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NCT05327127 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis
A Phase 2 study of NASH, sponsored by Kowa Research Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 228
- Enrollment target
- 20
- Study locations
NCT05327127: Active Phase 2 study of NASH, sponsored by Kowa Research Institute.
NCT05327127 is a Phase 2 study of NASH that is active but no longer recruiting, run by Kowa Research Institute. The registered enrollment target is 228 participants, roughly in line with the 229-participant average among 10 other NASH trials with a reported enrollment target. The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05327127, a Phase 2 study of NASH, is active but no longer recruiting, sponsored by Kowa Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 228 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG K-877-ER
- DRUG CSG452
Study Locations (20)
Florida
- Nature Coast Clinical Research, LLC - Inverness
- ENCORE Borland Groover Clinical Research - Jacksonville
- Miami Clinical Research - Miami
- Ocala GI Research - Ocala
- Sensible Healthcare Clinical Research, LLC - Ocoee
California
- Clinical Trials Research - Lincoln
- United Clinical Research Institute - Los Alamitos
- Velocity Clinical Research - Los Angeles
- Alliance Clinical Research - Poway
Arizona
- Adobe Clinical Research, LLC - Tucson
- Arizona Liver Health - Tucson
Georgia
- Centricity Research - Columbus
- Gastrointestinal Specialists of Georgia, PC - Marietta
Arkansas
- Arcare Center for Clinical Research - Little Rock
Iowa
- Iowa Digestive Disease Center - Clive
Louisiana
- Tandem Clinical Research, LLC - Marrero
Maryland
- Mid-Atlantic GI Research, LLC - Greenbelt
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 228 participants |
| Start Date | 2022-11-14 |
| Est. Completion | 2026-03 |
| Phase | Phase 2 |
What the registry record for NCT05327127 still lists
NCT05327127 is an interventional study that assigns participants to a tested intervention. The registered 228 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 229-participant average among 10 other NASH trials with a reported enrollment target.
The record links to 1 condition, with NASH appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05327127 names 20 study sites across 11 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05327127 about?
NCT05327127 is a clinical study titled "Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis". A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).
What is the current status of trial NCT05327127?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 228 participants. The study started on 2022-11-14. Estimated completion is 2026-03.
What conditions does trial NCT05327127 study?
This clinical trial studies the following conditions: NASH.
What interventions are being tested in trial NCT05327127?
The interventions under investigation include: Placebo (DRUG), K-877-ER (DRUG), CSG452 (DRUG).
Who is sponsoring clinical trial NCT05327127?
This trial is sponsored by Kowa Research Institute, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05327127 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for NASH
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05327127's enrollment target sits among peer trials
228 5th of 10 higher than 6 of 10 other NASH trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NASH trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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