A Study of the Safety, Tolerance and Assessment of HE3286 on Insulin Sensitivity and Hepatic Glucose Production

Study Overview
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Brief Summary
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The objectives of this study are to evaluate the safety and tolerance of 20 mg (10 mg BID) of HE3286 when administered orally over 28 days to obese insulin-resistant adult subjects and, to assess the activity of HE3286 on insulin sensitivity and hepatic glucose production in obese insulin-resistant adult subjects.

Detailed Description
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Hollis-Eden Pharmaceuticals, Inc. is developing a new class of therapeutics for the treatment of Type 2 diabetes mellitus (T2DM). The investigational drug, HE3286, is a synthetic analog of a naturally occurring hormone with a potentially new mechanism of action that may improve the current therapeutic options available to a T2DM patient. The glucose clamp is the gold standard for measurement of insulin sensitivity. Given the observed activity of HE3286 in reducing insulin resistance in both impaired glucose intolerant subjects and type 2 diabetic patients, it is necessary to evaluate the physiological site of action (i.e. liver vs. skeletal muscle) of HE3286 in order to further understand the mechanism of action and to design future clinical trials.

Official Title
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A Phase I, Open Label Study of the Safety, Tolerance and Assessment of HE3286 on Insulin Sensitivity and Hepatic Glucose Production When Administered Orally to Obese Insulin-Resistant Adult Subjects for 28 Days

Conditions
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Insulin Resistance

Intervention / Treatment
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* Drug: HE3286


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subject 18-65 years of age Body Mass Index (BMI) is at least 29 kg/m2 but no more than 35 kg/m2 for females and no more than 37 kg/m2 for males Subject has fasting blood glucose level of < 126 mg/dL at Screening Subject has a 2 hour postprandial (following 75 grams glucose administration) blood glucose of 140-200 mg/dL at Screening Subject has fasting plasma insulin >=10 μU/mL Exclusion Criteria: Subject has a history of clinically significant cardiovascular disease (including coronary artery disease), clinically significant hepatic, respiratory or renal abnormalities, clinically significant endocrine disorders (including history of diabetes); or clinically significant neurological or psychiatric condition; Subject has any clinically significant abnormalities in laboratory results at screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HE3286<br>HE3286 20 mg (10 mg BID) | Drug: HE3286<br>* HE3286 20 mg (10 mg BID) for 28 days<br>* Other names: TRIOLEX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerance of 20 mg (10 mg BID) of HE3286 when administered orally over 28 days to obese insulin-resistant adult subjects |  | Study duration and 1-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity of HE3286 on insulin sensitivity and hepatic glucose production in obese insulin-resistant adult subjects. |  | Study period (28-days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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phase I, safety, tolerance, insulin resistance, obese