Recruiting

Phase 2

MANPTo Evaluate the Safety and Efficacy of MANP in Subjects With Difficult to Control/ Resistant Hypertension

Sponsor:

E-Star BioTech, LLC

Code:

NCT06343298

Conditions

Difficult to Control Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MANP

Placebo Matched control

Study Details

Brief summary:

This is a Phase 2 dose-titration study designed to evaluate the safety and efficacy of MANP subcutaneous injection compared to placebo in reducing baseline daytime systolic blood pressure (SBP), derived from 24-hour ambulatory blood pressure monitoring (ABPM), in subjects with hypertension who are taking 3 or more antihypertensive medications with different mechanisms of action.

Conditions

Difficult to Control Hypertension

Study ID

NCT06343298

Start date

Nov 17, 2024

Status verified date

Sep, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Subjects will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening:

Male or female subjects aged 18 - 80 years, inclusive, at the screening visit.
Female subjects must not be of childbearing potential
Subjects must be taking appropriate doses of 2 or more antihypertensive drugs with different mechanisms of action. One of which must be a diuretic and the other must be an ACEi or ARB at atleast 50% of the maximum recommended dose for hypertension.
Subjects must have a seated (5 minutes) systolic blood pressure ≥ 140 mmHg and SBP ≥130 mmHg by ABPM prior to randomization (T1).
Subjects must have a CKD-EPI eGFR ≥ 30 mL/min/1.73m2
A subset of the subjects with an eGFR between 20-30 ml/min/1.73m2 will be included, not to exceed 10% of the total study subjects.
Subjects must have a BMI between 18 - 40 kg/m2.
Subjects who engage in sexual intercourse in which their partner could become pregnant must agree to use a barrier method of birth control (i.e., vaginal/penile condom) with spermicide for the duration of the study and for 90 days after the last dose of study drug or be at least 6 weeks post-vasectomy with confirmation by post-vasectomy semen analysis. In addition, subjects may not donate sperm for the duration of the study and for 90 days after the last dose of study drug.

Exclusion Criteria:

Subjects meeting ANY of the following criteria at time of Screening will be excluded from enrollment:

Subjects with an average sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥ 110 mmHg at Screening (SV), or prior to randomization at T1.
Subjects with a history of secondary hypertension, including but not limited to coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's disease, pheochromocytoma, and polycystic kidney disease. If the subject has not previously been evaluated for secondary hypertension, investigators are responsible for evaluating all potential secondary causes of hypertension in accordance with current practices and clinical guidelines before entering the patient into the study.
Subjects with an HbA1c ≥ 8% at screening (SV)
Subjects who have experienced myocardial infarction, unstable angina, or a cerebrovascular accident (CVA) within 6 months of the Screening Visit; or sick sinus syndrome or second- or third-degree atrioventricular block, or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia.
Subjects who have an implanted cardioverter defibrillator (ICD) that has been fired for any arrhythmia within 3 months of Screening (SV) or implanted pacemakers.
Subjects with congestive heart failure (New York Heart Association \[NYHA\] class II-IV)
Subjects with hemodynamically significant valvular heart disease
Subjects undergoing hemodialysis or peritoneal dialysis, or history of renal transplant.
Subjects who have diagnosis or recurrence of malignancy within the past 3 years
Subjects with a documented history of sleep apnea, with a prescription for CPAP therapy.
Women of childbearing potential
Subjects who are pregnant or breastfeeding

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo-matched control

Placebo-matched vehicle (vehicle minus the active component)

active comparator: MANP

MANP in vehicle

Interventions

MANP

MANP (modified atrial natriuretic peptide) is a peptide that is being developed for treatment of difficult to control/resistant hypertension.

Placebo Matched control

This is a placebo matched vehicle - Vehicle minus the active ingredient

Primary outcome measure

Change from baseline in mean daytime SBP derived from 24-hour ABPM at approximately Day 42. [ Time Frame: Approximately 42 days ]
Incidence and severity of Adverse events through 4- weeks post end of treatment. [ Time Frame: Approximately 10 weeks ]
Incidence and severity of Serious Adverse Events through 4- weeks post end of treatment. [ Time Frame: Approximately 10 weeks ]
Incidence and severity of Treatment Emergent Adverse Events through 4- weeks post end of treatment. [ Time Frame: Approximately 10 weeks ]

Central Contacts and Locations

Central contacts

Seetha R Iyer, MS

212-271-4295 sri@icw.ventures

Locations

Lynn Institute of the Ozarks

Recruiting

Little Rock, Arkansas, United States, 72204

Contacts

BOLD-HTN

MANPTo Evaluate the Safety and Efficacy of MANP in Subjects With Difficult to Control/ Resistant Hypertension

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

More Information