Safety and Tolerability Study of SHP626 in Overweight and Obese Adults
Status: | Completed |
---|---|
Conditions: | Obesity Weight Loss, Gastrointestinal |
Therapuetic Areas: | Endocrinology, Gastroenterology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 3/28/2019 |
Start Date: | January 19, 2015 |
End Date: | June 19, 2015 |
A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Assess the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Multiple Oral Doses of SHP626 in Overweight and Obese Adult Subjects
This study will investigate the safety and tolerability of daily dosing regimens of SHP626 in
overweight and obese adults.
overweight and obese adults.
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.
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