokkaido, Japan
JCHO Hokkaido Hospital
🇯🇵Sapporo City, Hokkaido, Japan
Kanazawa University Hospital
🇯🇵Kanazawa, Ishikawa, Japan
SHIN-YURIGAOKA General Hospital
🇯🇵Kawasaki, Kanagawa, Japan
St. Marianna University School of Medicine
🇯🇵Kawasaki, Kanagawa, Japan
Tohoku Rosai Hospital
🇯🇵Sendai City, Miyagi, Japan
Nagano municipal Hospital
🇯🇵Nagano Shi, Nagano, Japan
Niigata University Medical and Dental Hospital
🇯🇵Niigata City, Niigata, Japan
Oita Cardiovascular Hospital
🇯🇵Oita, Japan
Complejo Hospital Miguel Servet
🇪🇸Zaragoza, Zargoza, Spain
Complejo Hospitalario Universitario A Coruna
🇪🇸A Coruna, Spain
Hospital Clinico Universitario Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Arizona Liver Health
🇺🇸Tucson, Arizona, United States
UCSD NAFLD Research Center
🇺🇸La Jolla, California, United States
Clinical Trials Research
🇺🇸Lincoln, California, United States
United Clinical Research Institute
🇺🇸Los Alamitos, California, United States
Alliance Clinical Research
🇺🇸Poway, California, United States
Peak Gastroenterology Associates
🇺🇸Colorado Springs, Colorado, 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
Iowa Digestive Disease Center
🇺🇸Clive, Iowa, United States
Jefferson City Medical Group
🇺🇸Jefferson City, Missouri, United States
GLRI McAllen Research
🇺🇸Pharr, Texas, United States
Endeavor Clinical Trials
🇺🇸San Antonio, Texas, United States
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
North Richmond Health Research
🇺🇸Richmond, Virginia, United States
Liver Institute Northwest
🇺🇸Seattle, Washington, United States
CIPREC
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Hospital Britanico de Buenos Aires
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Hospital Italiano de La Plata
🇦🇷La Plata, Buenos Aires, Argentina
Hospital Provincial del Centenario
🇦🇷Santa Fe, Rosario, Argentina
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
Ehime University Hospital
🇯🇵Toon, Ehime, Japan
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
Ogaki Municipal Hospital
🇯🇵Ogaki City, Gifu, Japan
Yokohama City University Hospital
🇯🇵Yokohama, Kanagawa, Japan
Shinshu University Hospital
🇯🇵Matsumoto Shi, Nagano, Japan
Saiseikai Niigata Hospital
🇯🇵Niigata City, Niigata, Japan
Kawasaki Medical School General Medical Center
🇯🇵Okayama City, Okayama, Japan
Saga University Hospital
🇯🇵Saga City, Saga, Japan
Japanese Red Cross Musashino Hospital
🇯🇵Musashino City, Tokyo, Japan
Nippon Medical School Hospital
🇯🇵Bunkyo ku, Toyko, Japan
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Universitario Puerta De Hierro
🇪🇸Madrid, Spain