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NCT06060665 · ClinicalTrials.gov registry record · Phase 3

Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)

A Phase 3 study of Primary Biliary Cholangitis, sponsored by Gilead Sciences.

Active
Registry status
Phase 3
Development phase
90
Enrollment target
20
Study locations

NCT06060665 is a Phase 3 study of Primary Biliary Cholangitis that is active but no longer recruiting, run by Gilead Sciences. The registered enrollment target is 90 participants, below the 195-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT06060665, a Phase 3 study of Primary Biliary Cholangitis, is active but no longer recruiting, sponsored by Gilead Sciences.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
90 participants
Enrollment target
20
Study locations

Study Summary

To Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA). The primary objective is to evaluate the effect of seladelpar treatment at Week 52 compared to placebo based on normalization of alkaline phosphatase (ALP) defined by a composite endpoint of ALP ≤ 1.0× upper limit of normal (ULN) and ≥ 15% decrease from baseline in PBC participants with an ALP value greater than ULN but less than 1.67× ULN.

Conditions Studied

Primary Biliary Cholangitis

Interventions

  • DRUG Placebo
  • DRUG Seladelpar 10 mg

Study Locations (20)

Florida

  • Florida Research Institute - Lakewood Rch
  • University of Miami - Schiff Center for Liver Diseases - Miami
  • Gastro Health Research - Miami
  • Covenant Metabolic Specialists, LLC - Sarasota
  • Covenant Metabolic Specialists, LLC - Tampa

California

  • California Liver Research Institute - Pasadena
  • University of California (UC) Davis Medical Center - Sacramento
  • California Pacific Medical Center - San Francisco

Colorado

  • University of Colorado Denver - School of Medicine - Anschutz Medical Campus - Aurora
  • South Denver Gastroenterology - Englewood

Louisiana

  • Tulane University Medical Center - New Orleans
  • Louisiana Research Center, LLC - Shreveport

Massachusetts

  • Massachusetts General Hospital - Boston
  • Beth Israel Deaconess Medical Center - Boston

Arizona

  • The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver Health - Chandler

Georgia

  • Digestive Healthcare of Georgia - Atlanta

Illinois

  • Northwestern Medicine Clinical Research Unit (CRU) - Chicago

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2023-09-05
Est. Completion 2026-06
Phase Phase 3

Sponsor

Gilead Sciences

504 total trials

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What the Registry Record Tells You About NCT06060665

The ClinicalTrials.gov registry entry for NCT06060665 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 195-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (54% lower). The listed sponsor is Gilead Sciences, which has 504 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 2 interventions - of which Placebo is the first listed.

NCT06060665 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT06060665 about?

NCT06060665 is a clinical study titled "Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)". To Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA). The primary objective is to evaluate the effect of seladelpar treatment at Week 52 comp...

What is the current status of trial NCT06060665?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2023-09-05. Estimated completion is 2026-06.

What conditions does trial NCT06060665 study?

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

What interventions are being tested in trial NCT06060665?

The interventions under investigation include: Placebo (DRUG), Seladelpar 10 mg (DRUG).

Who is sponsoring clinical trial NCT06060665?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06060665 being conducted?

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

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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.