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Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis
Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis

NCT05327127

CompletedPhase 2

Sponsor: Kowa Research Institute, Inc.

Conditions: NASH

Interventions: K-877-ER, CSG452, Placebo

Countries: United States, Argentina, Brazil, Canada, Japan, Spain

A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (77)
  • Tucson, Arizona, United States
  • Tucson, Arizona, United States
  • Little Rock, Arkansas, United States
  • Lincoln, California, United States
  • Los Alamitos, California, United States
  • Los Angeles, California, United States
  • Poway, California, United States
  • Inverness, Florida, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Ocala, Florida, United States
  • Ocoee, Florida, United States
  • Columbus, Georgia, United States
  • Marietta, Georgia, United States
  • Clive, Iowa, United States
  • Marrero, Louisiana, United States
  • Greenbelt, Maryland, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Flowood, Mississippi, United States
  • Columbia, Missouri, United States
  • Jefferson City, Missouri, United States
  • Morehead City, North Carolina, United States
  • Dayton, Ohio, United States
  • Hershey, Pennsylvania, United States
  • Cedar Park, Texas, United States
  • Dallas, Texas, United States
  • Garland, Texas, United States
  • Pharr, Texas, United States
  • San Antonio, Texas, United States
  • + 47 more on CT.gov