Outcomes trials first (the four that will decide the field), then the phase 2 and 3 studies behind them. Facts from ClinicalTrials.gov and the publications; dates are the registry's, checked at each build. See also the agents and the timeline.
| Trial | Agent | N | Status | Registry |
|---|---|---|---|---|
| PREVAIL | Obicetrapib | 9,541 | Active, not recruiting; primary completion November 2026 | NCT05202509 |
| REVEAL | Anacetrapib | 30,449 | Completed 2017; positive, drug discontinued anyway | NCT01252953 |
| ACCELERATE | Evacetrapib | 12,092 | Terminated for futility, 2015 | NCT01687998 |
| dal-OUTCOMES | Dalcetrapib | 15,871 | Completed 2012; neutral | NCT00658515 |
| dal-GenE | Dalcetrapib | 6,147 | Completed 2021 | NCT02525939 |
| ILLUMINATE | Torcetrapib | 15,067 | Terminated December 2006 for excess mortality | NCT00134264 |
| Menarini European phase 3 (NCT07614958) | Obicetrapib | Recruiting; primary completion January 2027 | NCT07614958 | |
| Obicetrapib CCTA imaging trial | Obicetrapib | 300 | Active, not recruiting; primary completion November 2027 | NCT06305559 |
| TANDEM | Obicetrapib | 407 | Completed September 2024 | NCT06005597 |
| DalCor genotype-defined trial (NCT05918861) | Dalcetrapib | Recruiting; primary completion August 2027 | NCT05918861 | |
| BROOKLYN | Obicetrapib | 354 | Completed May 2024 | NCT05425745 |
| BROADWAY | Obicetrapib | 2,530 | Completed September 2024 | NCT05142722 |
Active, not recruiting; primary completion November 2026
The cardiovascular outcomes trial the whole class has been waiting for: 9,541 patients at high risk, randomised to obicetrapib 10 mg daily or placebo on top of maximally tolerated lipid-lowering therapy. Started February 2022, primary completion November 2026. If PREVAIL is positive, CETP inhibition becomes a therapy; if it is neutral, the class is finished as a preventive strategy whatever the LDL-C numbers say.
Completed 2017; positive, drug discontinued anyway
The largest CETP trial ever run: 30,449 patients with atherosclerotic vascular disease, all on intensive atorvastatin, randomised to anacetrapib 100 mg daily or placebo, primary completion January 2017. It met its primary endpoint, the only CETP inhibitor ever to do so. Merck discontinued development regardless.
Terminated for futility, 2015
12,092 patients with high-risk vascular disease randomised to evacetrapib or placebo, stopped early for futility. HDL-C more than doubled, LDL-C fell, and the event curves stayed together. The trial that ended the simple HDL hypothesis.
Completed 2012; neutral
15,871 patients randomised after a recent acute coronary syndrome to dalcetrapib or placebo. HDL-C rose by about a third, apoB barely moved, and there was no effect on cardiovascular outcomes. The first large trial to show that raising HDL-C with a CETP agent does not translate into benefit.
Completed 2021
6,147 patients selected for the ADCY9 genotype that a dal-OUTCOMES pharmacogenomic analysis suggested marked responders, randomised to dalcetrapib or placebo after an acute coronary syndrome. The first prospective test of a genotype-first hypothesis in this class.
Terminated December 2006 for excess mortality
15,067 patients randomised to torcetrapib plus atorvastatin or atorvastatin alone, halted in December 2006 for excess mortality and cardiovascular events in the torcetrapib arm. The single most consequential trial in the history of the class.
Recruiting; primary completion January 2027
A 426-patient phase 3 study started May 2026 by Menarini, obicetrapib's European partner, with primary completion January 2027. Part of the European launch programme rather than the pivotal file.
Active, not recruiting; primary completion November 2027
300 patients imaged by coronary CT angiography to measure the effect of obicetrapib with ezetimibe on plaque, primary completion November 2027. The mechanistic companion to the outcomes programme.
Completed September 2024
407 patients randomised to the obicetrapib and ezetimibe fixed-dose combination or its components, completed September 2024. The trial behind Evlarco, the combination product in the European filing.
Recruiting; primary completion August 2027
A further phase 3 trial of dalcetrapib in a genetically defined population, n=2,000, started October 2023 with primary completion in August 2027. The live continuation of the ADCY9 story, and the reason it is wrong to say the CETP field consists of obicetrapib alone.
Completed May 2024
354 patients with heterozygous familial hypercholesterolaemia on top of maximally tolerated therapy, randomised to obicetrapib or placebo, completed May 2024. The HeFH arm of the phase 3 programme.
Completed September 2024
2,530 patients on maximally tolerated lipid-lowering therapy randomised to obicetrapib 10 mg or placebo. The largest of the three phase 3 LDL-C trials behind the European filing, completed September 2024.