ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

A 52-week, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Safety and Efficacy of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)

The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.

Study Overview

• Status: Completed
• Conditions: Primary Biliary Cholangitis
• Intervention / Treatment: Drug: seladelpar 5-10 mg; Drug: seladelpar 10 mg; Drug: Placebo

Detailed Description

Primary:

• To evaluate the safety and effect on cholestasis of two seladelpar regimens (5 mg/day titrated to 10 mg/day and 10 mg/day) over 52 weeks of treatment compared to placebo

Key Secondary:

• To evaluate the effect of seladelpar on normalization of alkaline phosphatase (AP) levels
• To evaluate the effect of seladelpar on pruritus

• Study Type: Interventional
• Enrollment (Actual): 265
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ramos Mejía, Argentina, B1704ETD
    • DIM Clinica Privada
  • Buenos Aires
    • Pilar, Buenos Aires, Argentina, B1629AHJ
      • Hospital Universitario Austral
  • Ciudad Autónoma De BuenosAires
    • Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina, C1180AAX
      • Fundacion Sanatorio Güemes
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000KDS
      • Hospital Provincial del Centenario
• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • The Canberra Hospital
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane & Women's Hospital
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • St Vincents Hospital Melbourne
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital
  • Western Australia
    • Perth, Western Australia, Australia, 6000
      • Royal Perth Hospital
• Austria
  • Graz, Austria, 8036
    • LKH-Universitätsklinikum Klinikum Graz
  • Salzburg, Austria, 5020
    • Salzburger Landeskliniken
  • Wels, Austria, 4600
    • Klinikum Wels-Grieskirchen GmbH
  • Wien
    • Vienna, Wien, Austria, A-1090
      • Medizinische Universitat Wien
• Belgium
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • UZ Antwerpen
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • UZ Gent
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • UZ Leuven
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary Medicine
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • University of Manitoba
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network
    • Vaughan, Ontario, Canada, M3N 2V7
      • Toronto Digestive Disease Associates Inc
  • Quebec
    • Montréal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre (MUHC)
• Chile
  • La Serena, Chile, 1720506
    • Centro Clinico Mediterraneo
  • Viña Del Mar, Chile, 2540364
    • Centro de Investigaciones Clinicas Viña del Mar
  • Región-MetropolitanadeSantiago
    • Santiago, Región-MetropolitanadeSantiago, Chile, 8330034
      • Pontificia Universidad Catolica de Chile
• France
  • Bondy, France, 93140
    • Hôpital Jean Verdier
  • Grenoble, France, 38043
    • CHU de Grenoble
  • Paris, France, 75012
    • Hopital Saint Antoine
• Germany
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Berlin
  • Erlangen, Germany, 91054
    • Universitatsklinikum Erlangen
  • Hamburg, Germany, 20246
    • ifi-Institute for Interdisciplinary Medicine
  • Leipzig, Germany, 04103
    • Universitätsklinikum Leipzig
  • Baden-Württemberg
    • Tübingen, Baden-Württemberg, Germany, 72076
      • Universitatsklinikum Tubingen
  • Nordrhein-Westfalen
    • Herne, Nordrhein-Westfalen, Germany, 44623
      • Gastroenterologische Gemeinschaftspraxis Herne
    • Köln, Nordrhein-Westfalen, Germany, 50937
      • Uniklinik Koln
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24146
      • Gastroenterologisch Hepatologisches Zentrum Kiel
• Greece
  • Heraklion, Greece, 71110
    • University General Hospital of Heraklion
  • Larissa, Greece, 41110
    • University General Hospital of Larissa
  • Patras, Greece, 26504
    • University General Hospital of Patras
• Hungary
  • Budapest, Hungary, 1111
    • Budai Hepatológiai Centrum
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Kaposvár, Hungary, 7400
    • Somogy Megyei Kaposi Mor Oktato Korhaz
