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

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.

Timeline

Start

2013-08

Primary completion

2014-07

Completion

2014-07

Outcome

Met primary endpoint

paper 45·3% in those given the 10 mg dose (p<0·0001). PMID 26047975 ↗

paper 10 mg dose by 179·0% (p<0·0001). PMID 26047975 ↗

Publications

• Martin SS, Ditmarsch M, Simmons M, Alp N, Turner T, Davidson MH, Kastelein JJP. Comparison of low-density lipoprotein cholesterol equations in patients with dyslipidaemia receiving cholesterol ester transfer protein inhibition. Eur Heart J Cardiovasc Pharmacother. 2023 Feb 2;9(2):148-155. doi: 10.1093/ehjcvp/pvac056.
• 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.
• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Atorvastatin	Small molecule	20 mg	—
Subject	Obicetrapib	Small molecule	1 mg	—
Subject	Obicetrapib	Small molecule	2.5 mg	—
Subject	Obicetrapib	Small molecule	5 mg	—
Subject	Obicetrapib	Small molecule	10 mg	—
Comparator	Rosuvastatin	Small molecule	10 mg	—

Indications