HypertensionPhase 2NCT07553442
A Study to Evaluate ALN-AGT01 RVR in Adult Patients With Mild to Moderate Hypertension Pretreated With Zilebesiran
A Phase 2 study testing ALN-AGT01 RVR and Zilebesiran in people with Hypertension, run by Alnylam Pharmaceuticals at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy, pharmacodynamics (PD), and safety of ALN-AGT01 RVR in participants with mild to moderate hypertension pretreated with zilebesiran. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- ALN-AGT01 RVR and Zilebesiran
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Apr 2026to 1 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
Part A: Inclusion Criteria
- Is an adult participant with a mean seated office systolic blood pressure (SBP) of at least 130 mmHg and no more than than 170 mmHg
- Either not taking antihypertensive medication or on stable therapy with up to 2 antihypertensive medications
Part B: Inclusion Criteria
- Is an adult participant with a mean seated office SBP of at least 140 mmHg and no more than 170 mmHg
- Has discontinued all prior antihypertensive medication other than a calcium channel blocker (CCB) and/or thiazide/thiazide-like diuretic (if taking) for at least 3 weeks
Both Parts: Exclusion Criteria
- Has known secondary hypertension or serum potassium more than 5 mmol/L
- Has an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m^2
Note: other protocol defined inclusion / exclusion criteria apply
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 1 recruiting
- Recruiting
Clinical Trial Site
Lake Forest, California, 92630
- Active, not recruiting
Clinical Trial Site
Savannah, Georgia, 31405
- Active, not recruiting
Clinical Trial Site
Tampa, Florida, 33613
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Single Dose Study of the Efficacy, Pharmacodynamics, and Safety of ALN-AGT01 RVR in Adult Patients With Mild to Moderate Hypertension Pretreated With Zilebesiran
The purpose of this study is to evaluate the efficacy, pharmacodynamics (PD), and safety of ALN-AGT01 RVR in participants with mild to moderate hypertension pretreated with zilebesiran.
Read the detailed description
This study will be conducted in 2 parts:
- Part A: Single dose (SD), dose-ranging part in adults with mild to moderate hypertension.
- Part B: SD in adults with mild to moderate hypertension.
- Conditions
- Hypertension
- Being tested
- ALN-AGT01 RVR, Placebo, Zilebesiran
- Keywords
- RNAi therapeutic, oligonucleotide, Reversir, Zilebesiran, ALN-AGT01
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALN-AGT01 RVRDrug
ALN-AGT01 RVR will be administered subcutaneously (SC)
PlaceboDrug
Placebo will be administered SC
ZilebesiranDrug
Zilebesiran will be administered SC
| Study group | Role | What they receive |
|---|---|---|
| ALN-AGT1 RVR | Experimental | Participants will be administered a single dose of zilebesiran followed by a single dose of ALN-AGT01 RVR. Receives: Drug: ALN-AGT01 RVR; Drug: Zilebesiran |
| Placebo | Placebo comparator | Participants will be administered a single dose of zilebesiran followed by a single dose of placebo. Receives: Drug: Placebo; Drug: Zilebesiran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Percentage recovery from baseline in serum AGT
Measured: Up to Day 4
Part B: Percentage recovery from baseline in mean seated office SBP
Measured: At Day 4 and Day 7
Secondary outcomes (4)
Both Parts: Frequency of Adverse Events (AEs)
Measured: Up to 10 months
Part A: Percentage recovery from baseline in serum AGT
Measured: Up to Day 7
Part B: Percentage recovery from baseline in serum AGT
Measured: At Day 4 and Day 7
Part B: Change from baseline in mean seated office SBP
Measured: At Day 4 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start27 Apr 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alnylam Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Alnylam Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553442
- Sponsor's protocol ID
- ALN-AGT01 RVR-002
- Status last verified
- Oct 2026
- First submitted
- 22 Apr 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled, Single Dose Study of the Efficacy, Pharmacodynamics, and Safety of ALN-AGT01 RVR in Adult Patients With Mild to Moderate Hypertension Pretreated With Zilebesiran
- ClinicalTrials.gov ID
- NCT07553442
- Acronym / sponsor ID
- ALN-AGT01 RVR-002
- Conditions
- Hypertension
- Keywords
- RNAi therapeutic, oligonucleotide, Reversir, Zilebesiran, ALN-AGT01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Alnylam PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy, pharmacodynamics (PD), and safety of ALN-AGT01 RVR in participants with mild to moderate hypertension pretreated with zilebesiran.
Detailed description
This study will be conducted in 2 parts:
- Part A: Single dose (SD), dose-ranging part in adults with mild to moderate hypertension.
- Part B: SD in adults with mild to moderate hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALN-AGT1 RVR | Experimental | Drug: ALN-AGT01 RVR, Drug: ZilebesiranParticipants will be administered a single dose of zilebesiran followed by a single dose of ALN-AGT01 RVR. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: ZilebesiranParticipants will be administered a single dose of zilebesiran followed by a single dose of placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALN-AGT01 RVRALN-AGT01 RVR will be administered subcutaneously (SC) | Drug | ALN-AGT1 RVR |
| PlaceboPlacebo will be administered SC | Drug | Placebo |
| ZilebesiranZilebesiran will be administered SC | Drug | ALN-AGT1 RVR, Placebo |
Primary outcome
Part A: Percentage recovery from baseline in serum AGT
Time frame: Up to Day 4
Part B: Percentage recovery from baseline in mean seated office SBP
Time frame: At Day 4 and Day 7
4 secondary outcomes
Both Parts: Frequency of Adverse Events (AEs)
Time frame: Up to 10 months
Part A: Percentage recovery from baseline in serum AGT
Time frame: Up to Day 7
Part B: Percentage recovery from baseline in serum AGT
Time frame: At Day 4 and Day 7
Part B: Change from baseline in mean seated office SBP
Time frame: At Day 4 and Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Alnylam Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALN-AGT01 RVR and Zilebesiran in people with Hypertension, run by Alnylam Pharmaceuticals at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alnylam Clinical Trial Information Line (1-877-ALNYLAM, clinicaltrials@alnylam.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Percentage recovery from baseline in serum AGT (time frame: Up to Day 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.