NCT02475317

Study to Assess the Relative Potency of Multiple Oral Doses of LUM001 and SHP626 in Overweight and Obese Adults as Assessed by Fecal Bile Acid Excretion

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Mirum Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the relative potency of multiple oral doses of LUM001 and SHP626 administered for 7 days as assessed by fecal bile acid excretion in overweight and obese adult subjects. This study is designed to address the relative potency question for the first time in the same.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Placebo	Participants will receive placebo matched to maralixibat/volixibat orally for 7 days.
DRUG	Maralixibat	Participants will receive maralixibat in 10 mg, 20 mg, 50 mg or 100 mg doses.
DRUG	Volixibat	Participants will receive volixibat in 10 mg and 20 mg doses.

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-06-18
• Last updated: 2019-04-04

Locations

1 site across 1 country: United States