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

Completed · Phase 2 · Has a placebo group

Conditions studied: NASH

In brief

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

Key facts

Study ID

NCT05327127

Run by

Kowa Research Institute, Inc.

People needed

228

Starts

2022-11-14

Expected to finish

2026-06-03

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• Arizona Liver Health — Tucson, Arizona, United States
• Arcare Center for Clinical Research — Little Rock, Arkansas, United States
• Clinical Trials Research — Lincoln, California, United States
• United Clinical Research Institute — Los Alamitos, California, United States
• Velocity Clinical Research — Los Angeles, California, United States
• Alliance Clinical Research — Poway, California, United States
• Nature Coast Clinical Research, LLC — Inverness, Florida, United States
• ENCORE Borland Groover Clinical Research — Jacksonville, Florida, United States
• Miami Clinical Research — Miami, Florida, United States
• Ocala GI Research — Ocala, Florida, United States
• Sensible Healthcare Clinical Research, LLC — Ocoee, Florida, United States
• Centricity Research — Columbus, Georgia, United States
• Gastrointestinal Specialists of Georgia, PC — Marietta, Georgia, United States
• Iowa Digestive Disease Center — Clive, Iowa, United States
• Tandem Clinical Research, LLC — Marrero, Louisiana, United States
• Mid-Atlantic GI Research, LLC — Greenbelt, Maryland, United States
• Boston Medical Center Boston University Chobanian & Avedisian School of Medicine — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• GI Alliance Research — Flowood, Mississippi, United States
• GI Associates Research, LLC — Columbia, Missouri, United States
• Jefferson City Medical Group — Jefferson City, Missouri, United States
• Lucas Research, Inc. — Morehead City, North Carolina, United States
• DSI Research Northridge, LLC — Dayton, Ohio, United States
• Penn State Health/Penn State College of Medicine — Hershey, Pennsylvania, United States
• Adobe Clinical Research, LLC — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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