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OpenTrials
Active, Not Recruiting

NCT Number: NCT07629128

Patients With Primary Biliary Cholangitis(PBC)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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. 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.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: GLYPP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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