  • Csongrád
    • Szeged, Csongrád, Hungary, 6720
      • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
• Israel
  • Hadera, Israel, 38100
    • Hillel Yaffe Medical Center
  • Haifa, Israel, 31096
    • Rambam Health Corporation
  • Haifa, Israel, 31048
    • Carmel Medical Center
  • Jerusalem, Israel, 91120
    • Hadassah Medical Center
  • Nahariya, Israel, 22100
    • The Galilli Medical Center
  • Ramat Gan, Israel, 52662
    • Chaim Sheba Medical Center
  • Reẖovot, Israel, 76100
    • Kaplan Medical Center
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center
• Italy
  • Firenze, Italy, 50134
    • Azienda Ospedaliera Universitaria Careggi
  • Milano, Italy, 20142
    • ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
  • Modena, Italy, 41126
    • Ospedale Civile di Baggiovara
  • Padova, Italy, 35128
    • Azienda Ospedaliera di Padova
  • Rozzano, Italy, 20090
    • ASST di Monza - Azienda Ospedaliera San Gerardo
• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Pusan National University Hospital
  • Daegu, Korea, Republic of, 700-721
    • Kyungpook National University Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 06273
    • Gangnam Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of
    • Severance Hospital Yonsei University Health System
  • Seoul, Korea, Republic of, 03722
    • Inje University Ilsan Paik Hospital
  • Seoul, Korea, Republic of, 137 701
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Gyeonggido
    • Seongnam-si, Gyeonggido, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
• Mexico
  • Ciudad de Mexico, Mexico, 06700
    • Consultorio Medico - Distrito Federal
  • Metepec, Mexico, 52140
    • Consultorio de la Doctora Maria Sarai Gonzalez Huezo
  • Hidalgo
    • Pachuca de Soto, Hidalgo, Mexico, 42086
      • Centro de Diabetes y Obesidad Graber
• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Radboud Universitair Medisch Centrum
• New Zealand
  • Hamilton, New Zealand, 3240
    • Waikato Hospital
  • South Island
    • Christchurch, South Island, New Zealand, 8011
      • Christchurch Hospital
    • Dunedin, South Island, New Zealand, 9001
      • Dunedin Hospital
• Poland
  • Kielce, Poland, 25-317
    • Wojewodzki Szpital Zespolony w Kielcach
  • Kraków, Poland, 31-531
    • SP ZOZ Szpital Uniwersytecki w Krakowie
  • Mysłowice, Poland, 41-400
    • ID Clinic
  • Kujawsko-pomorskie
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-030
      • Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-781
      • Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
  • Slaskie
    • Katowice, Slaskie, Poland, 40-752
      • Samodzielny Publiczny Szpital Kliniczny nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach
• Romania
  • Bucharest, Romania, 022328
    • Fundeni Clinical Institute
  • Bucharest, Romania, 020125
    • Colentina Clinical Hospital
  • Bucharest, Romania
    • Sana Monitoring SRL
  • Timis
    • Timişoara, Timis, Romania, 300723
      • Pius Brinzeu Emergency Clinical County Hospital
• Russian Federation
  • St. Petersburg, Russian Federation, 197110
    • City Hospital #31
  • Ulyanovsk, Russian Federation, 432063
    • Ulyanovsk Regional Clinical Hospital
  • Moskva
    • Moscow, Moskva, Russian Federation, 117198
      • Peoples Friendship University of Russia
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Hospital Centar Zvezdara
  • Belgrade, Serbia, 11080
    • KBC Zemun
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron - PPDS
  • Barcelona, Spain
    • Hospital Universitario Germans Trias i Pujol
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Málaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe de Valencia
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro - Majadahonda
• United Kingdom
  • Birmingham, United Kingdom, B15 2TT
    • University Hospital Birmingham
  • Hull, United Kingdom, HU3 2JZ
    • Hull and East Yorkshire Hospitals NHS Trust
  • London, United Kingdom, NW3 2QG
    • Royal Free London NHS Foundation Trust
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital
  • London, United Kingdom, E1 1BB
    • Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre
