Last updated on March 2018

Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)

Brief description of study

An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)

Detailed Study Description


To evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 8 weeks of treatment


To evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 12 and 26 weeks of treatment

To evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 52 weeks of treatment

To evaluate the pharmacokinetics (PK) of MBX-8025


To evaluate the effect of MBX-8025 on bile acids, additional markers of inflammation and renal function

MBX-8025 doses of 1 mg and 15 mg may be evaluated if dose adjustment occurs

Clinical Study Identifier: NCT02955602

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Tarek Hassanein, MD

Southern California Research Center
Coronado, CA United States
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Christopher Bowlus, MD

University of California, Davis Medical Center
Sacramento, CA United States
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Cynthia Levy, MD

University of Miami - Center for Liver Diseases
Miami, FL United States
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Norman Gitlin, MD

Atlanta Gastroenterology Associates, LLC
Atlanta, GA United States
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Michael R Galambos, MD

Digestive Healthcare of Georgia
Atlanta, GA United States
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Paul Thuluvath, MD

Mercy Medical Center
Baltimore, MD United States
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Stuart C Gordon, MD

Henry Ford Health System
Novi, MI United States
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Brian Borg, MD

University of Mississippi Medical Center
Jackson, MS United States
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Bruce Bacon, MD

Saint Louis University, Gastroenterology & Hepatology
Saint Louis, MO United States
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David Bernstein, MD

Northwell Health - Center for Liver Disease and Transplantation
Manhasset, NY United States
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Carmen Stancia, MD

NYU Langone Medical Center
New York, NY United States
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Joseph Odin, MD

The Mount Sinai Medical Center
New York, NY United States
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Marlyn Mayo, MD

UT Southwestern Medical Center Investigation Drug Service
Dallas, TX United States
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John M Vierling, MD

Baylor College of Medicine
Houston, TX United States
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Stephen A Harrison, MD

Gastroenterology Consultants of SA
Live Oak, TX United States
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Mitchell Shiffman, MD

Bon Secours St. Mary's Immaculate Hospital
Newport News, VA United States
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Mark Swain, M.D.

University of Calgary Liver Unit
Calgary, AB Canada
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Hemant Shah, MD

Toronto Centre for Liver Disease
Toronto, ON Canada
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Yvonne Dorffel, MD

Outpatient Clinic of Internal Medicine
Berlin, Germany
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Andreas Kremer, MD

University Hospital Erlangen
Erlangen, Germany
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Peter Buggisch, MD

Ifi-Studien und Projekte GmbH, An der Asklepios Klinik St. Georg
Hamburg, Germany
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Michael Manns, MD

Center of Internal Medicine - Medical School of Hannover
Hannover, Germany
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Marcus Worns, MD

University Medical Centre of the Johannes Guttenberg-University
Mainz, Germany
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Christoph Berg, MD

Medizinische Universitatsklinik Tubingen
Tubingen, Germany
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Gideon Hirschfield, MD

University Hospitals Birmingham
Birmingham, United Kingdom
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George Mells, MD

Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
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Lynsey Corless, MD

Hull and East Yorkshire Hospitals NHS Trust
Hull, United Kingdom
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Douglas Thorburn, MD

Royal Free London NHS Foundation Trust
London, United Kingdom
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David Sheridan, MD

Plymouth Hospitals NHS Trust
Plymouth, United Kingdom
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Richard Aspinall, MD

Portsmouth Hospitals NHS Trust
Portsmouth, United Kingdom
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Sabine Hazan, MD

Ventura Clinical Trials
Ventura, CA United States
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Steven Flamm, MD

Northwestern University
Chicago, IL United States
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Charles Landis, MD

University of Washington
Seattle, WA United States
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Till Wissniowski, MD

Universitatsklinikum Giessen und Marburg GmbH
Marburg, Germany
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Aparna Goel, MD

Standford University Medicine
Palo Alto, CA United States
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Aparna Goel, MD

Stanford University
Stanford, CA United States
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