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NCT06343298PHASE2Recruiting

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

E-Star BioTech, LLC

Start Date

11/17/2024

Completion Date

9/30/2027

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.

Eligibility Criteria

Age Range: 18 years to 80 years

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

Interventions

DRUG

MANP

OTHER

Placebo Matched control

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Conditions

Difficult to Control Hypertension

Locations

Lynn Institute of the Ozarks

Little Rock, Arkansas 72204

United States

Orange County Research Center

Lake Forest, California 92630

United States

Office of Dr. Edward Portnoy MD

Westlake Village, California 91361

United States

Arrow Clinical Trials

Daytona Beach, Florida 32117

United States

Royal Research Corp

Hollywood, Florida 33021

United States

Evolution Clinical Trials

Miami, Florida 33122

United States

Cowry Health

Acworth, Georgia 30101

United States

SKY CRNG

Union City, Georgia 30291

United States

Cedar Crosse Research Center

Chicago, Illinois 60607

United States

Revival Research Institute, LLC

Dearborn, Michigan 48126

United States

Aa Mrc Llc

Flint, Michigan 48504

United States

SKY CRNG

Ridgeland, Mississippi 39157

United States

Mt.Sinai

New York, New York 10029

United States

Monroe Biomedical Research

Monroe, North Carolina 28112

United States

Prime Research

Coppell, Texas 75019

United States

Dallas Renal Group

Dallas, Texas 75230

United States

Revival Research

Denton, Texas 76210

United States

Aavon Clinical research

Houston, Texas 77074

United States

Pioneer Research Solutions

Houston, Texas 77099

United States

Prime Clinical Research

Mansfield, Texas 76063

United States

Clinical Investigations of Texas

Plano, Texas 75075

United States

Aavon Clinical Trials

Richmond, Texas 77407

United States

Revival Research

Sherman, Texas 75092

United States