  • Newcastle, United Kingdom, NE7 7DN
    • The Newcastle Upon Tyne Hospital NHS Foundation Trust
  • Nottingham, United Kingdom, NG7 2UH
    • University of Nottingham
  • Plymouth, United Kingdom, PL6 8DH
    • Plymouth Hospitals NHS Trust
  • Swansea, United Kingdom, SA2 8QA
    • Singleton Hospital
  • Hampshire
    • Portsmouth, Hampshire, United Kingdom, PO6 3LY
      • Queen Alexandra Hospital
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Institute for Liver Health
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Arizona - PPDS
    • Tucson, Arizona, United States, 85711
      • The Institute for Liver Health-Tucson
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • Redwood City, California, United States, 94063
      • Stanford University School of Medicine
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center
    • San Francisco, California, United States, 94115
      • California Pacific Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Univeristy of Colorado Denver and Hospital
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale School of Medicine Digestive Diseases, Internal Medicine
  • Florida
    • Boca Raton, Florida, United States, 33434
      • Excel Medical Clinical Trials, LLC
    • Lakewood Ranch, Florida, United States, 34211
      • Florida Reserach Institute
    • Miami, Florida, United States, 33136
      • Schiff Center for Liver Diseases University of Miami
    • Tampa, Florida, United States, 33606
      • Tampa General Medical Group
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Digestive Healthcare of Georgia
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Indianapolis Gastroenterology Research Foundation
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University School of Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02114
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Novi, Michigan, United States, 48377
      • Henry Ford Health System
  • Minnesota
    • Maplewood, Minnesota, United States, 55117
      • Minnesota Gastroenterlogy, P.A.
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center, Fairview
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Southern Therapy and Advance Research (STAR) LLC
    • Tupelo, Mississippi, United States, 38801
      • Digestive Health Specialists PA
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • Kansas City Research Institute
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10016
      • NYU Langone Health
    • New York, New York, United States, 10016
      • Concorde Medical Group
    • New York, New York, United States, 10032
      • Center for Liver Disease and Transplantation
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Asheville Gastroenterology Associates, a Division of Digestive Health Partners, P.A.
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • UH Cleveland Medical Center
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Northeast Clinical Research Center, LLC
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S Hershey Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Gastro One
    • Knoxville, Tennessee, United States, 37909
      • GIA Clinical Trials, LLC
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • Dallas, Texas, United States, 75203
      • Liver Institute at Methodist Dallas
    • Fort Worth, Texas, United States, 76104
      • Texas Digestive Disease Consultants
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77030
      • American Research Corporation
    • San Antonio, Texas, United States, 78229
      • Pinnacle Clinical Research
    • San Antonio, Texas, United States, 78215
      • American Research Corporation at Texas Liver Institute
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
  • Virginia
    • Newport News, Virginia, United States, 23602
      • Mary Immaculate Hospital
    • Richmond, Virginia, United States, 23226
      • Bon Secours Richmond Community Hospital
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Must have given written informed consent (signed and dated) and any authorizations required by local law
2. 18 to 75 years old (inclusive)

