Mild to Moderate HypertensionPhase 1/2NCT06423352
A Study to Evaluate Zilebesiran in Japanese Patients With Mild to Moderate Hypertension
A Phase 1/2 study testing Zilebesiran in people with Mild to Moderate Hypertension, run by Alnylam Pharmaceuticals at 3 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mild to Moderate Hypertension
- What is being tested?
- Zilebesiran
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 3 sitesJapan
- Study dates
- 5 Jun 2024to 17 Jul 2025
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 <=165 mmHg by automated office blood pressure measurement, after a minimum of 3 weeks of washout if taking hypertensive medication
- Has 24-hour mean SBP ≥130 mmHg by ambulatory blood pressure monitoring (ABPM), without antihypertensive medication
Who cannot join
- Has secondary hypertension, symptomatic orthostatic hypotension
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >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)
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Clinical Trial Site
Fukuoka
Clinical Trial Site
Osaka
Clinical Trial Site
Tokyo
About this study
Official title: A Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacodynamics, and Pharmacokinetics of Zilebesiran in Japanese Patients With Mild to Moderate Hypertension
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.
- Conditions
- Mild to Moderate Hypertension
- Being tested
- Zilebesiran, Placebo
- Keywords
- High blood pressure, Hypertension, Hypertensive, siRNA, Angiotensinogen, AGT
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZilebesiranDrug
Also called ALN-AGT01
Zilebesiran administered by subcutaneous (SC) injection
PlaceboDrug
Placebo administered by SC injection
| Study group | Role | What they receive |
|---|---|---|
| Zilebesiran | Experimental | Participants will be administered a single dose of zilebesiran. Receives: Drug: Zilebesiran |
| Placebo | Placebo comparator | Participants will be administered a single dose of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Measured: Up to 12 months
Secondary outcomes (8)
Percent Change From Baseline in Serum Angiotensinogen (AGT) at Month 3 and Month 6
Measured: Baseline and Month 3 and Month 6
Change From Baseline at Month 3 and Month 6 in 24-hour Mean SBP and DBP Assessed by ABPM
Measured: Baseline and Month 3 and Month 6
Change From Baseline at Month 3 and Month 6 in SBP and DBP Assessed by OBP
Measured: Baseline and Month 3 and Month 6
Maximum Plasma Concentration (Cmax) of Zilebesiran and Its Metabolite
Cmax is the highest concentration of zilebesiran in the plasma and metabolite after a dose is given.
Measured: Predose and 30 minutes, 1, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose.
Time to Maximum Plasma Concentration (Tmax) of Zilebesiran and Its Metabolite
Tmax is the time it takes for zilebesiran to reach the Cmax after administration.
Measured: Predose and 30 minutes, 1, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose.
Elimination Half-life (t1/2) of Zilebesiran and Its Metabolite
t½ is the time it takes for the concentration of the drug in the plasma to be reduced by 50%.
Measured: Predose and 30 minutes, 1, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose.
Area Under the Curve (AUClast) of Zilebesiran and Its Metabolite
AUClast is the AUC from the time of dosing to the last measurable concentration of the drug.
Measured: Predose and 30 minutes, 1, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose.
Pooled Urine PK (fe) of Zilebesiran and Its Metabolite
Measured: Predose and 2 to 6, 6 to 12, and 12 to24 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start5 Jun 2024
- Primary completion17 Jul 2025
- Study completion17 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild to Moderate HypertensionStudies of the same condition, open and under way.
- More trials run by Alnylam PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alnylam Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Alnylam Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423352
- Sponsor's protocol ID
- ALN-AGT01-006
- Status last verified
- Apr 2026
- First submitted
- 15 May 2024
- Last updated
- 30 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to Anonymized individual participant data that support these results is made available 12 months after study completion and not less than 12 months after the product and indication have been approved in the US and/or the EU. Access to data may be declined where there is likelihood a patient could be identified or other feasibility issue, where there is a potential conflict of interest, a planned business activities or an actual or potential competitive risk. Data will be provided contingent upon the approval of a research proposal and the execution of a data sharing agreement. Timeframes for data access may vary and can take up to 6 months or more. Requests for access to data can be submitted via the website www.vivli.org. Questions can also be directed to datasharing@alnylam.com.