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Evaluating a new treatment for liver disease

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

Phase 2 Interventional Kowa Research Institute, Inc. · NCT05327127

This study is testing a new combination treatment for adults with liver disease caused by fat buildup to see if it can improve their liver health and reduce scarring.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorKowa Research Institute, Inc. Industry-sponsored
Locations108 sites (Birmingham, Alabama and 107 other locations)
Trial IDNCT05327127 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of a combination therapy using two investigational products, K-877-ER and CSG452, for treating adult patients with Nonalcoholic Steatohepatitis (NASH) who have liver fibrosis. Participants will undergo liver biopsies to assess their condition and will be randomly assigned to receive either the combination therapy or a placebo. The study aims to determine if this new treatment can improve liver health and reduce fibrosis in affected individuals.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of NASH and liver fibrosis stage 1 to 3.

Not a fit: Patients with other chronic liver diseases or those who consume excessive alcohol may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve liver health and outcomes for patients with NASH and liver fibrosis.

How similar studies have performed: While there have been studies on NASH treatments, this specific combination therapy approach is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 107 other locations

+58 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions NASH
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.