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Completed
NCT05327127
Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis
Conditions: NASH
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 228
Sponsor: Kowa Research Institute, Inc.
Location: Adobe Clinical Research, LLC Tucson Arizona
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 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
Source: ClinicalTrials.gov (NCT05327127). StuddyBuddy aggregates publicly available trial information.