The multicenter, Phase II, nationwide clinical trial involved 285 participants, including patients at UC San Diego Health, and was done in collaboration with the Cleveland Clinic Coordinating Center for Clinical Research.
Researchers at University of California San Diego School of Medicine identified a potential new treatment, an investigational drug called lorundrostat, for individuals with uncontrolled or treatment-resistant hypertension, commonly known as high blood pressure.
The study, published in the April 23, 2025 online edition of the New England Journal of Medicine, found that clinical trial participants taking the new drug experienced a 15-point reduction in systolic blood pressure, the top number in a blood pressure reading, compared to a 7-point reduction for patients who received 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 multicenter, Phase II, nationwide clinical trial involved 285 participants, including patients at UC San Diego Health, and was done in collaboration with the Cleveland Clinic Coordinating Center for Clinical Research.
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.”
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.
Co-authors of the study include Luke Laffin, Steven Nissen, Carrie Melgaard, Kathy Wolski, Ashish Sarraju, all at Cleveland Clinic; Branko Kopjar, Reena Mehra, University of Washington; Jessica Ibbitson, Shivani Bhikam, David Rodman, Mineralys Therapeutics; Matthew Weir, University of Maryland; Elizabeth Ofili, Morehouse School of Medicine; James Luther, Vanderbilt University Medical Center; Debbie Cohen, University of Pennsylvania; and John Flack, Southern Illinois University.
The study was funded by Mineralys Therapeutics (NCT05769608).
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