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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05327127). StuddyBuddy aggregates publicly available trial information.