3. Male or female with a diagnosis of PBC, by at least two of the following criteria:

   • History of AP above ULN for at least six months
   • Positive anti-mitochondrial antibody (AMA) titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay [ELISA]) or positive PBC-specific antinuclear antibodies
   • Documented liver biopsy result consistent with PBC
4. On a stable and recommended dose of UDCA for the past twelve months OR intolerant to UDCA (last dose of UDCA > 3 months prior to Screening)
5. AP ≥ 1.67 × ULN
6. Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose

Exclusion Criteria:

1. Previous exposure to seladelpar (MBX-8025)
2. A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer)
3. AST above 3 × ULN
4. ALT above 3 × ULN
5. Total bilirubin above 2.0 × ULN
6. Advanced PBC as defined by the Rotterdam criteria (albumin below LLN AND total bilirubin above 1 × ULN)
7. Creatine kinase (CK) above 1.0 × ULN
8. eGFR below 60 mL/min/1.73 m2 (calculated by MDRD formula)
9. International normalized ratio (INR) above 1.0 × ULN
10. Platelet count below 100 × 103/µL

11. Presence of clinically significant hepatic decompensation, including:

    • History of liver transplantation, current placement on liver transplantation list, or current MELD score ≥ 15
    • Complications of portal hypertension, including known esophageal varices, history of variceal bleeds or related interventions (e.g., transjugular intrahepatic portosystemic shunt placement), relevant ascites, hepatic encephalopathy
    • Cirrhosis with complications, including history or presence of spontaneous bacterial peritonitis

12. Other chronic liver diseases:

    • Current features of auto-immune hepatitis as determined by the investigator based on immunoserology, liver biochemistry and histology
    • Primary sclerosing cholangitis determined by presence of diagnostic cholangiographic findings
    • History or clinical evidence of alcoholic liver disease
    • History or clinical evidence of alpha-1-antitrypsin deficiency
    • Biopsy confirmed nonalcoholic steatohepatitis
    • History or evidence of Gilbert' Syndrome with elevated total bilirubin
    • History or evidence of hemochromatosis
    • Hepatitis B defined as presence of hepatitis B surface antigen (HBsAg)
    • Hepatitis C defined as presence of HCV RNA
13. Known history of HIV
14. Evidence of significant alcohol consumption
15. Evidence of drug abuse
16. Subjects with inadequate response to obeticholic acid (OCA) or intolerance to OCA: OCA must be discontinued 30 days prior to Screening
17. Use of colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids (> 2 weeks) within two months prior to Screening
18. Use of fibrates within 30 days prior to Screening
19. Use of simvastatin within 7 days prior to Screening
20. Use of an experimental or unapproved treatment for PBC within 30 days prior to Screening
21. Use of experimental or unapproved immunosuppressant within 30 days prior to Screening
22. Treatment with any other investigational therapy or device within 30 days or within five half-lives, whatever is longer, prior to Screening
23. For females, pregnancy or breast-feeding
24. Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; One capsule daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety study. Subjects on placebo will be re-randomized to initiate seladelpar at 5 or 10 mg once daily
Experimental: Seladelpar 10 mg	Drug: seladelpar 10 mg; Seladelpar 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label safety study. Subjects will continue the seladelpar dose (10 mg) received during the double-blinded study
Experimental: Seladelpar 5-10 mg	Drug: seladelpar 5-10 mg; Seladelpar 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety study. Subjects will continue the seladelpar dose (5 or 10 mg) received during the double-blinded study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Response to Composite Endpoint of ALP <1.67 × Upper Limit of Normal [ULN], ≥15% Reduction in ALP, and Total Bilirubin ≤ ULN) at Month 3	Percentage of Participants with Response to Composite Endpoint of ALP <1.67 × Upper Limit of Normal [ULN], ≥15% reduction in ALP, and total bilirubin ≤ ULN) at Month 3. The mITT analysis set included all randomized subjects who received at least one study drug dose. The primary endpoint was analyzed using Cochran-Mantel-Haenszel (CMH) test adjusted for both randomization stratification variables (ALP level: <350 U/L and 2:350 U/L; pruritus NRS: <4 and 2:4). The CMH tests were performed for the comparison of 10 mg versus placebo and 5 mg/10 mg versus placebo separately.	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Response Defined by Normalized Alkaline Phosphatase Levels at Month 3	The response was defined by normalized ALP levels (ALP ≤1.0 × ULN) at endpoint. The mITT analysis set included all randomized subjects who received at least one study drug dose.	Month 3
Change From Baseline in Pruritus NRS for Subjects With Baseline NRS ≥4 at Month 3	Pruritus Numerical Rating Scale (NRS) used to rate the intensity of the worst itching you experienced in the past 24 hours from no itching to worst possible itching by selecting a number from 0 to 10 on Itch Scale. Zero means no itching and 10 means worst imaginable itching. The analysis will be limited to those subjects in the mITT analysis set with a baseline NRS ≥ 4.	Month 3

Collaborators and Investigators

• Sponsor: CymaBay Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): February 16, 2020
• Study Completion (Actual): February 16, 2020

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: PBC; Primary Biliary Cholangitis (PBC)
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Cholangitis; Liver Cirrhosis, Biliary; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Seladelpar
• Other Study ID Numbers: CB8025-31735

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No