--- title: "Obicetrapib: The Oral CETP Pill That Lowers Both LDL and Lp(a) - BROADWAY, TANDEM, and a CHMP Green Light (August 10, 2026) | PepTracker Pro Blog" url: https://peptrackerpro.com/blog/obicetrapib-newamsterdam-menarini-cetp-inhibitor-oral-ldl-lp-a-lipoprotein-a-apob-broadway-tandem-brooklyn-prevail-ubeslo-evlarco-ezetimibe-chmp-august-10-2026 description: "CETP inhibitors were left for dead after torcetrapib raised blood pressure and killed patients. Obicetrapib revived the class - not by raising HDL, but by lowering LDL cholesterol by about a third and lipoprotein(a) by ~33% in a single once-daily oral pill. Here's what the Phase 3 BROADWAY and TANDEM trials showed, why its July 2026 EMA CHMP green light matters, and how the PREVAIL outcomes trial will decide its fate." lang: en --- Skip to main content **Educational information only.** This site does not provide medical advice. Read full disclaimer (https://peptrackerpro.com/disclaimer) Research & Compounds Research & Compounds # Obicetrapib: The Oral CETP Pill That Lowers Both LDL and Lp(a) - BROADWAY, TANDEM, and a CHMP Green Light (August 10, 2026) PepTracker Pro Research Team August 10, 2026 7 min read ## Table of Contents - A dead class comes back to life - What obicetrapib is - How it works - What BROADWAY showed - What TANDEM added - Where it fits: LDL and Lp(a) in one pill - Regulatory status: a CHMP green light - The trial that decides everything: PREVAIL - The bottom line ## A dead class comes back to life For twenty years, cholesteryl ester transfer protein - CETP - looked like one of cardiology's great dead ends. The idea was simple and appealing: CETP moves cholesterol out of protective HDL and into harmful LDL-like particles, so blocking it should raise 'good' cholesterol and cut heart disease. Then the drugs arrived and failed, one after another. Torcetrapib (Pfizer) actually raised blood pressure and killed more patients than placebo in the ILLUMINATE trial. Dalcetrapib, evacetrapib and anacetrapib were all abandoned for weak or absent benefit. The 'raise HDL' hypothesis collapsed. Obicetrapib is the drug that brought the class back - not by reviving the old idea, but by reframing what CETP inhibition is actually good for: lowering LDL cholesterol and lipoprotein(a). ## What obicetrapib is Obicetrapib (previously TA-8995 and AMG 899, and branded in Europe as Ubeslo on its own and Evlarco when combined with ezetimibe) is an investigational once-daily oral, highly selective CETP inhibitor. It is developed by NewAmsterdam Pharma - founded by lipid experts John Kastelein and Michael Davidson, who acquired the molecule from Amgen - with Menarini Group as the European commercial partner. It is a small-molecule pill, not a peptide, siRNA or antisense drug, and it is taken as a 10 mg tablet once a day, usually added on top of maximally tolerated statins (and often ezetimibe) in people who still have not reached their LDL goal. ## How it works CETP is a plasma protein that ferries cholesteryl esters out of HDL particles and hands them to LDL and other apolipoprotein B (apoB)-containing particles. By selectively blocking CETP, obicetrapib lowers LDL cholesterol, non-HDL cholesterol and apoB, raises HDL cholesterol, and - the part that has drawn the most attention - reduces lipoprotein(a) [Lp(a)] by roughly a third. Crucially, researchers no longer believe the HDL rise is what matters. The modern rationale is that obicetrapib lowers two independent, causal drivers of atherosclerosis, LDL and Lp(a), in a single oral pill. That is what separates it from the first-generation CETP inhibitors that chased HDL and failed. ## What BROADWAY showed BROADWAY, the pivotal Phase 3 trial, randomized 2,530 adults with atherosclerotic cardiovascular disease (89%) or heterozygous familial hypercholesterolemia (17%), nearly all already on statins, to obicetrapib 10 mg once daily or placebo for one year. At day 84, LDL cholesterol fell by 29.9% with obicetrapib versus a 2.7% rise with placebo - a placebo-adjusted reduction of roughly a third that held through the full year. Lp(a) dropped by 33.5% versus placebo. Cardiovascular events were numerically lower on obicetrapib (4.2% vs 5.2%; hazard ratio 0.79, 95% CI 0.54-1.15), but BROADWAY was not powered for outcomes, so that signal is only hypothesis-generating. The drug was well tolerated, with no blood-pressure signal of the kind that doomed torcetrapib. BROADWAY was published in the New England Journal of Medicine in 2025. ## What TANDEM added TANDEM tested a fixed-dose combination pill of obicetrapib 10 mg plus ezetimibe 10 mg against obicetrapib alone, ezetimibe alone and placebo in 407 adults over 84 days. The combination lowered LDL cholesterol by 48.6% versus placebo - about half - and by 16.8% more than obicetrapib alone, while obicetrapib monotherapy cut LDL by 31.9%. Serious adverse events were low and comparable across groups. TANDEM, published in The Lancet in 2025 and presented alongside BROADWAY at the European Atherosclerosis Society Congress, reflects a broader shift toward starting combination lipid