CTX340 in Adults with Uncontrolled Hypertension
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
Run by CRISPR Therapeutics · NCT07758634 · Data updated 2026-11-12
This study tests CTX340 versus placebo to see if it safely lowers blood pressure in adults with uncontrolled hypertension already on multiple meds.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 69 (estimated) |
| Sponsor | CRISPR Therapeutics Industry-sponsored |
| Locations | 2 sites (Port Orange, Florida and 1 other locations) |
| Status | Recruiting |
| Started | August 8, 2026 |
| Main results expected | July 1, 2028 |
| Study ends | July 1, 2029 |
| Registry record updated | August 11, 2026 |
| Trial ID | NCT07758634 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with uncontrolled hypertension (24-hour SBP 130–160 mm Hg) on at least four antihypertensive drugs, including a diuretic.
✕Probably not a fit
Patients who do not respond to CTX340 or who experience intolerable adverse effects may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a dose-escalation, early-phase study testing CTX340 in adults with hypertension who remain above target blood pressure despite multiple therapies. Participants will be randomized to receive CTX340 or placebo by IV infusion, with monitoring for safety, tolerability, and preliminary efficacy. The trial includes two phases (Phase 1/2) and aims to identify a safe dose range and signals of blood pressure reduction. Eligible individuals are adults 18 to 75 on at least four antihypertensive medications, including a diuretic, and with certain blood pressure criteria. The study is conducted at two sites in Florida and is sponsored by CRISPR Therapeutics AG.
Why it matters
Potential benefit: If successful, CTX340 could offer an additional treatment option to help lower blood pressure in patients with resistant hypertension.
How similar studies have gone: Earlier hypertension programs with novel biologics have shown potential in reducing BP, but CTX340 represents a new mechanism and is being studied for safety and preliminary efficacy.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Research Site 1
Port Orange, Florida, United States Recruiting -
Research Site 2
Melbourne, Australia Recruiting
Study contacts
- Study coordinator: Clinical Trials
- Email: medicalaffairs@crisprtx.com
- Phone: 877-214-4634
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.