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

Description

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

Conditions

NASH

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Study Overview

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Study Details

Study overview

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

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

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

Condition
NASH
Intervention / Treatment

-

Contacts and Locations

Birmingham

Birmingham Digestive Health Research, Birmingham, Alabama, United States, 35209

Tucson

Advanced Clinical Therapeutics, Tucson, Arizona, United States, 85712

Tucson

Arizona Liver Health, Tucson, Arizona, United States, 85712

Conway

ARcare Center for Clinical Reseach, Conway, Arkansas, United States, 72032

Little Rock

ARcare Center for Clinical Research, Little Rock, Arkansas, United States, 72205

Huntington Park

National Research Institute, Huntington Park, California, United States, 90255

La Jolla

UCSD NAFLD Research Center, La Jolla, California, United States, 92037

Lincoln

Clinical Trials Research, Lincoln, California, United States, 95648

Los Alamitos

United Clinical Research Institute, Los Alamitos, California, United States, 90720

Los Angeles

National Research Institute, Los Angeles, California, United States, 90057

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kowa Research Institute, Inc.,

Shona Pendse, MD, MMSc, STUDY_CHAIR, Kowa Research Institute, Inc.

Study Record Dates

2026-03