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
Study 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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Change from baseline in mean daytime SBP derived from 24-hour ABPM at approximately Day 42. — Approximately 42 days ABPM
Incidence and severity of Adverse events through 4- weeks post end of treatment. — Approximately 10 weeks Safety
Incidence and severity of Serious Adverse Events through 4- weeks post end of treatment. — Approximately 10 weeks Safety
Incidence and severity of Treatment Emergent Adverse Events through 4- weeks post end of treatment. — Approximately 10 weeks Safety
Trial sites (23)
Facility
City
Region
Status
Lynn Institute of the Ozarks
Little Rock
Arkansas
Recruiting
Orange County Research Center
Lake Forest
California
Recruiting
Office of Dr. Edward Portnoy MD
Westlake Village
California
Recruiting
Arrow Clinical Trials
Daytona Beach
Florida
Recruiting
Royal Research Corp
Hollywood
Florida
Recruiting
Evolution Clinical Trials
Miami
Florida
Recruiting
Cowry Health
Acworth
Georgia
Recruiting
SKY CRNG
Union City
Georgia
Recruiting
Cedar Crosse Research Center
Chicago
Illinois
Recruiting
Revival Research Institute, LLC
Dearborn
Michigan
Recruiting
Aa Mrc Llc
Flint
Michigan
Recruiting
SKY CRNG
Ridgeland
Mississippi
Recruiting
Mt.Sinai
New York
New York
Recruiting
Monroe Biomedical Research
Monroe
North Carolina
Recruiting
Prime Research
Coppell
Texas
Active Not Recruiting
Dallas Renal Group
Dallas
Texas
Recruiting
Revival Research
Denton
Texas
Recruiting
Aavon Clinical research
Houston
Texas
Recruiting
Pioneer Research Solutions
Houston
Texas
Recruiting
Prime Clinical Research
Mansfield
Texas
Recruiting
Clinical Investigations of Texas
Plano
Texas
Recruiting
Aavon Clinical Trials
Richmond
Texas
Recruiting
Revival Research
Sherman
Texas
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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