Patients With Primary Biliary Cholangitis(PBC) (GLYPP)

June 1, 2026 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Metabolic Surveillance During PPAR-Agonist Treatment in Primary Biliary Cholangitis: New Perspectives for an Integrated Disease Management Approach.

Primary Biliary Cholangitis (PBC) is a chronic autoimmune cholestatic liver disease characterized by the progressive destruction of small intrahepatic bile ducts, leading to chronic cholestasis, hepatic fibrosis, and, in advanced stages, cirrhosis. Recent advances in the understanding of PBC pathophysiology have highlighted the central role of immune, inflammatory, and metabolic alterations in disease onset and progression.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

The study will enroll patients with Primary Biliary Cholangitis (PBC) for whom treatment with PPAR agonists has been prescribed in routine clinical practice, either as first-line or second-line therapy according to current clinical indications.

The study procedures include:

  • Collection of demographic, clinical, laboratory, and treatment-related data. All information will be retrospectively and prospectively collected from patients' medical records and routinely available clinical documentation.
  • Collection of additional peripheral blood samples (10 mL) at baseline (T0) and after 3 months of therapy (T3). Blood sampling will be performed concurrently with routine blood draws already scheduled as part of standard clinical monitoring and follow-up of PBC patients, without requiring additional clinical visits or invasive procedures beyond standard care.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario A. Gemelli IRCCS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

PBC patients initiating PPAR-agonist therapy in first or second line as part of routine clinical care.

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Confirmed diagnosis of PBC (biochemical criteria, antibody positivity and/or histological examination)
  • The patient is a candidate for first- or second-line PPAR agonist therapy, as clinical practice, for the treatment of PBC
  • The patient requires comprehensive metabolic monitoring, as per clinical practice
  • Signed the informed consent form

Exclusion Criteria:

  • Patients with a prior diagnosis of diabetes mellitus currently on insulin therapy
  • Patients on treatment known to significantly affect glycemic values (e.g., GLP-1 receptor agonists, SGLT2 inhibitors, systemic corticosteroids)
  • Patients with a life expectancy or estimated time to liver transplantation of less than 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to 3 months in glycated hemoglobin (HbA1c) levels (%)
Time Frame: 3-16 months
Assessment of change in glycated hemoglobin (HbA1c) levels from baseline to 3 months in adult patients with Primary Biliary Cholangitis (PBC) treated with PPAR agonists in routine clinical practice.
3-16 months
Change from baseline to 3 months in fasting plasma glucose levels (mg/dL)
Time Frame: 3-16 months
Assessment of change in fasting plasma glucose levels from baseline to 3 months in adult patients with Primary Biliary Cholangitis (PBC) treated with PPAR agonists in routine clinical practice.
3-16 months
Change from baseline to 3 months in continuous glucose monitoring-derived time in range (%)
Time Frame: 3-16 months
Assessment of change in percentage of time in glucose range (70-180 mg/dL) derived from continuous glucose monitoring between baseline and 3 months in adult patients with Primary Biliary Cholangitis (PBC) treated with PPAR agonists in routine clinical practice.
3-16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Francesca Romana Ponziani, Fondazione Policlinico Universitario Agostino Gemelli,IRCCS,Roma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

May 18, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27454

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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