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

Phase 2

Active, not recruiting

• Conditions: NASH
• Interventions: Drug: K-877-ER; Drug: CSG452; Drug: Placebo

• Registration Number: NCT05327127
• Lead Sponsor: Kowa Research Institute, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-04-06
• Study First Posted: 2022-04-14
• Study Start: 2022-11-14
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-27
• Primary Completion: 2026-02
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 228

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
K-001	K-877-ER	K-877-ER and CSG452 Once daily (QD)
K-001	CSG452	K-877-ER and CSG452 Once daily (QD)
K-877-ER	K-877-ER	K-877-ER and CSG452 Placebo QD
K-877-ER	Placebo	K-877-ER and CSG452 Placebo QD
CSG452	Placebo	CSG452 and K-877-ER Placebo QD
Placebo	Placebo	-
CSG452	CSG452	CSG452 and K-877-ER Placebo QD

Primary Outcome Measures

Name	Time	Method
Improvement in disease activity and no worsening of liver fibrosis (Yes/No)	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 Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Related Adverse Events (AE)	52 Weeks	Time frame is 52 weeks unless an unresolved AE is still being followed

Trial Locations

Locations (74)

Adobe Clinical Research, LLC; 🇺🇸 Tucson, Arizona, United States

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

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