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New shot could tame stubborn high blood pressure

NCT ID NCT06343298

Disease control Sponsor: E-Star BioTech, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a daily injection called MANP for people whose high blood pressure remains high despite taking three or more different medications. About 120 adults aged 18 to 80 will receive either MANP or a placebo for 42 days. The main goal is to see if MANP safely lowers daytime blood pressure measured over 24 hours.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MANP (modified atrial natriuretic peptide)
What this could lead to
If successful, this could offer a new daily injection option for people whose high blood pressure is not controlled by multiple oral medications.
What could go wrong
This is an early Phase 2 trial with only 120 participants, so results may not apply to everyone. The injection is daily for 42 days, and side effects or lack of effectiveness are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

resistant hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Difficult to control hypertension

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    26 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aa Mrc Llc

    RECRUITING

    Flint, Michigan, 48504, United States

  • Aavon Clinical Trials

    RECRUITING

    Richmond, Texas, 77407, United States

  • Alta Pharmaceutical Research Center

    RECRUITING

    Peachtree Corners, Georgia, 30092, United States

  • Amicis Research Center - Beverly Hills

    RECRUITING

    Beverly Hills, California, 90211, United States

  • Amicis Research Center - Granada Hills

    RECRUITING

    Granada Hills, California, 91344, United States

  • Amicis Research Center - Palmdale

    RECRUITING

    Palmdale, California, 93551, United States

  • Amicis Research Site - Valencia

    RECRUITING

    Valencia, California, 91355, United States

  • Arrow Clinical Trials

    RECRUITING

    Daytona Beach, Florida, 32117, United States

  • Cedar Crosse Research Center

    RECRUITING

    Chicago, Illinois, 60607, United States

  • Clinical Investigations of Texas

    RECRUITING

    Plano, Texas, 75075, United States

  • Cowry Health

    RECRUITING

    Acworth, Georgia, 30101, United States

  • Dallas Renal Group

    RECRUITING

    Dallas, Texas, 75230, United States

  • East Texas Cardiology

    RECRUITING

    Houston, Texas, 77002, United States

  • Evolution Clinical Trials

    RECRUITING

    Miami, Florida, 33122, United States

  • Interventional Cardiology Medical Group

    WITHDRAWN

    West Hills, California, 91308, United States

  • K&R Research LLC

    RECRUITING

    Marion, Ohio, 43302, United States

  • Lynn Institute of the Ozarks

    RECRUITING

    Little Rock, Arkansas, 72204, United States

  • Monroe Biomedical Research

    RECRUITING

    Monroe, North Carolina, 28112, United States

  • Office of Dr. Edward Portnoy MD

    RECRUITING

    Westlake Village, California, 91361, United States

  • Orange County Research Center

    RECRUITING

    Lake Forest, California, 92630, United States

  • Pioneer Research Solutions

    RECRUITING

    Houston, Texas, 77099, United States

  • Prime Clinical Research

    RECRUITING

    Mansfield, Texas, 76063, United States

  • Prime Research

    ACTIVE_NOT_RECRUITING

    Coppell, Texas, 75019, United States

  • Revival Research

    RECRUITING

    Sherman, Texas, 75092, United States

  • Revival Research Institute, LLC

    RECRUITING

    Dearborn, Michigan, 48126, United States

  • Royal Research Corp

    RECRUITING

    Hollywood, Florida, 33021, United States

  • SM Research Center

    RECRUITING

    Biscayne Park, Florida, 33161, United States

  • Superior Clinical Research

    RECRUITING

    Smithfield, North Carolina, 27577, United States

  • Tristar Clinical Investigations, P.C.

    ACTIVE_NOT_RECRUITING

    Philadelphia, Pennsylvania, 19114, United States