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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Dyslipidemia

Intervention / Treatment
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* Drug: TA-8995
* Drug: Atorvastatin
* Drug: Rosuvastatin
* Drug: TA-8995 0mg (placebo)
* Drug: Placebo Statin


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1<br>TA-8995 0mg (placebo) & placebo statin | Drug: TA-8995 0mg (placebo)<br> <br> Drug: Placebo Statin<br> <br> |
| Experimental: Group 2<br>TA-8995 1mg & placebo statin | Drug: TA-8995<br> <br> Drug: Placebo Statin<br> <br> |
| Experimental: Group 3<br>TA-8995 2.5mg & placebo statin | Drug: TA-8995<br> <br> Drug: Placebo Statin<br> <br> |
| Experimental: Group 4<br>TA-8995 5mg & placebo statin | Drug: TA-8995<br> <br> Drug: Placebo Statin<br> <br> |
| Experimental: Group 5<br>TA-8995 10mg & placebo statin | Drug: TA-8995<br> <br> Drug: Placebo Statin<br> <br> |
| Active Comparator: Group 6<br>TA-8995 0mg (placebo) & atorvastatin 20mg | Drug: Atorvastatin<br> <br> Drug: TA-8995 0mg (placebo)<br> <br> |
| Active Comparator: Group 7<br>TA-8995 10mg & atorvastatin 20mg | Drug: TA-8995<br> <br> Drug: Atorvastatin<br> <br> |
| Active Comparator: Group 8<br>TA-8995 0mg (placebo) & rosuvastatin 10mg | Drug: Rosuvastatin<br> <br> Drug: TA-8995 0mg (placebo)<br> <br> |
| Active Comparator: Group 9<br>TA-8995 10mg & rosuvastatin 10mg | Drug: TA-8995<br> <br> Drug: Rosuvastatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |