HypertensionPhase 1/2NCT07758634
A Trial Evaluating Safety, Tolerability and Efficacy of CTX340 in Participants With Hypertension
A Phase 1/2 study testing CTX340 in people with Hypertension, run by CRISPR Therapeutics AG at 2 sites in 2 countries.
Trial summary
A Study of CTX340 in Participants with Uncontrolled Hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- CTX340
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 Aug 2026to 1 Jul 2029
- Phase
- Phase 1/2
- 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
Who may be able to join
- Age: ≥18 and ≤75 years.
- Body mass index ≤40 kg/m2.
- 24-hour mean ambulatory blood pressure monitoring (ABPM) systolic blood pressure (SBP) measurement of ≥130 mm Hg but ≤160 mm Hg despite treatment
- Be on treatment with ≥4 antihypertensive therapies at effective doses, of which ≥1 must be a diuretic.
- Participants who at any point had childbearing potential must currently be postmenopausal
- All participants capable of producing sperm must agree to the use of an acceptable method of effective contraception and their partners with childbearing potential should also agree to use an effective method of contraception.
Who cannot join
- Serum aldosterone and direct renin concentration (or plasma renin activity [PRA]) suggestive of primary aldosteronism
- Mean diastolic blood pressure (DBP) ≤65 mm Hg on screening ABPM.
- Participants with vascular cause of hypertension which may be amendable to revascularization
- Participants with treatable/reversible causes of uncontrolled hypertension
- History of renal artery denervation within past 12 months.
- Orthostatic hypotension
Show all 10Show fewer
- Complete blood count (CBC) outside the specified ranges per protocol.
- Evidence of liver disease
- History of a significant coagulation disorder.
- Uncontrolled or untreated thyroid disease
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Research Site 1
Port Orange, Florida, 32127
About this study
Official title: A Phase 1/2 Multicenter, First-in-human, Ascending Dose Trial Evaluating the Safety, Tolerability, and Efficacy of a Lipid Nanoparticle Formulation of CRISPR-Guide RNA-Cas9 Nuclease (CTX340) for In Vivo Editing of the Angiotensinogen (AGT) Gene in Participants With Hypertension
A Study of CTX340 in Participants with Uncontrolled Hypertension.
Read the detailed description
This is a dose ascending study of CTX340 in participants with hypertension. Subjects will receive CTX340 or placebo via intravenous (IV) infusion.
- Conditions
- Hypertension
- Being tested
- CTX340, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTX340Drug
CTX340 is an in vivo gene editing therapy designed to utilize clustered regularly interspaced short palindromic repeats-CRISPR-associated protein 9 (CRISPR-Cas9) to target and disrupt human angiotensinogen (AGT) gene in liver.
PlaceboDrug
One of the arms in Phase 2 will be placebo.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: CTX340 | Experimental | Phase 1 is An Open-Label, Ascending Dose Design. Receives: Drug: CTX340 |
| Phase 2: Recommended Phase 2 Dose CTX340 | Experimental | Phase 2: Recommended Phase 2 Dose CTX340. Receives: Drug: CTX340 |
| Phase 2: Placebo | Experimental | Phase 2: Placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Incidence of dose-limiting toxicities (DLTs)
To evaluate the safety and tolerability of a single ascending dose of CTX340 in participants with hypertension to determine the recommended Phase 2 dose (RP2D).
Measured: Up to 12 months
Phase 2: Percentage change in circulating angiotensinogen (AGT) concentration from baseline
To evaluate the pharmacodynamics (PD) effect of CTX340 at the recommended Phase 2 dose (RP2D)
Measured: Through 6 months of follow-up.
Secondary outcomes (4)
To assess the safety of CTX340
Incidence of adverse events (AEs), including treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs), clinically significant laboratory abnormalities, and clinically significant abnormal vital signs during 12 months of follow-up.
Measured: From CTX340 infusion up to 12 months
To assess the effect of CTX340 on systolic blood pressure (SBP) by ambulatory blood pressure monitoring (ABPM)
Change from baseline in systolic blood pressure (SBP) assessed by 24-hour ambulatory blood pressure monitoring (ABPM)
Measured: From CTX340 infusion up to 12 months
To assess the pharmacodynamics (PD) effect of CTX340
Percentage change in circulating angiotensinogen (AGT) concentrations over time compared to baseline.
