Phase 2
Completed N=36
A Study to Evaluate Zilebesiran in Japanese Patients With Mild to Moderate Hypertension
Mild to Moderate Hypertension
Source: ClinicalTrials.gov NCT06423352 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 6; 6; 4; 0 Participants
Summary
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacodynamics (PD) and pharmacokinetics (PK) of zilebesiran in Japanese patients with mild to moderate hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
6; 6; 4; 0; 1; 1 | — |
| SECONDARY Percent Change From Baseline in Serum Angiotensinogen (AGT) at Month 3 and Month 6 |
-96.85; -96.85; 6.93; -95.36; -95.79; -2.74 | — |
| SECONDARY Change From Baseline at Month 3 and Month 6 in 24-hour Mean SBP and DBP Assessed by ABPM |
-15.2; -17.8; 0.4; -12.6; -12.2; -6.5 | — |
| SECONDARY Change From Baseline at Month 3 and Month 6 in SBP and DBP Assessed by OBP |
-14.4; -14.4; 4.4; -10.3; -6.8; 1.2 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Zilebesiran and Its Metabolite |
1024; 2445; 101.4; 288.2 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of Zilebesiran and Its Metabolite |
3.53; 6.00; 8.01; 16.00 | — |
| SECONDARY Elimination Half-life (t1/2) of Zilebesiran and Its Metabolite |
5.83; 5.56; 9.42; 5.48 | — |
| SECONDARY Area Under the Curve (AUClast) of Zilebesiran and Its Metabolite |
16150; 41260; 1587; 4906 | — |
| SECONDARY Pooled Urine PK (fe) of Zilebesiran and Its Metabolite |
23.62; 30.08; 2.68; 3.85 | — |
Eligibility Criteria
Inclusion Criteria
- Must have been born in Japan, and their biological parents and grandparents must have been of Japanese origin
- Has mean systolic office blood pressure (SBP) of >130 and 2× upper limit of normal (ULN)
- Has elevated serum potassium >5 mmol/L
- Has estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m^2
- Has received an investigational agent within the last 30 days
- Has Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus or newly diagnosed Type 2 diabetes mellitus
- Has history of intolerance to SC injection(s)
Data sourced from ClinicalTrials.gov (NCT06423352). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.