Study of Atorvastatin/Fenofibrate (LCP-AtorFen) Combination Therapy in Dyslipidemia

This is a multicenter, randomized, double-blind, 12 week study with a 52-week open-label
follow-up to evaluate the safety and efficacy of LCP-AtorFen (the combination of atorvastatin
and fenofibrate) in the treatment of hyperlipidemia.

After a wash-out phase, eligible patients will be randomized on a 1:1:1 ratio to either
LCP-AtorFen, atorvastatin or fenofibrate for 12 weeks. After the completion of the 12-week
phase, all eligible patients will be offered to receive open-label LCP-AtorFen for another 52
weeks.

Inclusion Criteria:

1. A diagnosis of dyslipidemia (non-HDL-C >130 mg/dL and Triglycerides > or equal to 150
mg/dL and < or equal to 500 mg/dL).

2. Subject may be currently on a statin or other lipid-lowering therapy but must be
willing and able to washout for 8 weeks if on a fibrate or high-dose niacin, 6 weeks
if on a statin or low-dose niacin per day, or 4 weeks if on a bile acid sequestrant,
ezetimibe, or >1000 mg of fish oil per day.

3. Other inclusion criteria might apply

Exclusion Criteria:

1. TGs > 500 mg/dL.

2. History of coronary heart disease (CHD), transient ischemic attacks, stroke or
revascularization procedure in the six months prior.

3. Presence of an aortic aneurysm or resection of an aortic aneurysm within six months.

4. Poorly controlled diabetes mellitus (glycosylated hemoglobin >8.0% )or diabetes
mellitus requiring insulin therapy.

5. Known lipoprotein lipase impairment or deficiency or Apo C-II deficiency or familial
dysbetalipoproteinemia.

6. History of pancreatitis.

7. Known allergy or sensitivity to statins or fibrates.

8. Poorly controlled hypertension.

9. Other exclusion criteria might apply.