The objectives of this study are to evaluate the safety, tolerance and pharmacokinetics of HE3286 when administered daily for 28 days to obese adult subjects and to assess potential activity of HE3286 to decrease insulin resistance. An open-label cohort of 6 patients with type II diabetes mellitus will be treated at 10 mg (5 mg BID).
HE3286 has a potentially new mechanism of action that may improve the current therapeutic options available to patients with metabolic disorders, inflammatory and autoimmune diseases. In preclinical experiments, HE3286 has shown to have anti-inflammatory activity associated with corticosteroids but without the side effects known with corticosteroid use, such as immune suppression and bone loss. HE3286 has demonstrated glucose-lowering and insulin-enhancing effects in several preclinical mouse and rat models of insulin resistance. In these experiments, HE3286 lowered blood glucose levels and prevented progression of hyperglycemia and HE3286 appeared to enhance insulin sensitivity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
66
Dose escalating cohort driven study. 6 planned cohorts. 1. HE3286 5 mg or placebo QD for 28 days; 2. HE3286 10 mg (5 mg BID) or placebo BID for 28 days 3. HE3286 20 mg (10 mg BID) or placebo BID for 28 days 4. HE3286 40 mg (20 mg BID) or placebo BID for 28 days 5. HE3286 4 mg (2 mg BID), 20 mg (10 mg BID) or placebo BID for 28 days 6. HE3286 10mg (5 mg BID) for 28 days (open-label cohort in patients with T2DM)
Unnamed facility
Baton Rouge, Louisiana, United States
dgd Research, Inc.
San Antonio, Texas, United States
safety and pharmacokinetics
Time frame: Duration of the study
To assess the potential activity of HE3286 to decrease insulin resistance
Time frame: duration of study
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