Tests MANP injection for hard-to-control high blood pressure
Tests a daily MANP injection against placebo in adults with resistant hypertension.
Plain-language title generated from the registry record
Registry title: To Evaluate the Safety and Efficacy of MANP in Subjects With Difficult to Control/ Resistant Hypertension
Key facts
- Where
- Acworth, Chicago, Coppell, Dallas, Daytona Beach, Dearborn, Denton, Flint, Hollywood, Houston, Lake Forest, Little Rock, Mansfield, Miami, Monroe, New York, Plano, Richmond, Ridgeland, Sherman, Union City, and Westlake Village, United StatesSee the 23 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06343298, who can take part
Where in United States
- Cowry HealthAcworth, United StatesTaking people
- Cedar Crosse Research CenterChicago, United StatesTaking people
- Prime ResearchCoppell, United StatesNo longer taking part
- Dallas Renal GroupDallas, United StatesTaking people
- Arrow Clinical TrialsDaytona Beach, United StatesTaking people
- Revival Research Institute, LLCDearborn, United StatesTaking people
- Revival ResearchDenton, United StatesTaking people
- Aa Mrc LlcFlint, United StatesTaking people
- Royal Research, CorpHollywood, United StatesTaking people
- Aavon Clinical researchHouston, United StatesTaking people
- Pioneer Research SolutionsHouston, United StatesTaking people
- Orange County Research CenterLake Forest, United StatesTaking people
- Lynn Institute of the OzarksLittle Rock, United StatesTaking people
- Prime Clinical ResearchMansfield, United StatesTaking people
- Evolution Clinical TrialsMiami, United StatesTaking people
- Monroe Biomedical ResearchMonroe, United StatesTaking people
- Mt. SinaiNew York, United StatesTaking people
- Clinical Investigations of TexasPlano, United StatesTaking people
- Aavon Clinical TrialsRichmond, United StatesTaking people
- SKY CRNGRidgeland, United StatesTaking people
- Revival ResearchSherman, United StatesTaking people
- SKY CRNGUnion City, United StatesTaking people
- Office of Dr. Edward Portnoy MDWestlake Village, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- E-Star BioTech, LLC
- Trial code
- NCT06343298
- Record updated
- 23 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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 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; Subjects with an HbA1c ≥ 8% at screening (SV); Subjects meeting ANY of the following criteria at time of Screening will be excluded from enrollment:; Women of childbearing potential; Subjects who are pregnant or breastfeeding.