Status:
ACTIVE_NOT_RECRUITING
Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis
Lead Sponsor:
Kowa Research Institute, Inc.
Conditions:
NASH
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT05327127
Start Date
November 14 2022
End Date
March 1 2026
Last Update
June 27 2025
Active Locations (77)
Enter a location and click search to find clinical trials sorted by distance.
1
Adobe Clinical Research, LLC
Tucson, Arizona, United States, 85712
2
Arizona Liver Health
Tucson, Arizona, United States, 85712
3
Arcare Center for Clinical Research
Little Rock, Arkansas, United States, 72205
4
Clinical Trials Research
Lincoln, California, United States, 95648