RecruitingPhase 2

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

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE TITRATION, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS MANP WHEN ADMINISTERED ONCE DAILY FOR 42 DAYS IN PARTICIPANTS WITH DIFFICULT TO CONTROL HYPERTENSION/RESISTANT HYPERTENSION

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether MANP shots under the skin are safe and lower blood pressure compared with a placebo, a shot with no active drug. It is for adults with high blood pressure that is hard to control despite taking several blood pressure medicines.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 80 years old.
  • Women must not be able to become pregnant.
  • Take at least 2 blood pressure drugs that work in different ways, at suitable doses. One must be a water pill (diuretic). Another must be an ACE inhibitor or ARB, drugs that relax blood vessels, at half the highest recommended dose or more.
  • Have a top blood pressure number of at least 140 after sitting for 5 minutes, and at least 130 on a monitor worn for 24 hours.
  • Have an eGFR (a measure of how well the kidneys filter blood) of at least 30. A small group, no more than 10% of participants, may have an eGFR between 20 and 30.
  • Have a BMI (a measure of weight compared with height) between 18 and 40.
  • If your partner could become pregnant, use a condom with sperm-killing medicine during the study and for 90 days after the last dose. Or, have had a vasectomy at least 6 weeks earlier, with a semen test confirming it worked.
  • Do not donate sperm during the study or for 90 days after the last dose.

Who can't join

  • Have an average seated blood pressure with a top number of 180 or higher, or a bottom number of 110 or higher.
  • Have high blood pressure caused by another medical condition, or an HbA1c of 8% or higher (a blood test showing average blood sugar).
  • Had a heart attack, unstable chest pain, or stroke in the past 6 months; or have certain heart rhythm problems, heart signal blocks, or a slow heartbeat that causes symptoms.
  • Have a pacemaker, or an implanted heart device that gave a shock for an abnormal rhythm in the past 3 months.
  • Have heart failure rated class II to IV, or heart valve disease that greatly affects blood flow.
  • Receive dialysis, a treatment that filters the blood, or have had a kidney transplant.
  • Had cancer diagnosed or return in the past 3 years, or have sleep apnea (breathing pauses during sleep) with prescribed CPAP breathing treatment.
  • Are able to become pregnant, are pregnant, or are breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (23)

AR

CA

FL

GA

IL

MI

MS

NC

NY

TX