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
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- NASH
- Sponsor
- Kowa Research Institute, Inc.
- Enrollment
- 228
- Locations
- 74
- Primary Endpoint
- Improvement in disease activity and no worsening of liver fibrosis (Yes/No)
- Status
- Active, not recruiting
- Last Updated
- 10 months ago
Overview
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).
Investigators
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
Arms & Interventions
K-877-ER
K-877-ER and CSG452 Placebo QD
Intervention: Placebo
CSG452
CSG452 and K-877-ER Placebo QD
Intervention: CSG452
K-001
K-877-ER and CSG452 Once daily (QD)
Intervention: K-877-ER
K-001
K-877-ER and CSG452 Once daily (QD)
Intervention: CSG452
K-877-ER
K-877-ER and CSG452 Placebo QD
Intervention: K-877-ER
CSG452
CSG452 and K-877-ER Placebo QD
Intervention: Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Improvement in disease activity and no worsening of liver fibrosis (Yes/No)
Time Frame: Baseline to Week 48
The improvement in disease activity is defined as decrease in NAFLD Activity Score (NAS) ≥2 points. The worsening of fibrosis is defined as any numerical increase in the stage.
Secondary Outcomes
- Number of Participants With Treatment-Related Adverse Events (AE)(52 Weeks)