Study to Evaluate the Effects of Two Doses of Seladelpar (MBX-8025) in Subjects With Primary Biliary Cirrhosis (PBC)
Public ClinicalTrials.gov record NCT02609048. 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 12-week, Double-blind, Randomized, Placebo-controlled, Phase 2 Study, to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC) and an Inadequate Response to Ursodeoxycholic Acid (UDCA)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to evaluate the effect of seladelpar (MBX-8025) on alkaline phosphatase (AP) levels in participants with primary biliary cirrhosis (PBC).
Study identification
- NCT ID
- NCT02609048
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 41 participants
Conditions and interventions
Conditions
Interventions
- Placebo Comparator Drug
- Experimental: Seladelpar 50 mg Drug
- Experimental: Seladelpar / MBX-8025 200 mg Drug
Drug
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
- Nov 4, 2015 (Actual)
- Primary completion
- Jul 1, 2016 (Actual)
- Completion
- Jul 1, 2016 (Actual)
- Last update posted
- Feb 25, 2025
2015 – 2016
United States locations
- U.S. sites
- 21
- U.S. states
- 12
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic of Arizona | Phoenix | Arizona | 85054 | — |
| University of California, Davis Medical Center | Sacramento | California | 95817 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| University of Miami, Center for Liver Diseases | Miami | Florida | 33136 | — |
| Norman Gitlin, MD | Atlanta | Georgia | 30308 | — |
| Digestive Helathcare of Georgia | Atlanta | Georgia | 30309 | — |
| Indiana University Hospital - Clinical Research Center | Indianapolis | Indiana | 46202 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Gastroenterology Associates of Western Michigan, PLC, d.b.a. West Michigan Clinical Research | Wyoming | Michigan | 49519 | — |
| Kansas City Gastroenterology and Hepatology | Kansas City | Missouri | 64131 | — |
| St. Louis University School of Medicine | St Louis | Missouri | 63110 | — |
| University of Nebraska Medical Center / The Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| North Shore-Long Island Jewish Health System / Division of Gastroenterology | Manhasset | New York | 11030 | — |
| NYU Langone Medical Center | New York | New York | 10016 | — |
| Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center | New York | New York | 10029 | — |
| Consultants for Clinical Research | Cincinnati | Ohio | 45249 | — |
| CHI St. Luke's Health Baylor College of Medicine Medical Center - Advanced Liver Therapies | Houston | Texas | 77030 | — |
| Pinnacle Clinical Research | Live Oak | Texas | 78233 | — |
| American Research Corporation at Texas Liver Institute | San Antonio | Texas | 78215 | — |
| Bon Secours St. Mary's Hospital of Richmond | Newport News | Virginia | 23602 | — |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | — |
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 28 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02609048, 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 Feb 25, 2025 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02609048 live on ClinicalTrials.gov.