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
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
- 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.