Scientists have discovered a promising new therapy for resistant high blood pressure, leading to a 15-point drop in systolic levels.
Researchers at the University of California, San Diego School of Medicine have identified a potential new treatment for individuals with uncontrolled or treatment-resistant hypertension, a condition commonly referred to as high blood pressure. The investigational drug, lorundrostat, showed encouraging results in a recent clinical trial.
Published in the New England Journal of Medicine, the study found that participants who received lorundrostat experienced an average 15-point reduction in systolic blood pressure, the upper number in a blood pressure reading, compared to a 7-point reduction in those given a placebo.
“This study was designed to look at the impact of a novel medication in lowering blood pressure for individuals whose hypertension is inadequately controlled by current standard medications,” said Michael Wilkinson, MD, principal investigator for the study at UC San Diego School of Medicine and cardiologist at UC San Diego Health.
The findings stem from a Phase II, multicenter clinical trial conducted across the United States. The trial enrolled 285 participants, including patients from UC San Diego Health, and was carried out in collaboration with the Cleveland Clinic Coordinating Center for Clinical Research.
The Scope and Impact of Hypertension
According to the U.S. Centers for Disease Control and Prevention, hypertension affects approximately 120 million people across the United States, nearly half of all adults, and is considered the leading cause of heart disease in the country. Usually, high blood pressure has no signs or symptoms.
The hormone aldosterone plays a crucial role in regulating the body’s blood pressure, and when it is dysregulated, it can contribute to hypertension.
“We were specifically studying a new approach to addressing imbalanced aldosterone, which is an often underrecognized cause for treatment-resistant hypertension,” said Wilkinson.
Over the course of 12 weeks, all participants in the trial received a standardized antihypertensive medication. Additionally, 190 received a measured amount of the trial drug, which stops production of the hormone aldosterone, while 95 received a placebo.
“All participants used the same standardized medications for their blood pressure for the first three weeks of the trial before beginning the drug or placebo, which allowed us the opportunity for a baseline and to truly understand the effectiveness of the treatment,” said Wilkinson, associate professor of medicine at UC San Diego School of Medicine. “Ultimately, we found that the therapy, compared to placebo, was helpful in lowering a person’s systolic blood pressure.”
Significant Reductions in Systolic Pressure Observed
Each participant’s blood pressure was monitored continuously for 24 hours at the beginning, middle, and end of the trial. For the individuals who received the medication, their systolic blood pressure levels dropped, on average, around 15 millimeters of mercury (mmHg).
“While blood pressure readings remained elevated at the end of this Phase II trial in some participants treated with lorundrostat, we find these results promising because almost all participants involved in the study were not able to sufficiently lower their blood pressure with medication before,” said Wilkinson. “As we learn more about the safety and efficacy of this treatment, I’m hopeful we will identify a useful tool in addressing high blood pressure for patients in need.”
Wilkinson also noted that the clinical trial included a more diverse patient population, which could lead to a more adequate treatment for high blood pressure in a wider range of individuals at an increased risk of heart disease. Next steps for the research involve a larger, Phase III trial of the medication.
Reference: “Lorundrostat Efficacy and Safety in Patients with Uncontrolled Hypertension” by Luke J. Laffin, Branko Kopjar, Carrie Melgaard, Kathy Wolski, Jessica Ibbitson, Shivani Bhikam, Matthew R. Weir, Elizabeth O. Ofili, Reena Mehra, James M. Luther, Debbie L. Cohen, Ashish Sarraju, Michael J. Wilkinson, John M. Flack, David Rodman and Steven E. Nissen, 22 April 2025, New England Journal of Medicine.
DOI: 10.1056/NEJMoa2501440
The study was funded by Mineralys Therapeutics (NCT05769608).
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