Dyslipidemia
Conditions
Brief summary
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.
Interventions
Sponsors
Xention Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The co-primary efficacy endpoints are the percentage changes in both HDL-C and LDL-C levels at Week 12 compared to baseline. | 12 weeks |
Countries
Denmark, Netherlands
Outcome results
None listed