A new study from researchers at Mass General Brigham offers hope for people living with severely high triglyceride levels—a condition that can lead to life-threatening inflammation of the pancreas.
The experimental drug olezarsen has been shown to significantly lower triglyceride levels and reduce the risk of acute pancreatitis, according to findings presented at the American Heart Association Scientific Sessions and published in *The New England Journal of Medicine*.
Triglycerides are a type of fat that circulates in the bloodstream and provides energy to the body. However, when levels rise too high—a condition known as severe hypertriglyceridemia—they can trigger inflammation of the pancreas, called acute pancreatitis.
This painful condition can cause severe abdominal pain, organ failure, and even death. About one in every 100 people in the United States has severe hypertriglyceridemia, making it a serious public health concern.
The two new clinical trials, known as CORE-TIMI 72a and CORE2-TIMI 72b, tested olezarsen in patients with dangerously high triglyceride levels. These trials were led by the TIMI Study Group at Mass General Brigham in collaboration with Ionis Pharmaceuticals, the drug’s sponsor.
In total, 1,063 participants from 33 countries took part. All had fasting triglyceride levels above 500 mg/dL, even though many were already on lipid-lowering therapies like statins or fibrates.
Participants were randomly assigned to receive either monthly injections of olezarsen (at doses of 50 mg or 80 mg) or a placebo for one year.
The results were striking. More than 85% of people taking olezarsen saw their triglyceride levels fall below 500 mg/dL, compared with just 35% in the placebo group. This improvement means that most patients were brought out of the danger zone for pancreatitis.
Even more compelling were the results on acute pancreatitis itself. Across both trials, there were 29 reported cases of acute pancreatitis.
Among patients treated with olezarsen, the incidence was just 1.1 cases per 100 patient-years, compared to 6.2 per 100 patient-years in the placebo group. That translates to an 85% reduction in risk—a remarkable achievement for a condition that currently has limited treatment options.
“These findings support olezarsen’s potential to become a cornerstone therapy for severe hypertriglyceridemia, particularly for preventing a serious and potentially life-threatening condition,” said lead author Dr. Nicholas Marston, a cardiologist at the Mass General Brigham Heart and Vascular Institute.
“Prevention is key in medicine, and our findings underscore the importance of clinical trials in evaluating new treatments to improve health outcomes.”
Olezarsen works by targeting a specific gene that influences triglyceride production in the liver, effectively reducing the amount of fat circulating in the blood. By keeping triglyceride levels under control, the drug helps prevent the buildup of fat in the pancreas and other organs, which can trigger inflammation.
The treatment was well tolerated overall, and no major safety issues were reported during the year-long study. However, researchers emphasized the need for longer-term data to confirm its safety and effectiveness over time.
To address this, an open-label extension study is now underway, allowing patients from the original trials to continue treatment and monitoring outcomes over several years.
The discovery marks a major step forward in managing high triglyceride levels. Currently, lifestyle changes—such as dietary adjustments, exercise, and alcohol reduction—remain the first line of defense. But for patients whose triglyceride levels remain dangerously high despite these measures, new therapies like olezarsen could be lifesaving.
If future studies confirm its benefits, olezarsen could soon offer a powerful new option for millions at risk of pancreatitis and other complications of severe hypertriglyceridemia. As Dr. Marston concluded, “These findings bring us closer to preventing one of the most painful and dangerous conditions linked to high triglycerides.”
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The study is published in New England Journal of Medicine.
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