A Randomized, Blinded, Placebo-controlled, Phase 1 Study to Assess the Relative Potency of Multiple Oral Doses of LUM001 and SHP626 in Overweight and Obese Adult Subjects, as Assessed by Fecal Bile Acid Excretion

Trial Profile

A Randomized, Blinded, Placebo-controlled, Phase 1 Study to Assess the Relative Potency of Multiple Oral Doses of LUM001 and SHP626 in Overweight and Obese Adult Subjects, as Assessed by Fecal Bile Acid Excretion

Completed
Phase of Trial: Phase I

Latest Information Update: 29 Mar 2016

At a glance

  • Drugs Lopixibat chloride (Primary) ; Volixibat (Primary)
  • Indications Alagille syndrome; Cholestasis; Intrahepatic cholestasis; Non-alcoholic steatohepatitis; Primary biliary cirrhosis; Primary sclerosing cholangitis
  • Focus Therapeutic Use
  • Sponsors Shire
  • Most Recent Events

    • 18 Mar 2016 Status changed from recruiting to completed, according to ClinicalTrials.gov record.
    • 27 Oct 2015 Planned number of patients changed from 48 to 84as per ClinicalTrials.gov record.
    • 27 Oct 2015 Planned End Date changed from 1 Jul 2015 to 1 Dec 2015 as per ClinicalTrials.gov record.
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