Primary Outcome Measures:
- Changes in Insulin Sensitivity Measured by Peripheral and Adipose Tissue [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Changes in insulin sensitivity measured by peripheral and adipose tissue over 24 weeks
Secondary Outcome Measures:
- Degree of Macrophage Infiltration in Subcutaneous Adipose Tissue [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Evaluate degree of macrophage infiltration in subcutaneous adipose tissue over 24 weeks of treatment
- Expression of Chemokine Receptors Types 2 (CCR2) and 5 (CCR5) in Subcutaneous Adipose Tissue [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Evaluate expression of chemokine receptors types 2 (CCR2) and 5 (CCR5) in subcutaneous adipose tissue
- Changes from Baseline in Peripheral Monocyte Subsets (CD14/CD16) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Evaluate changes from baseline in peripheral monocyte subsets (CD14/CD16)
- Changes in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Evaluate changes in non-invasive imaging by multiparametric magnetic resonance imaging (MRI) for liver disease (LiverMultiScan™)
- Correlation of Non-invasive Liver Imaging Findings with Histology Results [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Evaluate correlation of non-invasive liver imaging findings with histology results
- Changes from Baseline in Liver Transaminases [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]Evaluate changes from baseline in liver transaminases
- Changes from Baseline in Serum Biomarker Panel [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Evaluate changes from baseline in serum biomarker panel
- Changes from Baseline in Metabolic Parameters [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Evaluate changes from baseline in metabolic parameters
- Number and Percentage of Subjects with Adverse Events over 24 Weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]Evaluation of adverse events over 24 weeks of treatment
- Changes from Baseline in Physical Examination over 24 Weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]Evaluation of physical examination
- Changes from Baseline in Vital Signs over 24 Weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]Evaluation of vital signs
- Changes from Baseline in 12 Lead ECG over 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]Evaluation of 12 lead ECG
- Pharmacokinetics (PK) of CVC in a population PK analysis [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Evaluate PK of CVC
