Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)
Public ClinicalTrials.gov record NCT06060665. 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.
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Official title
IDEAL: A 52-week, Double-blind, Placebo-controlled, Randomized, Phase 3 Study Intended 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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06060665
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 96 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- 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
- Sep 5, 2023 (Actual)
- Primary completion
- May 6, 2026 (Actual)
- Completion
- May 6, 2026 (Actual)
- Last update posted
- Jun 4, 2026
2023 – 2026
United States locations
- U.S. sites
- 43
- U.S. states
- 19
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver Health | Chandler | Arizona | 85224 | — |
| California Liver Research Institute | Pasadena | California | 91105 | — |
| University of California (UC) Davis Medical Center | Sacramento | California | 95817 | — |
| California Pacific Medical Center | San Francisco | California | 94115 | — |
| University of Colorado Denver - School of Medicine - Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| South Denver Gastroenterology | Englewood | Colorado | 80113 | — |
| Florida Research Institute | Lakewood Rch | Florida | 34211 | — |
| University of Miami - Schiff Center for Liver Diseases | Miami | Florida | 33136 | — |
| Gastro Health Research | Miami | Florida | 33176 | — |
| Covenant Metabolic Specialists, LLC | Sarasota | Florida | 33912 | — |
| Covenant Metabolic Specialists, LLC | Tampa | Florida | 33606 | — |
| Digestive Healthcare of Georgia | Atlanta | Georgia | 30309 | — |
| Northwestern Medicine Clinical Research Unit (CRU) | Chicago | Illinois | 60611 | — |
| Tulane University Medical Center | New Orleans | Louisiana | 70112 | — |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71105 | — |
| Mercy Medical Center - Baltimore, Maryland | Baltimore | Maryland | 21202 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Henry Ford Health System | Novi | Michigan | 48377 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Kansas City Research Institute | Kansas City | Missouri | 64131 | — |
| New-York-Presbyterian Brooklyn Methodist Hospital | Brooklyn | New York | 11215 | — |
| Northwell Health Center for Liver Disease and Transplantation | Manhasset | New York | 11030 | — |
| New York University (NYU) Langone Medical Center | New York | New York | 10016 | — |
| Weill Cornell Medicine | New York | New York | 10065 | — |
| University of Rochester Medical Center - Strong Memorial Hospital | Rochester | New York | 14642 | — |
| Gastro Health Research | Liberty Township | Ohio | 45044 | — |
| Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| UPMC Center for Liver Health | Pittsburgh | Pennsylvania | 15213 | — |
| OGI - Gastro One | Cordova | Tennessee | 38018 | — |
| Galen Hepatology | Hixson | Tennessee | 37343 | — |
| Gastrointestinal Associates of Northeast Tennessee, P.C. | Johnson City | Tennessee | 37604 | — |
| American Research Corporation - San Antonio, TX | Austin | Texas | 78757 | — |
| The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas | 75203 | — |
| Liver Center of Texas | Dallas | Texas | 75234 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Soma Clinical Trials, LLC | Denison | Texas | 75020 | — |
| Baylor College of Medicine - Baylor Clinic | Houston | Texas | 77030 | — |
| Liver Associates of Texas, P.A. | Houston | Texas | 77030 | — |
| Bon Secours Liver Institute of Hampton Roads | Richmond | Virginia | 23226 | — |
| Velocity Clinical Research - Seattle | Seattle | Washington | 98105 | — |
| Stanford University | Seattle | Washington | 98195 | — |
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 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06060665, 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 4, 2026 · Synced Nov 5, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06060665 live on ClinicalTrials.gov.