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

NCT05327127 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2026-03-27

No results posted yet for this study

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

  • NASH

Interventions

DRUG

K-877-ER

K-877-ER tablet

DRUG

CSG452

CSG452 tablet

DRUG

Placebo

Placebo tablet

Sponsors & Collaborators

  • Kowa Research Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Shona Pendse, MD, MMSc · Kowa Research Institute, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-14
Primary Completion
2026-05-05
Completion
2026-06-02
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Japan
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05327127 on ClinicalTrials.gov