The trial is taking place at:
S

Sensible Healthcare Clinical Research | Ocoee, FL

Veeva-enabled site

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

Kowa logo

Kowa

Status and phase

Enrolling
Phase 2

Conditions

NASH

Treatments

Drug: Placebo
Drug: K-877-ER
Drug: CSG452

Study type

Interventional

Funder types

Industry

Identifiers

NCT05327127
K-001-201

Details and patient eligibility

About

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

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

300 participants in 4 patient groups, including a placebo group

K-001
Experimental group
Description:
K-877-ER and CSG452 Once daily (QD)
Treatment:
Drug: CSG452
Drug: K-877-ER
K-877-ER
Experimental group
Description:
K-877-ER and CSG452 Placebo QD
Treatment:
Drug: K-877-ER
Drug: Placebo
CSG452
Experimental group
Description:
CSG452 and K-877-ER Placebo QD
Treatment:
Drug: CSG452
Drug: Placebo
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

61

Loading...

Central trial contact

Director, Clinical Operations

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems