Phase 3 study · Ipsen · NCT07387549
Ipsen's phase 3 elafibranor study for primary sclerosing cholangitis
About 350 adults with large duct PSC are planned, and by chance each takes 1 elafibranor 120mg tablet or 1 placebo tablet once a day. Neither participants nor study doctors know which, and treatment continues until enough health events occur, which the listing expects to take about 5 years.
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These questions restate the study's public listing in plain words. Your answers stay on this device and are never sent. You can print a one-page summary to go over with your hepatologist.
1. Are you an adult between the ages of 18 and 75?
2. Has a doctor confirmed your primary sclerosing cholangitis (PSC) with blood tests and imaging?
The listing's summary says the study is for people with large duct PSC. Your hepatologist can tell you which type of PSC you have.3. Have you had a liver transplant, or been told your liver disease has decompensated or caused complications of cirrhosis?
4. Have you had a bile duct procedure in the last 60 days, or do you have a bile duct stent or drain now?
5. Have you ever had a bacterial bile duct infection (cholangitis), or taken antibiotics in the last 60 days to prevent that infection?
The listing does not say clearly whether an infection more than 60 days ago counts, so the study team decides.6. Have you ever had, or been suspected of having, bile duct cancer or liver cancer?
7. Have you ever taken elafibranor (Iqirvo), including in another study?
The study team also checks for these, which are easier to go over with your hepatologist:
- Another long-term liver disease, cirrhosis rated Child-Pugh B or C, or a condition such as Paget's disease that raises ALP outside the liver
- Norucholic acid, fibrates, seladelpar or glitazones in the 3 months before baseline
- Cyclosporine, mycophenolate, pentoxifylline, long-term steroids other than a steady dose for IBD, or some medicines that may harm the liver, in the 3 months before baseline
- A heart tracing (ECG) with a QTcF over 450msec in men or 470msec in women, significant kidney disease, or HIV
- Regularly drinking more than 2 standard drinks a day for men or 1 for women, or alcohol or other substance abuse in the past year
- Cancer in the past 5 years, except treated basal cell skin cancer or early cervical cancer (in situ), or pregnancy or breastfeeding
Sites and contact
US sites from the public ClinicalTrials.gov record, refreshed every hour. Only the study team decides who can join.
- Arizona Liver HealthChandler, Arizona · Recruiting
- Mayo Clinic in ArizonaPhoenix, Arizona · Not yet recruiting
- Southern California Research CenterCoronado, California · Recruiting
- University of California San DiegoLa Jolla, California · Not yet recruiting
- Keck Medicine of USC - USC Healthcare Center 1Los Angeles, California · Not yet recruiting
- Cedars-Sinai Medical CenterLos Angeles, California · Not yet recruiting
- California Liver Research InstitutePasadena, California · Recruiting
- Stanford UniversityRedwood City, California · Not yet recruiting
- University of California Davis Medical CenterSacramento, California · Not yet recruiting
- Sutter Health Van Ness Campus Medical Office BuildingSan Francisco, California · Not yet recruiting
- University of California, San Francisco Medical CenterSan Francisco, California · Recruiting
- University of Colorado Hospital Anschutz Outpatient PavilionAurora, Colorado · Not yet recruiting
- Peak Gastroenterology AssociatesColorado Springs, Colorado · Recruiting
- South Denver Gastroenterology,P.C.Englewood, Colorado · Recruiting
- Rocky Mountain Gastroenterology (RMG)Littleton, Colorado · Recruiting
- Yale Medical Group - Yale Digestive Diseases -Temple Medical Center LocationNew Haven, Connecticut · Not yet recruiting
- MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)Washington D.C., District of Columbia · Not yet recruiting
- University of Miami - Schiff Center for Liver DiseasesMiami, Florida · Recruiting
- Piedmont Hospital - Piedmont Transplant InstituteAtlanta, Georgia · Not yet recruiting
- Northwestern MedicineChicago, Illinois · Not yet recruiting
- Rush University Medical CenterChicago, Illinois · Not yet recruiting
- The University of Chicago MedicineChicago, Illinois · Not yet recruiting
- Indiana University School of MedicineIndianapolis, Indiana · Recruiting
- Gastroenterology Health Partners, PLLC (Southern Indiana Location)New Albany, Indiana · Not yet recruiting
- Deaconess GI Specialty CenterNewburgh, Indiana · Not yet recruiting
- The University of Iowa Hospitals & ClinicsIowa City, Iowa · Recruiting
- University Of Louisville School Of MedicineLouisville, Kentucky · Not yet recruiting
- Mercy Medical Center, IncBaltimore, Maryland · Recruiting
- Johns Hopkins University School of MedicineBaltimore, Maryland · Not yet recruiting
- Massachusetts General HospitalBoston, Massachusetts · Not yet recruiting
