A Phase 2, Randomized, Double Blind, Placebo Controlled Clinical Study Investigating the Effects of Obeticholic Acid and Atorvastatin Treatment on Lipoprotein Metabolism in Subjects With Nonalcoholic Steatohepatitis.

Trial Profile

A Phase 2, Randomized, Double Blind, Placebo Controlled Clinical Study Investigating the Effects of Obeticholic Acid and Atorvastatin Treatment on Lipoprotein Metabolism in Subjects With Nonalcoholic Steatohepatitis.

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 31 Jul 2017

At a glance

  • Drugs Obeticholic acid (Primary) ; Atorvastatin
  • Indications Non-alcoholic steatohepatitis
  • Focus Therapeutic Use
  • Acronyms CONTROL
  • Sponsors Intercept Pharmaceuticals
  • Most Recent Events

    • 31 Jul 2017 Results published in an Intercept Pharmaceuticals media release.
    • 31 Jul 2017 Primary endpoint (The effect of Obeticholic Acid on low-density lipoprotein (LDL) metabolism in subjects with biopsy confirmed nonalcoholic steatohepatitis (NASH) and the ability of atorvastatin to modulate this effect using the measures below) has been met according to an Intercept Pharmaceuticals media release.
    • 09 Jan 2017 Planned primary completion date changed from 1 Dec 2016 to 1 Mar 2017.
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