The Effects of RVX000222 on Glucose Metabolism in Individuals With Pre-diabetes

Inclusion criteria

• Males aged 18-70 years, inclusive
• Body mass index (BMI): 25-40 kg/m2
• HDL cholesterol plasma levels: ≤1.4 mmol/L
• Pre-diabetes: Either impaired fasting glucose (IFG; 6.1-6.9mmol/L) or impaired glucose tolerance (IGT; 2 hour OGTT glucose 7.8-11.0mmol/L, WHO classification) as measured at Visit 1
• No current use or need for prescription or over-the-counter medication within four days of Visit 1
• Have given signed informed consent to participate in the study

Exclusion criteria

• Identification of any other medical condition requiring immediate therapeutic intervention
• Has received any over-the-counter medication including vitamins, herbal, or dietary supplements within four days of Visit 1 unless prior approval from the Investigator
• Tobacco use within six months of Visit 1 (including cigarettes, pipes, chewing tobacco)
• Elective surgery requiring general anaesthesia during the course of the study
• Clinically significant heart disease at Visit 1
• Clinically significant abnormal ECG at Visit 1
• Evidence of renal impairment defined as serum creatinine >1.5 mg/dL (133 μmol/L) or creatinine clearance of <60 mL/min
• History of hypertension or supine SBP >160mmHg or DBP >95mmHg as measured at Visit 1
• Evidence of type 2 diabetes (fasting plasma glucose ≥7.0mmol/L; 2 hour OGTT glucose ≥11.1mmol/L)
• Evidence of liver disease defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT) or total bilirubin >1.5 x upper limit of normal (ULN) at Visit 1
• History of malignancy within past 5 years
• History or evidence of drug or alcohol abuse within 12 months of Visit 1
• Use of other investigational drugs and/or devices at the time of enrolment, or within 30 days of Visit 1
• History of non-compliance to medical regimens or unwillingness to comply with the study protocol
• Any condition that in the opinion of the Investigators would confound the evaluation and interpretation of the data
• Persons directly involved in the execution of the protocol