Efficacy of LCQ908 on Cardiovascular Risk

This study had 2 parts. Part A was a multicenter, double-blind, randomized,
placebo-controlled, non-confirmatory crossover study assessing response to a high-fat meal
challenge in the setting of pradigastat versus placebo. Part A had 2 cohorts i.e. Cohort 1
patients with stable coronary artery disease and hypertriglyceridemia and Cohort 2 patients
with asymptomatic non-obstructive coronary artery disease or elevated coronary heart disease
risk and hypertriglyceridemia.

Part B was a double blinded phase designed to assess response to three months of chronic
treatment with pradigastat versus placebo on a normal diet.

The trial was terminated after the interim analysis of Part A, Cohort 1. The interim
analysis results indicated that the high-fat meal challenge did not induce any impairment on
either myocardial perfusion reserve index (MPRi) or exercise treadmill performance. Part B
was never started.

Inclusion Criteria:

- History of coronary artery disease

- Elevated triglycerides

- On medication to help lower cholesterol

Exclusion Criteria:

- Poorly controlled diabetic patients and/or change in diabetic medication within 12
weeks of screening

- History of myocardial infarction (heart attack) within 6 months of screening

- History of a procedure to open a blocked coronary artery within 12 months of
enrollment

- History of Coronary Artery Bypass Graft (CABG) surgery

- History of congestive heart failure

- History of significant heart valve disease