Safety and Tolerability Study of SHP626 in Overweight and Obese Adults

Mirum Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Non-Alcoholic Steatohepatitis

Treatments: Drug: SHP626; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02287779

SHP626-101

Details and patient eligibility

About

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

Enrollment: 84 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups, including a placebo group

SHP626

Experimental group

Description:

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

Treatment:

Drug: SHP626

Placebo

Placebo Comparator group

Description:

Three subjects per cohort will take a matched placebo

Treatment:

Drug: Placebo