Phase 2 Study of MANP for Difficult to Control Hypertension
This study is testing a new medication called MANP (modified atrial natriuretic peptide) for people with high blood pressure that is difficult to control, even with three or more other blood pressure medications. We want to see if MANP is safe and effective at lowering your daytime systolic blood pressure (the top number in your blood pressure reading). You might be able to join if you are between 18 and 80 years old and are currently taking at least three different blood pressure medications. The study will compare MANP to a placebo (an inactive substance) to see how well it works. We are looking for 120 participants, but the current status of recruitment is unclear.
- Study design
- This is a Phase 2 study that will compare MANP to a placebo. About 120 participants are planned to join this study.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for about 4 weeks after your treatment ends, which is approximately 10 weeks from the start of the study.
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NCT06343298
To Evaluate the Safety and Efficacy of MANP in Subjects With Difficult to Control/ Resistant Hypertension
Recruiting
PHASE2Ages 18–80InterventionalTreatmentE-Star BioTech, LLC
~120 participants
Updated 2025-10-06 on ClinicalTrials.gov
What's tested:MANPPlacebo Matched control
At a glance
Recruiting sites
26 of 29 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in mean daytime SBP derived from 24-hour ABPM at approximately Day 42.
Measured over Approximately 42 days
+3 more outcomes measured
Conditions
Where it's being run
29 sites across 10 statesTexas8
California7
Florida4
Georgia2
Michigan2
North Carolina2
Arkansas1
Illinois1
Study leadership
- David Smith, MD · STUDY_DIRECTOR · E-Star BioTech, LLC
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Exclusion
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
What this trial measures
- 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