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OpenTrials
Completed

NCT Number: NCT05327127

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

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

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Key information

Conditions

NASH

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CINME - Centro De Investigaciones Metabolicas, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

K-877-ER

Drug

K-877-ER tablet

CSG452

Drug

CSG452 tablet

Placebo

Drug

Placebo tablet

Primary outcomes

  1. Improvement in disease activity and no worsening of liver fibrosis (Yes/No)

    Time frame: Baseline to Week 48

    The improvement in disease activity is defined as decrease in NAFLD Activity Score (NAS) ≥2 points. The worsening of fibrosis is defined as any numerical increase in the stage.

Secondary outcomes

  1. Number of Participants With Treatment-Related Adverse Events (AE)

    Time frame: 52 Weeks

    Time frame is 52 weeks unless an unresolved AE is still being followed

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 14, 2022
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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