Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

Summary

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

Official Title

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

Keywords

NASH, Liver Cirrhosis, 6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol, CSG452

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

  • UCSD NAFLD Research Center accepting new patients
    La Jolla California 92037 United States
  • National Research Institute accepting new patients
    Los Angeles California 90057 United States
  • Alliance Clinical Research accepting new patients
    Poway California 92064 United States
  • National Research Institute accepting new patients
    Huntington Park California 90255 United States
  • United Clinical Research Institute accepting new patients
    Los Alamitos California 90720 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kowa Research Institute, Inc.
ID
NCT05327127
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated