Clinical trial NCT01970215: TA-8995: Its Use in Patients With Mild Dyslipidaemia (TULIP)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemia
Lead sponsor: Xention Ltd
Sponsor class: INDUSTRY
First posted: 2013-10-28
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: The co-primary efficacy endpoints are the percentage changes in both HDL-C and LDL-C levels at Week 12 compared to baseline.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: H:S Amager Hospital
city: Esbjerg
country: Denmark
facility: Sydvestjysk Sygehus
city: Herlev
country: Denmark
facility: Herlev University Hospital
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Silkeborg
country: Denmark
facility: Regionshopitalet - Silkeborg
city: Almere
country: Netherlands
facility: EB FlevoResearch B.V
city: Amsterdam-Zuidoost
country: Netherlands
facility: Academic Medical Centre
city: Amsterdam
country: Netherlands
facility: Andromed Amsterdam
city: Amsterdam
country: Netherlands
facility: Andromed Leiden
city: Breda
country: Netherlands
facility: Andromed Breda B.V
city: Eindhoven
country: Netherlands
facility: Andromed Eindhoven
city: Groningen
country: Netherlands
facility: Andromed Noord B.V
city: Leiderdorp
country: Netherlands
facility: Andromed Zoetermeer
city: Rotterdam
country: Netherlands
facility: Andromed Rotterdam BV
city: Sliedrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Velp
country: Netherlands
facility: Andromed Oost
city: Zwijndrecht
country: Netherlands
facility: Praktijk Zwijndrecht
Study officials:
References:
citation: van Capelleveen JC, Kastelein JJ, Zwinderman AH, van Deventer SJ, Collins HL, Adelman SJ, Round P, Ford J, Rader DJ, Hovingh GK. Effects of the cholesteryl ester transfer protein inhibitor, TA-8995, on cholesterol efflux capacity and high-density lipoprotein particle subclasses. J Clin Lipidol. 2016 Sep-Oct;10(5):1137-1144.e3. doi: 10.1016/j.jacl.2016.06.006. Epub 2016 Jun 25.
citation: Hovingh GK, Kastelein JJ, van Deventer SJ, Round P, Ford J, Saleheen D, Rader DJ, Brewer HB, Barter PJ. Cholesterol ester transfer protein inhibition by TA-8995 in patients with mild dyslipidaemia (TULIP): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet. 2015 Aug 1;386(9992):452-60. doi: 10.1016/S0140-6736(15)60158-1. Epub 2015 Jun 2.