NCT05327127CompletedPhase 2
Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis
Study to Evaluate the Efficacy and Safety of Combination Therapy of K-877-ER and CSG452 in Participants With Noncirrhotic Nonalcoholic Steatohepatitis (NASH) With Liver Fibrosis
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 228 (actual)
- First submitted
- 2 Mar 2022
- Start date
- 14 Nov 2022
- Primary completion date
- 20 May 2026
- Lead sponsor
- Kowa Research Institute, Inc.
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05327127
- EU CT number
- 2023-508104-38-00
- EudraCT number
- 2021-003901-23
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 228
- From 14 Nov 2022 to the primary completion date, 20 May 2026
- 83 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another clinical trial involving an investigational agent within 30 days prior to signing the Informed Consent Form (ICF) for this study
Other illness
- Evidence of other forms of chronic liver disease as defined in clinical study protocol
Other
- Ongoing or recent consumption of Greater than moderate amounts of alcohol as defined in clinical study protocol
- Does not meet any other exclusion criteria outlined in clinical study protocol
Who the study is looking for
- 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
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (83)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Italiano de Buenos Aires Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aires | Argentina | Unknown status |
| Cinme - Centro de Investigaciones Metabolicas Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aires | Argentina | Unknown status |
| Hospital Italiano de La Plata Coordinator of this site? Confirm its status | La Plata | Argentina | Unknown status |
| Instituto de Investigaciones clinicas de Mar del Plata Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Unknown status |
| Hospital Universitario Austra Coordinator of this site? Confirm its status | Pilar | Argentina | Unknown status |
| Hospital Provincial del Centenario Coordinator of this site? Confirm its status | Santa Fe | Argentina | Unknown status |
| Acibadem City Clinic Diagnostic And Consultation Center Ltd. Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| Acibadem City Clinic Tokuda University Hospital EAD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Diagnostic-Consultative Center Alexandrovska EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Hospital Universitário João de Barros Barreto Coordinator of this site? Confirm its status | Belém | Brazil | Unknown status |
| Clínica de Endocrinologia e Metabologia Ltda Coordinator of this site? Confirm its status | Brasília | Brazil | Unknown status |
| Hospital de Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital Alianca Rede D 'Or Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Ecogene-21 Coordinator of this site? Confirm its status | Chicoutimi | Canada | Unknown status |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Completed |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Unviersitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Completed |
| Asahikawa Medical University Hospital Coordinator of this site? Confirm its status | Asahikawa | Japan | Unknown status |
| Nippon Medical School Hospital Coordinator of this site? Confirm its status | Bunkyō City | Japan | Unknown status |
| Fukui-ken Saiseikai Hospital Coordinator of this site? Confirm its status | Fukui-shi | Japan | Unknown status |
| Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Kanazawa University Hospital Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| St Marianna University School of Medicine Coordinator of this site? Confirm its status | Kawasaki | Japan | Unknown status |
| SHIN-YURIGAOKA General Hospital Coordinator of this site? Confirm its status | Kawasaki | Japan | Unknown status |
| NHO Kure Medical Center and Chugoku Cancer Center Coordinator of this site? Confirm its status | Kure Shi | Japan | Unknown status |
| Shinshu University Hospital Coordinator of this site? Confirm its status | Matsumoto-shi | Japan | Unknown status |
| Japanese Red Cross Musashino Hospital Coordinator of this site? Confirm its status | Musashino | Japan | Unknown status |
| Nagano Municipal Hospital Coordinator of this site? Confirm its status | Nagano | Japan | Unknown status |
| Nagoya University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Saiseikai Niigata Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| Ogaki Municipal Hospital Coordinator of this site? Confirm its status | Ōgaki | Japan | Unknown status |
| Oita Cardiovascular Hospital Coordinator of this site? Confirm its status | Ōita | Japan | Unknown status |
| Kawasaki Medical School General Medical Center Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Saga University Hospital Coordinator of this site? Confirm its status | Saga | Japan | Unknown status |
| JCHO Hokkaido Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Tohoku Rosai Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| NHO Takasaki General Medical Center Coordinator of this site? Confirm its status | Takasaki Shi | Japan | Unknown status |
| Ehime University Hospital Coordinator of this site? Confirm its status | Tōon | Japan | Unknown status |
| Fujita Health University Hospital Coordinator of this site? Confirm its status | Toyoake | Japan | Unknown status |
| Yokohama City University Hospital Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Boston Medical Center Boston University Chobanian & Avedisian School of Medicine Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| GI Alliance Research Coordinator of this site? Confirm its status | Cedar Park | United States | Unknown status |
| Iowa Digestive Disease Center Coordinator of this site? Confirm its status | Clive | United States | Unknown status |
| GI Associates Research, LLC Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Centricity Research Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| GI Alliance Research Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| DSI Research Northridge LLC Coordinator of this site? Confirm its status | Dayton | United States | Unknown status |
| GI Alliance Research Coordinator of this site? Confirm its status | Flowood | United States | Unknown status |
| GI Alliance Research Coordinator of this site? Confirm its status | Garland | United States | Unknown status |
| Mid-Atlantic GI Research, LLC Coordinator of this site? Confirm its status | Greenbelt | United States | Unknown status |
| Penn State Health/Penn State College of Medicine Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| Nature Coast Clinical Research LLC Coordinator of this site? Confirm its status | Inverness | United States | Unknown status |
| ENCORE Borland Groover Clinical Research Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Jefferson City Medical Group Coordinator of this site? Confirm its status | Jefferson City | United States | Unknown status |
| Clinical Trials Research Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
| ARcare Center for Clinical Research Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| United Clinical Research Institute Coordinator of this site? Confirm its status | Los Alamitos | United States | Unknown status |
| Velocity Clinical Research Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Gastrointestinal Specialists of Georgia, PC Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| Tandem Clinical Research, LLC Coordinator of this site? Confirm its status | Marrero | United States | Unknown status |
| Miami Clinical Research Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Lucas Research, Inc. Coordinator of this site? Confirm its status | Morehead City | United States | Unknown status |
| Ocala GI Research Coordinator of this site? Confirm its status | Ocala | United States | Unknown status |
| Sensible Healthcare Clinical Research, LLC Coordinator of this site? Confirm its status | Ocoee | United States | Unknown status |
| GLRI McAllen Research Coordinator of this site? Confirm its status | Pharr | United States | Unknown status |
| Alliance Clinical Research Coordinator of this site? Confirm its status | Poway | United States | Unknown status |
| North Richmond Health Research Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| GI Select Health Research Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Endeavor Clinical Trials Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Northeast Clinical Rsearch of San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Liver Institute Northwest Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Centricity Coordinator of this site? Confirm its status | Suffolk | United States | Unknown status |
| Adobe Clinical Research LLC Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Arizona Liver Health Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Impact Research Institute Coordinator of this site? Confirm its status | Waco | United States | Unknown status |
| Digestive Health Research of Central Texas, LLC Coordinator of this site? Confirm its status | Waco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.