Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.
Public ClinicalTrials.gov record NCT06247735. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Randomized, Placebo-controlled, Parallel Group, Multicenter 12-week Study With a 52-week Extension to Evaluate the Efficacy and Safety of Two Doses of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Inadequate Response to Ursodeoxycholic Acid and/or Obeticholic Acid Treatment
Study identification
- NCT ID
- NCT06247735
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Kowa Research Institute, Inc.
- Industry
- Enrollment
- 46 participants
Conditions and interventions
Conditions
Interventions
- K-808 (Dose A) Drug
- K-808 (Dose B) Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 6, 2024
- Primary completion
- Jun 25, 2025
- Completion
- Jun 30, 2026
- Last update posted
- Jun 25, 2026
2024 – 2026
United States locations
- U.S. sites
- 21
- U.S. states
- 16
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UA Thomas D. Boyer Liver Institute | Tucson | Arizona | 85724 | — |
| Southern California Research Center - Coronado | Coronado | California | 92118 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Velocity Clinical Research | Santa Ana | California | 92704 | — |
| Peak Gastroenterology Associates Colorado Springs | Colorado Springs | Colorado | 80921 | — |
| University of Florida Hepatology Research at CTRB | Gainesville | Florida | 32610 | — |
| Florida Research Institute | Lakewood Rch | Florida | 34211 | — |
| University of Miami Leonard M. Miller School of Medicine | Miami | Florida | 33136 | — |
| Springfield Clinic | Springfield | Illinois | 62702 | — |
| Mercy Medical Center - Mcauley Plaza | Baltimore | Maryland | 21202 | — |
| CommonSpirit Health Research Institute | Omaha | Nebraska | 68124 | — |
| New York University Hepatology Associates | New York | New York | 10016 | — |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | — |
| Rapid City Medical Center | Rapid City | South Dakota | 57701 | — |
| Vanderbilt Digestive Disease Center | Nashville | Tennessee | 37232 | — |
| Pioneer Research Solutions | Houston | Texas | 77099 | — |
| UVA Health - University of Virginia Health System | Charlottesville | Virginia | 22908 | — |
| Gastrointestinal and Liver Specialists of Tidewater - Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | — |
| Liver Institute Northwest | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 17 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06247735, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 25, 2026 · Synced Jul 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06247735 live on ClinicalTrials.gov.