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To Evaluate the Safety and Efficacy of MANP in Subjects With Difficult to Control/ Resistant Hypertension

NCT06343298 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-10-06

No results posted yet for this study

Summary

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.

Conditions

  • Difficult to Control Hypertension

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

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • PPD Development, LP

    collaborator INDUSTRY

  • E-Star BioTech, LLC

    lead INDUSTRY

Principal Investigators

  • David Smith, MD · E-Star BioTech, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-17
Primary Completion
2026-07-01
Completion
2026-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06343298 on ClinicalTrials.gov