A multicentre, randomized, double-blind, parallel-group, placebo-controlled, dose-ranging study to evaluate the efficacy, safety and tolerability of once daily oral dosing of GW501516 (2.5 mg, 5 mg and 10 mg) over 12 weeks in subjects withprimary hypercholesterolemia on background statin therapy.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 192

Inclusion Criteria

1. Male or female subjects aged 18-70 years (inclusive at the time of Pre- Screening
Visit 1)
2. Subjects who are on stable, approved dose of Simvastatin (20, 40 or 80 mg) or
Atorvastatin (10, 20, 40 or 80 mg) for a minimum of 8 Weeks prior to the prescreening visit 1.
3. Subjects with stable LDL-C =100 mg/dl (2.59 mmol/L) and =160 mg/dL (4.14
mmol/L) at Visits 1 and 2
4. Females, to be eligible to enter and participate in this study must be:
• of non –child bearing potential ( i.e. physiologically incapable of becoming
pregnant (tubal ligation, documented hysterectomy), including any female who
is post-menopausal [> 1 year without menstrual period and FSH/estradiol
concentrations are consistent with postmenopausal state]. Other reasons for
amenorrhoea should also be excluded by the Investigator
5. Subject has given full written informed consent prior to any study-related procedures being performed.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Metabolic Disease including:
• Diagnosis of Type 1 or Type 2 diabetes mellitus, or FPG >126mg/dL(>7.0mmol/L)
• Uncorrected thyroid dysfunction
• Significant weight gain or loss within the past 3 months prior to Screening Visit 2.
2. History of recent clinically significant cardiovascular disease at Visit 2 including:
• CHD, CHF (NYHA Class II-IV), stroke, peripheral vascular disease.
• History or ECG evidence of prior myocardial infarction in the past 6 months.
• Current unstable angina or history of unstable angina in the past 6 months.
• Coronary revascularization including percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery
• Clinically significant arrhythmia or valve heart disease.
• Blood pressure > 160/100 mmHg or resting heart rate > 100 bpm.
• Has a QTc interval > 450 msec in males or females, QTcb or QTcf, machine or
manual overreads at Screening Visit 2.
• Clinically significant ECG abnormalities
3. History of significant co-morbid diseases [e.g., severe Chronic Obstructive
Pulmonary disease (COPD), chronic gastrointestinal disease, etc.]
4. TGs in excess of 400mg/dL (4.52 mmol/L) at Visits 1 or 2 (for permitted re-test
details see Section 3.1.3)
5. Subjects with cTnI > 0.35ng/ml
6. Serum creatinine at Visit 2 > 1.4 mg/dL (124µmol/L) for females, or > 1.5mg/dL
(133µmol/L) for males at Visit 2.
7. Clinically significant anaemia defined by haemoglobin concentration (<12.0g/dL or
120.0 g/L) for males or (<11.0g/dL or <110.0g/L) for females at Visit 2
8. Documented history of hepato-biliary disease including a history of, or positive
laboratory results for hepatitis at Screening Visit 2, and/or clinically significant hepatic enzyme elevation, including any one of the following enzymes greater than 2.5 times the upper limit of normal (ULN) value at Screening:ALT, AST, ALP, total or direct bilirubin > 1.5 x ULN at Screening, unless consistent with presumed or diagnosed Gilbert’s disease.
9. History of metabolic acidosis or rhabdomyolysis, or a history of myalgia, myositis or
myopathy after taking statins and/or fibrates.
10. Signs or symptoms of myositis and/or CPK =3xULN at Visit 2
11. Any subject who has been withdrawn from therapy due to AEs after taking a PPAR? or a PPARa/? dual agonist
12. Any subject who is taking medications that are contraindicated for use in the
atorvastatin and simvastatin label.
13. Any subject currently taking or who has taken any of the following medications as
assessed at Screening Visit 2.
• Lipid-lowering agents (with exception of simvastatin 20, 40 or 80 mg and
atorvastatin 10, 20, 40, or 80 mg) and drugs known to have substantial effect on
lipid metabolism including but not limited to fish oil and vitamins within 8 Weeks prior to pre-screening Visit 1
• All oral glucose-lowering agents and insulin
• Anti-obesity agents
• Warfarin and digoxin
• Oral or injectable corticosteroids
• Oral anti-coagulant (other than aspirin, clopidogrel and non-steroidal anti-inflammatory drugs [NSAIDs]) within 30 days prior to the pre-screening Visit 1
• Antiretroviral drugs
• St. John’s Wort
• Use of Thiazolidinedione ( TZDs )
• Any major change in diet, exercise habits or smoking status
• Methotrexate, cyclosporine or monoclonal antibodies for rheumatoid arthritis or psoriasis
• Atypical antipsychotics medications
• Monoamine oxidase inhibitors
• Any OTC or herbal medications, including but not limited to vitamins supplements, unless prepared to cease self-me

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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