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NCT06247735 · ClinicalTrials.gov registry record · Phase 2

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.

A Phase 2 study of Primary Biliary Cholangitis, sponsored by Kowa Research Institute.

Active
Registry status
Phase 2
Development phase
46
Enrollment target
20
Study locations

NCT06247735 is a Phase 2 study of Primary Biliary Cholangitis that is active but no longer recruiting, run by Kowa Research Institute. The registered enrollment target is 46 participants, below the 201-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT06247735, a Phase 2 study of Primary Biliary Cholangitis, is active but no longer recruiting, sponsored by Kowa Research Institute.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
46 participants
Enrollment target
20
Study locations

Study Summary

Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.

Conditions Studied

Primary Biliary Cholangitis

Interventions

  • DRUG Placebo
  • DRUG K-808 (Dose A)
  • DRUG K-808 (Dose B)

Study Locations (20)

California

  • Southern California Research Center - Coronado - Coronado
  • Cedars-Sinai Medical Center - Los Angeles
  • Velocity Clinical Research - Santa Ana

Florida

  • University of Florida Hepatology Research at CTRB - Gainesville
  • Florida Research Institute - Lakewood Rch
  • University of Miami Leonard M. Miller School of Medicine - Miami

Virginia

  • UVA Health - University of Virginia Health System - Charlottesville
  • Gastrointestinal and Liver Specialists of Tidewater - Digestive and Liver Disease Specialists - Norfolk

Arizona

  • UA Thomas D. Boyer Liver Institute - Tucson

Colorado

  • Peak Gastroenterology Associates Colorado Springs - Colorado Springs

Illinois

  • Springfield Clinic - Springfield

Maryland

  • Mercy Medical Center - Mcauley Plaza - Baltimore

Nebraska

  • CommonSpirit Health Research Institute - Omaha

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2024-02-07
Est. Completion 2026-06
Phase Phase 2

Sponsor

Kowa Research Institute

44 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06247735

The ClinicalTrials.gov registry entry for NCT06247735 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 201-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (77% lower). The listed sponsor is Kowa Research Institute, which has 44 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Primary Biliary Cholangitis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT06247735 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Florida, Virginia.

Frequently Asked Questions

What is clinical trial NCT06247735 about?

NCT06247735 is a clinical study titled "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.". Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.

What is the current status of trial NCT06247735?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2024-02-07. Estimated completion is 2026-06.

What conditions does trial NCT06247735 study?

This clinical trial studies the following conditions: Primary Biliary Cholangitis.

What interventions are being tested in trial NCT06247735?

The interventions under investigation include: Placebo (DRUG), K-808 (Dose A) (DRUG), K-808 (Dose B) (DRUG).

Who is sponsoring clinical trial NCT06247735?

This trial is sponsored by Kowa Research Institute, which has 44 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06247735 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.