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Evaluating a new treatment for difficult to control 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

Phase 2 Interventional E-Star BioTech, LLC · NCT06343298

This study is testing a new injection to see if it can help people with hard-to-control high blood pressure lower their daytime blood pressure better than a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment120 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorE-Star BioTech, LLC Industry-sponsored
Locations29 sites (Little Rock, Arkansas and 28 other locations)
Trial IDNCT06343298 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study aims to assess the safety and efficacy of MANP, a subcutaneous injection, in reducing daytime systolic blood pressure in patients with resistant hypertension. Participants must be on three or more antihypertensive medications and will be compared to a placebo group. The study involves dose titration and utilizes 24-hour ambulatory blood pressure monitoring to measure outcomes. The goal is to determine if MANP can effectively lower blood pressure in this challenging patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with resistant hypertension who are already on multiple antihypertensive medications.

Not a fit: Patients who are not taking multiple antihypertensive medications or have contraindications to the study drug may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with difficult to control hypertension, potentially improving their blood pressure management.

How similar studies have performed: Other studies have shown promise in treating resistant hypertension with novel approaches, but this specific treatment is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion 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 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 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

Where this trial is running

Little Rock, Arkansas and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Difficult to Control HypertensionResistant Hypertension
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.