Safety and Tolerability Study of SHP626 in Overweight and Obese Adults
Non-Alcoholic Steatohepatitis
About this trial
This is an interventional treatment trial for Non-Alcoholic Steatohepatitis
Eligibility 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.
Sites / Locations
- New Orleans Center for Clinical Research
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
SHP626
Placebo
9/12 subjects -1x daily dose of 20mg for 12 days 9/12 subjects-1x daily dose of 40mg for 12 days 9/12 subjects-1x daily dose of 80mg for 12 days 9/12 subjects-1x daily dose of 120mg for 12 days or dose lower than 80mg for 12 days 9/12 subjects-1x daily dose of 160mg for 12 days or dose lower than 80mg for 12 days 9/12 subjects-2x daily dose of SHP626 (dose TBD) for 12 days 9/12 subjects-2x daily dose of SHP626 (dose TBD; lower or higher than cohort 6) for 12 days 9/12 subjects-1x or 2x daily dose of SHP626 in an escalating titration (doses TBD). Initial 3 days of SHP626 followed by an increased dose of SHP626 for 3 days and finally a further increase in dose of SHP626 for 6 days 9/12 subjects will take a 1x or 2x daily dose of SHP626 in escalating titration (doses TBD; lower or higher dose than cohort 8). Initial 3 days of SHP626 followed by an increased dose of SHP626 for 3 days and finally a further increase in dose of SHP626 for 6 days
Three subjects per cohort will take a matched placebo