- Beth Israel Deaconess Medical CenterBoston, Massachusetts · Not yet recruiting
- University of MichiganAnn Arbor, Michigan · Not yet recruiting
- Henry Ford Health SystemDetroit, Michigan · Not yet recruiting
- Mayo Clinic Cancer Center (MCCC) - RochesterRochester, Minnesota · Not yet recruiting
- Saint Louis UniversitySt Louis, Missouri · Not yet recruiting
- University of Nebraska Medical CenterOmaha, Nebraska · Not yet recruiting
- NYU Langone Gastroenterology and Hepatology AssociatesNew York, New York · Not yet recruiting
- Weill Medical College Of Cornell UniversityNew York, New York · Not yet recruiting
- Mount Sinai Medical CenterNew York, New York · Not yet recruiting
- University of Rochester Medical CenterRochester, New York · Not yet recruiting
- Digestive Health Partners, PAAsheville, North Carolina · Not yet recruiting
- The University of North Carolina at Chapel HillChapel Hill, North Carolina · Not yet recruiting
- Carolinas Medical Center -Center for Liver Disease and Transplant-Kidney Transplant CentreCharlotte, North Carolina · Not yet recruiting
- Duke University Health SystemDurham, North Carolina · Not yet recruiting
- Dayton Gastroenterology- EnglewoodBeavercreek, Ohio · Not yet recruiting
- University Hospitals Cleveland Medical CenterCleveland, Ohio · Not yet recruiting
- Cleveland Clinic FoundationCleveland, Ohio · Not yet recruiting
- Penn State Milton S.Hershey Medical Center - Penn State Hershey Cancer InstituteHershey, Pennsylvania · Not yet recruiting
- University of Pennsylvania - Perelman Center for Advanced MedicinePhiladelphia, Pennsylvania · Not yet recruiting
- Thomas Jefferson University Hospital - Jefferson Digestive Disease Institute (JDDI)Philadelphia, Pennsylvania · Not yet recruiting
- University GastroenterologyProvidence, Rhode Island · Recruiting
- Medical University of South Carolina (MUSC)Charleston, South Carolina · Recruiting
- Rapid City Medical CenterRapid City, South Dakota · Not yet recruiting
- Gastro OneCordova, Tennessee · Recruiting
- Gastrointestinal Associates of Northeast TennesseeJohnson City, Tennessee · Recruiting
- Methodist Health Systems Clinical Research InstituteDallas, Texas · Recruiting
- University of Texas Southwestern Medical CenterDallas, Texas · Not yet recruiting
- Baylor College of Medicine - Advanced Liver TherapiesHouston, Texas · Not yet recruiting
- Houston Methodist HospitalHouston, Texas · Not yet recruiting
- Liver Associates of Texas, P.A.Houston, Texas · Recruiting
- American Research Corporation at The Texas Liver InstituteSan Antonio, Texas · Recruiting
- Starhope Liver Center, PA - Starhope Clinical Research, LLCSan Antonio, Texas · Recruiting
- Intermountain Medical CenterMurray, Utah · Not yet recruiting
- University of Virginia Medical CenterCharlottesville, Virginia · Recruiting
- Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of RichmondRichmond, Virginia · Not yet recruiting
- Virginia Commonwealth University Medical CenterRichmond, Virginia · Not yet recruiting
- Northwest Gastroenterology AssociatesBellevue, Washington · Not yet recruiting
- Velocity Clinical Research, SeattleSeattle, Washington · Recruiting
- University of Wisconsin Hospitals and ClinicsMadison, Wisconsin · Not yet recruiting
Every site's own contact and the full eligibility list are on the official ClinicalTrials.gov listing for NCT07387549.
Questions people ask about Ipsen's phase 3 elafibranor study
Is Ipsen's phase 3 elafibranor study enrolling now?
ClinicalTrials.gov lists it as recruiting, as of its last update there on 2026-10-23. Only the study team can confirm whether a particular site is still taking people.
Where are the US sites for Ipsen's phase 3 elafibranor study?
The listing names 69 US sites, in Arizona, California, Colorado, Connecticut, District of Columbia, Florida and 24 other states. The full list is in the sites section of this page.
Who can join Ipsen's phase 3 elafibranor study?
About 350 adults with large duct PSC are planned, and by chance each takes 1 elafibranor 120mg tablet or 1 placebo tablet once a day. The main listed requirements are in the pre-check on this page. Only the study team decides who can join.
How do I contact the Ipsen's phase 3 elafibranor study team?
The listing names this contact: Ipsen Clinical Study Enquiries, clinical.trials@ipsen.com. Each site may also list its own contact on ClinicalTrials.gov.
Is Trial Friend part of this study?
No. Trial Friend is independent of this study and its sponsor, Ipsen. This page restates the public listing in plain words, and nothing here is medical advice; talk with your hepatologist about whether a study is right for you.
From the public ClinicalTrials.gov record NCT07387549, last updated there 2026-10-23. Questions checked against the listing on November 10, 2026. Trial Friend is independent of this study and its sponsor, and is not a medical provider. Nothing here is medical advice; talk with your hepatologist about whether a study is right for you.