A Phase 2, Multicenter, Placebo-Controlled, Randomized, Double-Blind, 48-Week Study to Evaluate the Efficacy and Safety of Combination Therapy of K-877-ER and CSG452 in Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH) with Liver Fibrosis

JRCT ID: jRCT2031230056

Registered date:29/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: NASH
• Date of first enrollment: 03/08/2023
• Target sample size: 300
• Countries of recruitment: United States,Japan,Canada,Japan,Spain,Japan,Bulgaria,Japan,Argentina,Japan,Brazil,Japan
• Study type: Interventional

Intervention(s)

- K-001(K-877 ER 0.4 mg +CSG452 20 mg) group: oral doses once daily
- K-877-ER(K-877 ER 0.4 mg +CSG452 placebo) group: oral doses once daily
- CSG452(K-877 ER placebo +CSG452 20mg) group: oral doses once daily
- Placebo(K-877 ER placebo +CSG452 placebo) group: oral doses once daily

Outcome(s)

• Primary Outcome: The primary efficacy endpoint is improvement from Baseline (liver biopsy at the Baseline Biopsy Visit, or a historical liver biopsy obtained within 24 weeks of randomization) in disease activity and no worsening of liver fibrosis on the NASH Clinical Research Network (CRN) fibrosis score at Week 48. The improvement in disease activity is defined as improvement in NAFLD Activity Score (NAS) >=2 points. The worsening of fibrosis is defined as any numerical increase in the stage.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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 significant amounts of alcohol as defined in clinical study protocol
-Evidence of other forms of chronic liver disease as defined in clinical study protocol

Related Information

• Primary Sponsor: Tanigawa Ryohei
• Secondary Sponsor: Kowa Company, Ltd.
• Secondary ID(s): NCT05327127