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Active Not RecruitingNCT05327127

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

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

Status
Active Not Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
228 (actual)
Sponsor
Kowa Research Institute, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

Conditions

Interventions

TypeNameDescription
DRUGK-877-ERK-877-ER tablet
DRUGCSG452CSG452 tablet
DRUGPlaceboPlacebo tablet

Timeline

Start date
2022-11-14
Primary completion
2026-05-05
Completion
2026-06-02
First posted
2022-04-14
Last updated
2026-03-27

Locations

77 sites across 6 countries: United States, Argentina, Brazil, Canada, Japan, Spain

Regulatory

Source: ClinicalTrials.gov record NCT05327127. Inclusion in this directory is not an endorsement.

Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis (NCT05327127) · Clinical Trials Directory