Safety and Tolerability Study of SHP626 in Overweight and Obese Adults

• Status: Completed
• Trial end date: 2015-06-19
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate the safety and tolerability of daily dosing regimens of SHP626 in overweight and obese adults.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mirum Pharmaceuticals, Inc.; Shire
• Treatments: Volixibat

Criteria

Inclusion Criteria:

• Males that comply with any applicable contraceptive requirements or females of non-childbearing potential

• No history of active or chronic disease other than that allowed by study (hypertension, hyperlipidemia and GERD or heartburn)

• Has a body mass index of 25-35 kg/m2 with a body weight of greater than 140lbs (assessed at screening)

Exclusion Criteria:

• No history of alcohol or substance abuse, including use of tobacco

• No substantial changes in eating habits or exercise routine.