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RecruitingPhase 1 / Phase 2

A Trial Evaluating Safety, Tolerability and Efficacy of CTX340 in Participants With Hypertension

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Subjects will receive CTX340 or placebo via intravenous (IV) infusion."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests CTX340 for high blood pressure that stays high despite treatment. It looks at how safe it is, how well people tolerate it, and how well it works in adults ages 18 to 75.

A Study of CTX340 in Participants with Uncontrolled Hypertension.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 75 years old.
  • Your body mass index (BMI), a measure of weight compared with height, is 40 or less.
  • Your average top blood pressure number over 24 hours is 130 to 160 mm Hg despite treatment.
  • You take at least 4 blood pressure medicines at effective doses. At least 1 must be a diuretic, or water pill.
  • If you have ever been able to become pregnant, you must now be past menopause.
  • If you can produce sperm, you must agree to use an accepted, effective birth control method. Any partner who can become pregnant must also agree to use effective birth control.

Who can't join

  • Blood tests suggest primary aldosteronism, a condition where too much of the hormone aldosterone can raise blood pressure.
  • Your average bottom blood pressure number is 65 mm Hg or less during the 24-hour screening test.
  • Your high blood pressure has a cause that can be treated or reversed, including a blood vessel problem that may be fixed by restoring blood flow.
  • In the past 12 months, you had a procedure to disrupt nerves around the kidney arteries to lower blood pressure.
  • Your blood pressure drops when you stand up.
  • Your blood cell counts are outside the study's allowed ranges, or you have a history of a major blood-clotting disorder.
  • You have signs of liver disease.
  • You have thyroid disease that is untreated or not controlled.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: 1. Age: ≥18 and ≤75 years. 2. Body mass index ≤40 kg/m2. 3. 24-hour mean ambulatory blood pressure monitoring (ABPM) systolic blood pressure (SBP) measurement of ≥130 mm Hg but ≤160 mm Hg despite treatment 4. Be on treatment with ≥4 antihypertensive therapies at effective doses, of which ≥1 must be a diuretic. 5. Participants who at any point had childbearing potential must currently be postmenopausal 6. 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: 1. Serum aldosterone and direct renin concentration (or plasma renin activity \[PRA\]) suggestive of primary aldosteronism 2. Mean diastolic blood pressure (DBP) ≤65 mm Hg on screening ABPM. 3. Participants with vascular cause of hypertension which may be amendable to revascularization 4. Participants with treatable/reversible causes of uncontrolled hypertension 5. History of renal artery denervation within past 12 months. 6. Orthostatic hypotension 7. Complete blood count (CBC) outside the specified ranges per protocol. 8. Evidence of liver disease 9. History of a significant coagulation disorder. 10. Uncontrolled or untreated thyroid disease

Study sites (1)

FL