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The protocol was redirected by the FDA to another division and will be resubmitted at a future date.
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This is a randomized, double-blind, placebo-controlled parallel group study of HU6 and placebo in subjects who are overweight or obese with T2D.
The study will be conducted in 4 stages.
This is a randomized, double-blind, placebo-controlled parallel group study of HU6 and placebo in subjects who are overweight or obese with T2D.
The study will be conducted in 4 stages (Figure 1).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment HU6 | Experimental | Subjects who are randomized to active study drug will receive 450mg of HU6 for 14 day and then 600mg of HU6 for 168 days. N = 24 |
|
| Placebo | Placebo Comparator | Placebo Comparator is non-active study drug. N = 24 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HU6 | Drug | HU6 is being evaluated for its effect on Energy Metabolism, Muscle and Liver Substrate Metabolism, and Mitochondrial Function |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleeping Metabolic Rate (SMR) change from Baseline to 6 Months (26 weeks) | Change from baseline in SMR at 6 months (26 weeks) as assessed by whole room indirect calorimetry (WRIC). | 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Garner, PhD | Rivus Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth Translational Research Institute | Orlando | Florida | 32804 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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