ClinicalTrials.gg
RecruitingNCT07758634Updated Aug 11, 2026

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

A Phase 1/2 interventional study of CTX340 and Placebo in Hypertension, sponsored by CRISPR Therapeutics AG. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by CRISPR Therapeutics AG · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
69
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hypertension

Browse trials for

03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's planned enrollment of 69 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

CRISPR Therapeutics AG is the lead sponsor of 12 studies on the registry; 5 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Age: ≥18 and ≤75 years.
  2. ≤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 must currently be
  6. All participants capable of producing sperm must agree to the use of an acceptable method of effective 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
69 participants (estimated)

Study arms

  • Experimental
    Phase 1: CTX340

    Phase 1 is An Open-Label, Ascending Dose Design.

    Drug: CTX340

  • Experimental
    Phase 2: Recommended Phase 2 Dose CTX340

    Phase 2: Recommended Phase 2 Dose CTX340.

    Drug: CTX340

  • Experimental
    Phase 2: Placebo

    Phase 2: Placebo.

    Drug: Placebo

Interventions

  • DrugCTX340

    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.

  • DrugPlacebo

    One of the arms in Phase 2 will be placebo.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Up to 12 months

  2. 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)

    Time frame: Through 6 months of follow-up.

Secondary outcomes

  1. 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.

    Time frame: From CTX340 infusion up to 12 months

  2. 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)

    Time frame: From CTX340 infusion up to 12 months

  3. To assess the pharmacodynamics (PD) effect of CTX340

    Percentage change in circulating angiotensinogen (AGT) concentrations over time compared to baseline.

    Time frame: Over 12 months, compared to baseline

  4. To characterize the pharmacokinetics (PK) of CTX340

    Plasma levels of LNP (ionizable lipid and PEG lipid)

    Time frame: From CTX340 infusion up to 12 months

07

Study locations

2 of 2 sites recruiting
  • Research Site 1
    Port Orange, Florida 32127, United States
    Recruiting
  • Research Site 2
    Melbourne, 3168, Australia
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Jul 2028, 22 months later.

Of 20 phase 1/2 interventional studies under Hypertension, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 60. This study's planned 22 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2026
First posted
Aug 11, 2026
StartEst.
Aug 8, 2026
Primary completionEst.
Jul 1, 2028
CompletionEst.
Jul 1, 2029
Last update
Aug 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07758634
Lead sponsor
CRISPR Therapeutics AG
Responsible party
Sponsor
First posted
Aug 11, 2026
Start date
Aug 8, 2026 (estimated)
Primary completion
Jul 1, 2028 (estimated)
Completion
Jul 1, 2029 (estimated)
Last update
Aug 11, 2026

Study contacts

Clinical Trials
Contact
medicalaffairs@crisprtx.com
877-214-4634

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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