NCT06343298 · E-Star BioTech, LLC
To Evaluate the Safety and Efficacy of MANP in Subjects With Difficult to Control/ Resistant Hypertension
(BOLD-HTN)
What this study is about
This is a Phase 2 dose-titration study designed to evaluate the safety and effectiveness of MANP injected under the skin 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.
View original scientific 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.
Interventions
DRUG
MANP
MANP (modified atrial natriuretic peptide) is a peptide that is being developed for treatment of difficult to control/resistant hypertension.
OTHER
Placebo Matched control
This is a placebo matched vehicle - Vehicle minus the active ingredient
Primary outcome measures
Change from baseline in mean daytime SBP derived from 24-hour ABPM at approximately Day 42.
Time frame: Approximately 42 days
ABPM
Incidence and severity of Adverse events through 4- weeks post end of treatment.
Time frame: Approximately 10 weeks
Safety
Incidence and severity of Serious Adverse Events through 4- weeks post end of treatment.
Time frame: Approximately 10 weeks
Safety
Incidence and severity of Treatment Emergent Adverse Events through 4- weeks post end of treatment.
Time frame: Approximately 10 weeks
Safety
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Little Rock, Arkansas
- Beverly Hills, California
- Granada Hills, California
- Lake Forest, California
- Palmdale, California
- Valencia, California
- West Hills, California
- Westlake Village, California
- Biscayne Park, Florida
- Daytona Beach, Florida
- Hollywood, Florida
- Miami, Florida
And 16 more locations — see the full list below.
Collaborators
Mayo Clinic, PPD Development, LP
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 6, 2025 · Source of record for eligibility and locations