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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 12 weeks of randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
Study Summary
This trial will study the use of two investigational drugs to treat adults with NASH.
Who is the study for?
Adults with Nonalcoholic Steatohepatitis (NASH) and liver fibrosis can join this trial. They must have a minimum score on a liver health test, not be in another study recently, and not drink significant alcohol. Other chronic liver diseases or conditions outlined in the protocol also disqualify them.Check my eligibility
What is being tested?
The trial is testing two experimental drugs, K-877-ER and CSG452, against a placebo to see if they're effective for treating NASH with liver fibrosis. Participants will randomly receive either the drugs or placebo.See study design
What are the potential side effects?
Potential side effects are not specified here but may include typical drug reactions such as gastrointestinal issues, fatigue, allergic responses, or other organ-related inflammation due to the nature of the medications being tested.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My liver biopsy shows a NAS of 4 or more with some steatosis, inflammation, and ballooning.
Select...
My liver fibrosis stage is between 1 and below 4.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improvement in disease activity and no worsening of liver fibrosis (Yes/No)
Secondary outcome measures
Number of Participants With Treatment-Related Adverse Events (AE)
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: K-877-ERExperimental Treatment2 Interventions
K-877-ER and CSG452 Placebo QD
Group II: K-001Experimental Treatment2 Interventions
K-877-ER and CSG452 Once daily (QD)
Group III: CSG452Experimental Treatment2 Interventions
CSG452 and K-877-ER Placebo QD
Group IV: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
K-877-ER
2023
Completed Phase 1
~30
Tofogliflozin
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Kowa Research Institute, Inc.Lead Sponsor
44 Previous Clinical Trials
16,120 Total Patients Enrolled
Shona Pendse, MD, MMScStudy ChairKowa Research Institute, Inc.
5 Previous Clinical Trials
614 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My liver biopsy shows a NAS of 4 or more with some steatosis, inflammation, and ballooning.I have a long-term liver condition.My liver fibrosis stage is between 1 and below 4.You have been drinking a lot of alcohol recently or are currently drinking heavily.
Awards:
This trial has 0 awards, including:Research Study Groups:
This trial has the following groups:- Group 1: CSG452
- Group 2: K-001
- Group 3: K-877-ER
- Group 4: Placebo
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Nonalcoholic Steatohepatitis Patient Testimony for trial: Trial Name: NCT05327127 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a possibility of enrolling new participants in this experiment?
"That is correct. According to clinicaltrials.gov, this research trial is currently accepting patients. The study was first released on September 1st 2022 and recently modified on August 16th 2022. 400 participants must be recruited from 6 distinct medical sites in order to complete the investigation."
Answered by AI
Has the FDA sanctioned CSG452 for therapeutic purposes?
"Due to lacking evidence of CSG452's efficacy, the safety score assigned by Power is 2. However, Phase 2 trials have demonstrated that it can be taken with minimal risk."
Answered by AI
What is the current size of the study population?
"Affirmative, the information available on clinicaltrials.gov points to this trial actively seeking participants. This study was initially posted on September 1st 2022 and has since been amended as of August 16th 2022. 400 patients are required between 6 distinct sites for successful completion."
Answered by AI
How many healthcare facilities are facilitating this trial?
"Velocity Research in Los Angeles, ENCORE Borland Groover Clinical Research in Michigan, and United Clinical Research Institute in North carolina are among the 6 locations conducting this clinical trial."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
What site did they apply to?
Arcare Center for Clinical Research
Tampa General Medical Group
Other
Sensible Healthcare Clinical Research
Why did patients apply to this trial?
Trying to get different help. I was surprised by my diagnosis, want to avoid further deterioration and to improve me health.
PatientReceived 2+ prior treatments
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