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

ConditionHypertension
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCRISPR Therapeutics AG

About this trial

A Study of CTX340 in Participants with Uncontrolled Hypertension.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • CTX340

    Drug

    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.

  • Placebo

    Drug

    One of the arms in Phase 2 will be placebo.

Treatment groups

69 Participants
are divided into 3 treatment groups
Group A: Phase 1: CTX340Experimental treatment 1 intervention
Group B: Phase 2: Recommended Phase 2 Dose CTX340Experimental treatment 1 intervention
Group C: Phase 2: PlaceboExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CRISPR Therapeutics AG

Lead sponsor

Source ClinicalTrials.gov
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