Measured: Over 12 months, compared to baseline
To characterize the pharmacokinetics (PK) of CTX340
Plasma levels of LNP (ionizable lipid and PEG lipid)
Measured: From CTX340 infusion up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start8 Aug 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2029 (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.
- 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1: Sequential Single Ascending Dose Escalation Phase 2: Placebo Controlled Parallel Group
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CRISPR Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758634
- Sponsor's protocol ID
- CRSP-CVD-402
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Multicenter, First-in-human, Ascending Dose Trial Evaluating the Safety, Tolerability, and Efficacy of a Lipid Nanoparticle Formulation of CRISPR-Guide RNA-Cas9 Nuclease (CTX340) for In Vivo Editing of the Angiotensinogen (AGT) Gene in Participants With Hypertension
- ClinicalTrials.gov ID
- NCT07758634
- Acronym / sponsor ID
- CRSP-CVD-402
- Conditions
- Hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- CRISPR Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 11 Aug 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.
A Study of CTX340 in Participants with Uncontrolled Hypertension.
Detailed description
This is a dose ascending study of CTX340 in participants with hypertension. Subjects will receive CTX340 or placebo via intravenous (IV) infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Phase 1: Sequential Single Ascending Dose Escalation Phase 2: Placebo Controlled Parallel Group
| Arm | Type | Receives |
|---|---|---|
| Phase 1: CTX340 | Experimental | Drug: CTX340Phase 1 is An Open-Label, Ascending Dose Design. |
| Phase 2: Recommended Phase 2 Dose CTX340 | Experimental | Drug: CTX340Phase 2: Recommended Phase 2 Dose CTX340. |
| Phase 2: Placebo | Experimental | Drug: PlaceboPhase 2: Placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: ≥18 and ≤75 years.
- Body mass index ≤40 kg/m2.
- 24-hour mean ambulatory blood pressure monitoring (ABPM) systolic blood pressure (SBP) measurement of ≥130 mm Hg but ≤160 mm Hg despite treatment
- Be on treatment with ≥4 antihypertensive therapies at effective doses, of which ≥1 must be a diuretic.
- Participants who at any point had childbearing potential must currently be postmenopausal
Key exclusion criteria (10 listed)
- Serum aldosterone and direct renin concentration (or plasma renin activity [PRA]) suggestive of primary aldosteronism
- Mean diastolic blood pressure (DBP) ≤65 mm Hg on screening ABPM.
- Participants with vascular cause of hypertension which may be amendable to revascularization
- Participants with treatable/reversible causes of uncontrolled hypertension
- History of renal artery denervation within past 12 months.
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 |
|---|---|---|
| CTX340CTX340 is an in vivo gene editing therapy designed to utilize clustered regularly interspaced short palindromic repeats-CRISPR-associated protein 9 (CRISPR-Cas9) to target and disrupt human angiotensinogen (AGT) gene in liver. | Drug | Phase 1: CTX340, Phase 2: Recommended Phase 2 Dose CTX340 |
| PlaceboOne of the arms in Phase 2 will be placebo. | Drug | Phase 2: Placebo |
Primary outcome
Phase 1: Incidence of dose-limiting toxicities (DLTs)
Time frame: Up to 12 months
To evaluate the safety and tolerability of a single ascending dose of CTX340 in participants with hypertension to determine the recommended Phase 2 dose (RP2D).
Phase 2: Percentage change in circulating angiotensinogen (AGT) concentration from baseline
Time frame: Through 6 months of follow-up.
To evaluate the pharmacodynamics (PD) effect of CTX340 at the recommended Phase 2 dose (RP2D)
4 secondary outcomes
To assess the safety of CTX340
Time frame: From CTX340 infusion up to 12 months
To assess the effect of CTX340 on systolic blood pressure (SBP) by ambulatory blood pressure monitoring (ABPM)
Time frame: From CTX340 infusion up to 12 months
To assess the pharmacodynamics (PD) effect of CTX340
Time frame: Over 12 months, compared to baseline
To characterize the pharmacokinetics (PK) of CTX340
Time frame: From CTX340 infusion up to 12 months
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 11 Aug 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CTX340 in people with Hypertension, run by CRISPR Therapeutics AG at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. 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 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Australia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Clinical Trials (877-214-4634, medicalaffairs@crisprtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Incidence of dose-limiting toxicities (DLTs) (time frame: Up to 12 months). 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 11 Aug 2026.