Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis
Launched by KOWA RESEARCH INSTITUTE, INC. · Apr 6, 2022
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new treatment for adults with Nonalcoholic Steatohepatitis (NASH), a liver condition that can lead to serious health issues. The study aims to evaluate the effectiveness and safety of a combination therapy using two investigational drugs, K-877-ER and CSG452. Researchers are currently recruiting participants who are at least 18 years old and have specific liver health criteria, including a certain level of fat buildup and inflammation in the liver, along with some degree of liver scarring.
If you or someone you know is considering participating, you should be aware that participants will need to understand and agree to the study procedures. They should not have been involved in another clinical trial for at least 30 days prior, and they should not have significant alcohol use or other chronic liver diseases. Throughout the trial, participants will undergo evaluations and possibly liver biopsies to help doctors understand how well the new treatment works. This could be an important opportunity for individuals looking for new options to manage their liver health.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
- Exclusion Criteria:
- • 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
About Kowa Research Institute, Inc.
Kowa Research Institute, Inc. is a leading clinical research organization dedicated to advancing medical science through innovative research and development. As a subsidiary of Kowa Company, Ltd., a global pharmaceutical company, Kowa Research Institute specializes in conducting clinical trials across various therapeutic areas, including cardiovascular, metabolic, and infectious diseases. With a commitment to scientific integrity and patient safety, the organization collaborates with healthcare professionals and regulatory bodies to deliver high-quality research outcomes that drive the development of new therapies and improve patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ann Arbor, Michigan, United States
Madrid, , Spain
Malaga, , Spain
Buenos Aires, , Argentina
Los Angeles, California, United States
Tucson, Arizona, United States
Porto Alegre, , Brazil
Malaga, , Spain
Santander, Cantabria, Spain
Kawasaki, Kanagawa, Japan
Sevilla, , Spain
Santander, , Spain
Inverness, Florida, United States
Kurume, Fukuoka, Japan
Manassas, Virginia, United States
Buenos Aires, , Argentina
Toon, Ehime, Japan
Lincoln, California, United States
Inverness, Florida, United States
Jefferson City, Missouri, United States
Calgary, Alberta, Canada
San Antonio, Texas, United States
Kanazawa, Ishikawa, Japan
Clive, Iowa, United States
San Antonio, Texas, United States
Madrid, , Spain
Nagoya, Aichi, Japan
Yokohama, , Japan
Malaga, , Spain
Niigata City, Niigata, Japan
La Plata, Buenos Aires, Argentina
Pilar, , Argentina
Kurume, , Japan
Tokyo, , Japan
Toyoake, Aichi, Japan
Tucson, Arizona, United States
Marietta, Georgia, United States
Madrid, , Spain
Marietta, Georgia, United States
Saga, , Japan
Matsumoto, , Japan
Calgary, , Canada
Montreal, Quebec, Canada
Sevilla, , Spain
Toon, , Japan
Poway, California, United States
Madrid, , Spain
Chicoutimi, Quebec, Canada
Asahikawa, Hokkaido, Japan
Mar Del Plata, Buenos Aires, Argentina
Yokohama, Kanagawa, Japan
Colorado Springs, Colorado, United States
Huntington Park, California, United States
Jackson, Mississippi, United States
Seattle, Washington, United States
Santa Fe, , Argentina
San Antonio, Texas, United States
Ogaki City, Gifu, Japan
Jackson, Mississippi, United States
Marrero, Louisiana, United States
Marrero, Louisiana, United States
Morehead City, North Carolina, United States
Ocoee, Florida, United States
Quebec, , Canada
Montreal, , Canada
Jacksonville, Florida, United States
Miami, Florida, United States
Oxnard, California, United States
Asahikawa, , Japan
Okayama, , Japan
Tōon, , Japan
ōgaki, , Japan
Malaga, Andalucía, Spain
Morehead City, North Carolina, United States
Tucson, Arizona, United States
Waco, Texas, United States
Ocala, Florida, United States
New Albany, Indiana, United States
