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A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid

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Trial Profile

A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 08 May 2025

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At a glance

  • Drugs Bezafibrate/obeticholic acid (Primary) ; Bezafibrate; Obeticholic acid
  • Indications Primary biliary cirrhosis
  • Focus Therapeutic Use
  • Sponsors Intercept Pharmaceuticals

Most Recent Events

  • 30 Apr 2025 According to Intercept Pharmaceuticals media release, company announced oral presentations of data from a Phase 2 study evaluating the combination of obeticholic acid and bezafibrate in PBC, and investigational data for INT-787, a next-generation FXR agonist. The conference will be held in San Diego on Saturday, May 3, 9:15 AM ET. The conference will be held from May 3-6 in San Diego.
  • 04 Nov 2024 Planned End Date changed from 1 Dec 2025 to 1 Oct 2025.
  • 05 Jun 2024 According to Intercept Pharmaceuticals media release,company announced new data from a planned six-month analysis data of this trial at the European Association for the Study of the Liver (EASL) Congress 2024 being held June 5-8, 2024, in Milan, Italy.

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