Trial results for the Phase 1/2 study (NCT06423352) investigating zilebesiran in Japanese patients with mild to moderate hypertension were posted on ClinicalTrials.gov on 2026-04-30. The study evaluated safety, tolerability, efficacy, pharmacodynamics, and pharmacokinetics. Adverse event data showed 6 participants in the 300 mg zilebesiran group, 6 participants in the 600 mg zilebesiran group, and 4 participants in the placebo group experienced adverse events.
Background
Zilebesiran was investigated in a study focused on mild to moderate hypertension. Hypertension is a common condition characterized by high blood pressure, which can increase the risk of cardiovascular diseases.
Trial design
The study (NCT06423352) was a Phase 1/2, randomized, placebo-controlled trial that enrolled 36 participants. The trial investigated zilebesiran in Japanese patients diagnosed with mild to moderate hypertension. Participants were assigned to receive either zilebesiran at varying doses or a placebo. The study's purpose was to evaluate the safety, tolerability, efficacy, pharmacodynamics (PD), and pharmacokinetics (PK) of zilebesiran.
Key results
The trial results included data on the number of participants who experienced adverse events (AEs). For the outcome of "Number of Participants With Adverse Events (AEs)":
- In the Zilebesiran 300 mg group, 6 participants experienced AEs.
- In the Zilebesiran 600 mg group, 6 participants experienced AEs.
- In the Placebo group, 4 participants experienced AEs.
What this means
The posted results provide initial safety and tolerability data for zilebesiran in Japanese patients with mild to moderate hypertension. The observed adverse event rates across the zilebesiran dose groups and placebo will inform further development of the drug for this patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT06423352, titled "A Study to Evaluate Zilebesiran in Japanese Patients With Mild to Moderate Hypertension," were posted on 2026-04-30 on clinicaltrials.gov.