therapy early rather than titrating one drug at a time. An earlier trial, BROOKLYN, had already shown marked LDL lowering in heterozygous familial hypercholesterolemia, a genetically hard-to-treat group. ## Where it fits: LDL and Lp(a) in one pill Obicetrapib's niche is the person who has both stubbornly high LDL and moderately elevated Lp(a). The dedicated Lp(a) therapies - the siRNAs olpasiran, lepodisiran and zerlasiran, the antisense drug pelacarsen, and the oral small molecule muvalaplin - lower Lp(a) far more dramatically (60-95%), but they are aimed at very high Lp(a) levels and most are injections. Many people have Lp(a) that is elevated enough to matter but not high enough to qualify for those trials, and they may prefer a pill. Obicetrapib offers a modest ~33% Lp(a) reduction bundled with a substantial LDL cut in one accessible oral tablet - and it sits alongside another oral newcomer, the PCSK9 inhibitor enlicitide, in the emerging category of pills that go beyond statins. ## Regulatory status: a CHMP green light On July 24, 2026, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorization for Ubeslo (obicetrapib monotherapy) and Evlarco (obicetrapib plus ezetimibe) for primary hypercholesterolemia and mixed dyslipidemia. A final European Commission decision is expected in the second half of 2026, with UK MHRA and Swiss Swissmedic decisions also anticipated in that window. That makes obicetrapib one step from becoming the first CETP inhibitor ever approved - but as of this writing it is not yet approved anywhere, and it remains an investigational, prescription clinical-stage medicine rather than a supplement or research chemical. ## The trial that decides everything: PREVAIL Lowering LDL and Lp(a) on paper is not the same as preventing heart attacks, and that is what the Phase 3 PREVAIL cardiovascular outcomes trial exists to prove. PREVAIL randomized roughly 9,541 adults with established atherosclerotic cardiovascular disease to obicetrapib 10 mg or placebo on top of standard-of-care lipid therapy, with a primary endpoint of major adverse cardiovascular events - cardiovascular death, heart attack, stroke and coronary revascularization. Enrollment finished in April 2024 and results are expected in 2026. A positive PREVAIL would validate both obicetrapib and the reborn CETP class; a neutral one would leave it, like anacetrapib before it, a drug that moves the numbers without clearly moving outcomes. ## The bottom line Obicetrapib is a once-daily oral CETP inhibitor that revived a class most experts had written off. It lowers LDL cholesterol by about a third on its own and roughly half when paired with ezetimibe, and it cuts lipoprotein(a) by around 33% - all in a well-tolerated pill, with pivotal data in the New England Journal of Medicine and The Lancet and a positive EMA CHMP opinion in July 2026. Its promise is an accessible oral option for people with high LDL and moderately raised Lp(a) who are underserved by statins alone and not candidates for injectable Lp(a) drugs. Its open question is the one every lipid drug must answer: the PREVAIL outcomes trial, reporting in 2026, will show whether lower numbers become fewer events. Obicetrapib is investigational and not a supplement; nothing here is medical advice. Ready to track your peptide research? Open PepTracker Pro (https://app.peptrackerpro.com/) PepTracker Pro Research Team The PepTracker Pro Research Team is an editorial group of science writers, pharmacologists, and clinical researchers dedicated to making peptide science accessible. Every article is reviewed for accuracy against peer-reviewed sources and updated as new evidence emerges. ## Citations 1. [1] Nicholls SJ, et al. - Safety and Efficacy of Obicetrapib in Patients at High Cardiovascular Risk (BROADWAY, Phase 3), New England Journal of Medicine (2025) Source (https://www.nejm.org/doi/full/10.1056/NEJMoa2415820) 2. [2] Sarraju A, et al. - Fixed-dose combination of obicetrapib and ezetimibe for LDL cholesterol reduction (TANDEM, Phase 3), The Lancet (2025) Source (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00721-4/abstract) 3. [3] NewAmsterdam Pharma and Menarini Group Receive Positive CHMP Opinion for Ubeslo and Evlarco (obicetrapib) - July 24, 2026 Source (https://www.globenewswire.com/news-release/2026/07/24/3332807/0/en/NewAmsterdam-Pharma-and-Menarini-Group-Receive-Positive-CHMP-Opinion-Recommending-Marketing-Authorization-for-Ubeslo-Obicetrapib-Monotherapy-and-Evlarco-Obicetrapib-Plus-Ezetimibe-.html) 4. [4] NewAmsterdam Pharma Doses First Patient in PREVAIL Cardiovascular Outcomes Trial of Obicetrapib Source (https://ir.newamsterdampharma.com/news-releases/news-release-details/newamsterdam-pharma-doses-first-patient-prevail-cardiovascular) 5. [5] Back From the Brink: Obicetrapib Performs Well in BROADWAY, TANDEM - TCTMD (2025) Source (https://www.tctmd.com/news/back-brink-obicetrapib-performs-well-broadway-tandem) **Disclaimer:** This article is for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare provider. 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