TA-8995: Its Use in Patients With Mild Dyslipidaemia (TULIP)

A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study of TA-8995 in Patients With Mild Dyslipidaemia, Alone and In Combination With Statin Therapy

The primary objective of this study is to evaluate the efficacy of different doses of TA-8995, a cholesteryl ester transfer protein (CETP) inhibitor, on the elevation of high-density lipoprotein cholesterol (HDL-C) and reduction of low-density lipoprotein cholesterol (LDL-C), alone and in combination with statin therapy.

The secondary objectives of this study are to determine the safety and tolerability of TA-8995 in patients with mild dyslipidaemia.

Inclusion Criteria:

• Fasting LDL-C levels >2.5 mmol/L and <4.5 mmol/L, HDL-C levels <1.8 mmol/L and >0.8 mmol/L, and TG levels <4.5 mmol/L after run in or washout of existing therapies
• Not on lipid-altering therapy at screening or on lipid-altering treatment regimens at screening

Exclusion Criteria:

• Body mass index >32 kg/m2;
• Participation in another clinical study involving an investigational or marketed drug within 30 days prior to enrolment (Visit 2);
• Any clinical manifestation of atherosclerotic vascular disease;
• Diagnosis of type 1 diabetes;
• Uncontrolled type 2 diabetes: haemoglobin A1c >8%;
• Uncontrolled hypertension: sitting systolic blood pressure >160 mmHg and/or sitting diastolic blood pressure >90 mmHg;
• History of hyperaldosteronism;
• Active muscle disease or persistent creatine kinase concentration >3 × the upper limit of normal (ULN). One retest will be allowed after 1 week to verify the result;