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ACTIVE NOT RECRUITING Phase 2

A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.

NCT05627362 · View on ClinicalTrials.gov ↗

Study Summary

This study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC). PSC is a rare disease of the liver that leads to injury and destruction of bile ducts. Damage to bile ducts leads to buildup of bile in the liver, which then causes further damage, and leads to disease progression. This study will compare elafibranor to a placebo, a dummy treatment. The main objective of the trial will be to study the safety and side effects of the study drug. The trial will also study the study drug's effects on blood tests and other tests related to PSC disease activity.

Interventions

  • DRUG Elafibranor 80 mg
  • DRUG Elafibranor 120 mg
  • DRUG Placebo Matched to Elafibranor 80 mg
  • DRUG Placebo Matched to Elafibranor 120 mg

Study Locations (20)

California

  • Om Research LLC — Lancaster
  • Cedars-Sinai Medical Center — Los Angeles
  • University of California, Davis — Sacramento
  • Sutter Health Van Ness Campus Medical Office Building — San Francisco

Colorado

  • Peak Gastroenterology Associates — Colorado Springs
  • South Denver Gastroenterology,P.C. — Englewood
  • Rocky Mountain Gastroenterology (RMG) — Littleton

Florida

  • Schiff Center for Liver Diseases - University of Miami — Miami
  • Covenant Research — Sarasota

Connecticut

  • Yale University School Of Medicine - Yale Center For Clinical Investigation — New Haven

Georgia

  • Piedmont Hospital - Piedmont Transplant Institute — Atlanta

Louisiana

  • Tandem Clinical Research GI — Marrero

Maryland

  • Mercy Medical Center — Baltimore

Massachusetts

  • Beth Israel Deaconess Medical Center, Liver Research Center — Boston

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2022-12-29
Est. Completion 2026-08-28
Phase Phase 2

Sponsor

Ipsen

205 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05627362

The ClinicalTrials.gov registry entry for NCT05627362 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 205 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Primary Sclerosing Cholangitis appearing as the primary indexed condition, and to 4 interventions — of which Elafibranor 80 mg is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05627362 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05627362 about?

NCT05627362 is a clinical study titled "A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.". This study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC). PSC is a rare disease of the liver that leads to injury and destruction of bile ducts. Damage to bile ducts leads to buildup of bile in the liver, which then causes further...

What is the current status of trial NCT05627362?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2022-12-29. Estimated completion is 2026-08-28.

What conditions does trial NCT05627362 study?

This clinical trial studies the following conditions: Primary Sclerosing Cholangitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05627362?

The interventions under investigation include: Elafibranor 80 mg (DRUG), Elafibranor 120 mg (DRUG), Placebo Matched to Elafibranor 80 mg (DRUG), Placebo Matched to Elafibranor 120 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05627362?

This trial is sponsored by Ipsen, which has 205 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05627362 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial