NASH
Conditions
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).
Sponsors
Kowa Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in disease activity and no worsening of liver fibrosis (Yes/No) | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events (AE) | 52 Weeks | Time frame is 52 weeks unless an unresolved AE is still being followed |
Countries
Argentina, Brazil, Canada, Japan, Spain, United States
Contacts
STUDY_CHAIRShona Pendse, MD, MMSc
Kowa Research Institute, Inc.
Outcome results
None listed