Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of Primary Biliary Cholangitis, sponsored by Gilead Sciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2023-09-05 |
| Est. Completion | 2026-06 |
| Phase | Phase 3 |
What the registry record for NCT06060665 still lists
NCT06060665 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 195-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (54% lower).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
Similar trials for Primary Biliary Cholangitis
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 NCT06060665's enrollment target sits among peer trials
90 6th of 8 higher than 3 of 8 other Primary Biliary Cholangitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Biliary Cholangitis 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
-
Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
RECRUITING · Phase 3
-
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
RECRUITING · Phase 3
-
A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
ACTIVE NOT RECRUITING · Phase 3
-
ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
COMPLETED · Phase 3
-
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
RECRUITING · Phase 2
-
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02521311 · 90 participants · Phase 2
Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)
- NCT02939573 · 90 participants · Phase 2
A Randomized Multicenter Study for Isolated Skin Vasculitis
- NCT03128879 · 90 participants · Phase 2
Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL
- NCT03184038 · 90 participants · NA
Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI