Researchers have discovered a promising new drug combination that significantly lowers “bad” LDL cholesterol for people whose levels remain stubbornly high, even after taking statins. The new pill pairs a novel drug called obicetrapib with an existing medication, ezetimibe.
In a recent Phase 3 clinical trial led by Cleveland Clinic researchers, the combination reduced LDL levels by nearly 49% in just three months. The findings were presented at the European Atherosclerosis Society meeting in Glasgow, Scotland, and were simultaneously published in The Lancet.
LDL cholesterol, often called “bad” cholesterol, is a major risk factor for heart disease. When levels are too high, fatty deposits can build up in blood vessels, increasing the risk of heart attacks and strokes.
Dr. Corey Bradley, a cardiologist at Columbia University, explained that managing high LDL levels remains a significant challenge for many people. “Many people have such a high LDL they will require multiple agents to control it,” Bradley said.
The clinical trial included 407 participants with an average age of 68. Despite taking cholesterol-lowering medications like statins, everyone in the study still had LDL levels above 70 mg/dL—levels considered risky by medical standards.
Researchers divided the participants into four groups: one group took the combo pill of obicetrapib and ezetimibe, two groups took each drug separately, and the last group took a placebo. All participants continued their usual cholesterol medications during the trial.
The lead researcher, Dr. Ashish Sarraju, a preventive cardiologist at the Cleveland Clinic, emphasized the importance of providing patients with more options for managing cholesterol.
“We need to give patients and their doctors all the options we can to try to get LDL under control if they are at risk for—or already have—cardiovascular disease,” Sarraju stated. He noted that in high-risk patients, lowering LDL as quickly and sustainably as possible is crucial for preventing heart-related problems.
High-risk patients typically include those who have already suffered a stroke or heart attack or are at high risk for these events. Even with the strongest statins available, some people struggle to bring their LDL levels down to safe ranges.
According to the American Heart Association (AHA), LDL levels should be kept under 100 mg/dL for the general population, and below 70 mg/dL for high-risk patients. For many, achieving these targets with statins alone is difficult, and additional treatments are necessary.
NewAmsterdam Pharma, the Dutch company that developed obicetrapib, is now planning to discuss potential approval of the drug combination with the U.S. Food and Drug Administration (FDA) later this year, according to a company spokesperson. If approved, it could become a vital option for those who have struggled to lower their cholesterol with existing medications.
However, there is some cautious optimism around the new drug. In the past, other drugs in the same class as obicetrapib have not always been successful. Some failed to prevent strokes or heart attacks, even if they managed to lower LDL levels.
Dr. Robert Rosenson of Mount Sinai Health System acknowledged these past challenges but expressed hope for obicetrapib. “But I am cautiously hopeful,” he said, suggesting that this new combination might succeed where others have not.
NewAmsterdam Pharma is already moving forward with additional trials to evaluate whether this drug combination can not only lower cholesterol but also prevent major heart events, like heart attacks and strokes. This next phase of research is crucial because simply lowering cholesterol is not enough—the real goal is to reduce life-threatening heart problems.
Lifestyle changes such as eating a healthy diet, exercising regularly, and avoiding smoking remain important for managing cholesterol. However, even with these lifestyle improvements, many people still struggle to reach safe LDL levels.
According to Dr. Bradley from Columbia University, only about 20% of patients successfully manage their LDL through lifestyle changes alone.
The findings from this new study could represent a significant step forward in the fight against heart disease. If future trials prove successful, obicetrapib combined with ezetimibe could provide a powerful new option for millions of people battling high cholesterol and heart disease.
As researchers continue to explore the benefits and risks of this new combination, many are hopeful that it could become a standard part of treatment for those most at risk.
If you care about heart health, please read studies about how eating eggs can help reduce heart disease risk, and Vitamin K2 could help reduce heart disease risk.
For more information about heart health, please see recent studies about how to remove plaques that cause heart attacks, and results showing a new way to prevent heart attacks, strokes.
The research findings can be found in The Lancet.
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