NCT07758634 · CRISPR Therapeutics AG
A Trial Evaluating Safety, Tolerability and Efficacy of CTX340 in Participants With Hypertension
What this study is about
A Study of CTX340 in Participants with Uncontrolled Hypertension.
View original scientific description
A Study of CTX340 in Participants with Uncontrolled Hypertension.
Interventions
DRUG
CTX340
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.
DRUG
Placebo
One of the arms in Phase 2 will be placebo.
Primary outcome measures
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- 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
Where
- Port Orange, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 11, 2026 · Source of record for eligibility and locations