Status:
COMPLETED
Safety and Tolerability Study of SHP626 in Overweight and Obese Adults
Lead Sponsor:
Mirum Pharmaceuticals, Inc.
Conditions:
Non-Alcoholic Steatohepatitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study will investigate the safety and tolerability of daily dosing regimens of SHP626 in overweight and obese adults.
Eligibility Criteria
Inclusion
- 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
- No history of alcohol or substance abuse, including use of tobacco
- No substantial changes in eating habits or exercise routine.
Key Trial Info
Start Date :
January 19 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2015
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT02287779
Start Date
January 19 2015
End Date
June 19 2015
Last Update
March 26 2019
Active Locations (1)
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1
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States, 37920