Huntington Park, California, United States
Ocoee, Florida, United States
San Antonio, Texas, United States
Waco, Texas, United States
Pensacola, Florida, United States
Columbia, Missouri, United States
Little Rock, Arkansas, United States
Columbus, Georgia, United States
Conway, Arkansas, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Pensacola, Florida, United States
Homewood, Alabama, United States
Los Angeles, California, United States
Tampa, Florida, United States
Columbus, Georgia, United States
Flowood, Mississippi, United States
Dayton, Ohio, United States
Cedar Park, Texas, United States
Dallas, Texas, United States
Garland, Texas, United States
Waco, Texas, United States
Richmond, Virginia, United States
Suffolk, Virginia, United States
Quebec City, Quebec, Canada
Greenbelt, Maryland, United States
Pharr, Texas, United States
Charlotte, North Carolina, United States
San Antonio, Texas, United States
San Marcos, Texas, United States
Sofia, Nikola, Bulgaria
Sofia, Nikola, Bulgaria
Sofia, Nikola, Bulgaria
Santander, Cabtabria, Spain
Coruna, , Spain
Garland, Texas, United States
Richmond, Virginia, United States
La Jolla, California, United States
Sofia, , Bulgaria
Salt Lake City, Utah, United States
Fukui, , Japan
Kawasaki, , Japan
Musashino, , Japan
Nagano, , Japan
Niigata, , Japan
Sapporo, , Japan
San Antonio, Texas, United States
Nagano, , Japan
Birmingham, Alabama, United States
Conway, Arkansas, United States
Tampa, Florida, United States
Marietta, Georgia, United States
Greenbelt, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Flowood, Mississippi, United States
Columbia, Missouri, United States
Charlotte, North Carolina, United States
Morehead City, North Carolina, United States
Dayton, Ohio, United States
Hershey, Pennsylvania, United States
Cedar Park, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
San Marcos, Texas, United States
Waco, Texas, United States
West Jordan, Utah, United States
Richmond, Virginia, United States
Suffolk, Virginia, United States
Caba, , Argentina
City Of Buenos Aires, , Argentina
Ciudad De Buenos Aires, , Argentina
Mar Del Plata, , Argentina
Mar Del Plata, , Argentina
Belem, , Brazil
Brasília, , Brazil
Ribeirao Preto, , Brazil
Salvador, , Brazil
São Paulo, , Brazil
Sofia, , Bulgaria
Sofia, , Bulgaria
Chicoutimi, , Canada
Asahikawa City, , Japan
Bunkyo Ku, , Japan
Fukui City, , Japan
Kawasaki, , Japan
Musashino City, , Japan
Niigata City, , Japan
Ogaki City, , Japan
Okayama City, , Japan
Saga City, , Japan
Sapporo City, , Japan
Coruna, , Spain
Zaragoza, , Spain
Boston, Massachusetts, United States
Nagoya, Aichi, Japan
Toyoake, Aichi, Japan
Takasaki, Gunma, Japan
Kure, Hiroshima, Japan
Sapporo, Hokkaido, Japan
Kanazawa, Ishikawa, Japan
Kawasaki, Kanagawa, Japan
Sendai, Miyagi, Japan
Hiroshima, , Japan
Nagano, , Japan
Niigata, , Japan
Oita, , Japan
Oita, , Japan
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Birmingham, Alabama, United States
Ocoee, Florida, United States
Boston, Massachusetts, United States
Charlotte, North Carolina, United States
Hershey, Pennsylvania, United States
San Antonio, Texas, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Mar Del Plata, Buenos Aires, Argentina
Pilar, Buenos Aires, Argentina
Santa Fe, Rosario, Argentina
Salvador, Bahia, Brazil
Brasília, Brasilia Df, Brazil
Belem, Para, Brazil
Porto Alegre, Porto Alegre Rs, Brazil
São Paulo, Sao Paulo Sp, Brazil
Ribeirao Preto, Sao Paulo, Brazil
Sofia, Sofia City, Bulgaria
Sofia, Sofia City, Bulgaria
Sofia, Sofia City, Bulgaria
Fukui City, Fukui, Japan
Takasaki Shi, Gumna, Japan
Hiroshima City, Hiroshima, Japan
Kure Shi, Hiroshima, Japan
Sapporo City, Hokkaido, Japan
Sapporo City, Hokkaido, Japan
Kawasaki, Kanagawa, Japan
Sendai City, Miyagi, Japan
Matsumoto Shi, Nagano, Japan
Nagano Shi, Nagano, Japan
Niigata City, Niigata, Japan
Okayama City, Okayama, Japan
Saga City, Saga, Japan
Musashino City, Tokyo, Japan
Bunkyo Ku, Toyko, Japan
Zaragoza, Zargoza, Spain
A Coruna, , Spain
Patients applied
Trial Officials
Shona Pendse, MD, MMSc
Study Chair
Kowa Research Institute, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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