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Study finds single dose of zilebesiran safely and effectively lowers blood pressure for six months

Compared to participants who received the placebo, participants who received single doses of zilebesiran had greater than 10 mm Hg reductions, on average, in 24-hour systolic blood pressure and greater than 90% reductions in serum levels of AGT, a hormone produced predominantly in the liver that contributes to blood pressure regulation.
At the three-month follow-up, the participants in groups that received the 300 mg and 600 mg doses of zilebesiran had 24-hour average systolic blood pressure that was lowered by 15 mm Hg or more on average.
After six months, people receiving zilebesiran were significantly more likely to experience 24-hour average systolic blood pressure reductions of 20 mm Hg or more on average without taking additional high blood pressure medications.
People receiving zilebesiran were more likely to achieve 24-hour average systolic blood pressure measurements of 130 mm Hg or less at six months.

394 patients were randomized, and 377 patients were ultimately included in the analysis: 302 were randomized to one of the four zilebesiran dosage groups and 75 people to the placebo group. Their average age was 57 years old.
About 25% of participants were Black adults; 56% were men.
The study was conducted at sites in Canada, Ukraine, the United Kingdom and the U.S., and 78% of participants lived in the U.S. Due to challenges with data collection with the war in the Ukraine, data from the 16 patients randomized in Ukraine were excluded from the analyses.
Average blood pressure of participants at time of enrollment in the study was 141.8/81.8 mm Hg.
There were four non-serious, related adverse reactions leading to discontinuation in the zilebesiran groups: two instances of orthostatic hypotension; one of blood pressure elevation; and one of injection site reaction. There were no adverse reactions in the placebo group.
The six-month, placebo-controlled treatment period of the Phase 2 trial reported here was conducted from July 2021 to June 2023.