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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Difficult to Control Hypertension

In brief

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.

Key facts

Study ID: NCT06343298
Run by: E-Star BioTech, LLC
People needed: 120
Starts: 2024-11-17
Expected to finish: 2026-09-01
Last updated by the study team: 2025-10-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 3 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 ≥135 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.

You may not qualify if…

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

Where it is running

Revival Research — Sherman, Texas, United States (enrolling)
Amicis Research Center - Beverly Hills — Beverly Hills, California, United States (enrolling)
Amicis Research Center - Granada Hills — Granada Hills, California, United States (enrolling)
Orange County Research Center — Lake Forest, California, United States (enrolling)
Amicis Research Center - Palmdale — Palmdale, California, United States (enrolling)
Amicis Research Site - Valencia — Valencia, California, United States (enrolling)
Clinical Investigations of Texas — Plano, Texas, United States (enrolling)
Aavon Clinical Trials — Richmond, Texas, United States (enrolling)
Lynn Institute of the Ozarks — Little Rock, Arkansas, United States (enrolling)
Office of Dr. Edward Portnoy MD — Westlake Village, California, United States (enrolling)
SM Research Center — Biscayne Park, Florida, United States (enrolling)
Arrow Clinical Trials — Daytona Beach, Florida, United States (enrolling)
Royal Research Corp — Hollywood, Florida, United States (enrolling)
Evolution Clinical Trials — Miami, Florida, United States (enrolling)
Cowry Health — Acworth, Georgia, United States (enrolling)
Alta Pharmaceutical Research Center — Peachtree Corners, Georgia, United States (enrolling)
Cedar Crosse Research Center — Chicago, Illinois, United States (enrolling)
Revival Research Institute, LLC — Dearborn, Michigan, United States (enrolling)
Aa Mrc Llc — Flint, Michigan, United States (enrolling)
Monroe Biomedical Research — Monroe, North Carolina, United States (enrolling)
Superior Clinical Research — Smithfield, North Carolina, United States (enrolling)
K&R Research LLC — Marion, Ohio, United States (enrolling)
Dallas Renal Group — Dallas, Texas, United States (enrolling)
East Texas Cardiology — Houston, Texas, United States (enrolling)
Pioneer Research Solutions — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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