NCT07758634

Brief Summary

A Study of CTX340 in Participants with Uncontrolled Hypertension.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P75+ for phase_1 hypertension

Timeline
35mo left

Started Aug 2026

Longer than P75 for phase_1 hypertension

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

August 8, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

1.9 years

First QC Date

August 6, 2026

Last Update Submit

August 6, 2026

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

  • 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).

    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)

    Through 6 months of follow-up.

Secondary Outcomes (4)

  • To assess the safety of CTX340

    From CTX340 infusion up to 12 months

  • To assess the effect of CTX340 on systolic blood pressure (SBP) by ambulatory blood pressure monitoring (ABPM)

    From CTX340 infusion up to 12 months

  • To assess the pharmacodynamics (PD) effect of CTX340

    Over 12 months, compared to baseline

  • To characterize the pharmacokinetics (PK) of CTX340

    From CTX340 infusion up to 12 months

Study Arms (3)

Phase 1: CTX340

EXPERIMENTAL

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

Drug: CTX340

Phase 2: Recommended Phase 2 Dose CTX340

EXPERIMENTAL

Phase 2: Recommended Phase 2 Dose CTX340.

Drug: CTX340

Phase 2: Placebo

EXPERIMENTAL

Phase 2: Placebo.

Drug: Placebo

Interventions

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.

Phase 1: CTX340Phase 2: Recommended Phase 2 Dose CTX340
PlaceboDRUG

One of the arms in Phase 2 will be placebo.

Phase 2: Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: ≥18 and ≤75 years.
  • Body mass index ≤40 kg/m2.
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site 1

Port Orange, Florida, 32127, United States

RECRUITING

Research Site 2

Melbourne, 3168, Australia

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Clinical Trials

CONTACT

877-214-4634medicalaffairs@crisprtx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Phase 1 is Open-Label, while Phase 2 is Double-Blind (Participant, Investigator)
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Phase 1: Sequential Single Ascending Dose Escalation Phase 2: Placebo Controlled Parallel Group
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2026

First Posted

August 11, 2026

Study Start

August 8, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2029

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)AU(1)