This study is in progress, not accepting new patients

A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects with Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen

a study on High Blood Pressure

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine UCSD
Dates
study started
completion around

Description

Summary

A Phase 2 trial to evaluate the blood pressure-lowering effect of lorundrostat an aldosterone synthase inhibitor (ASI), administered as an add-on to a standardized anti-hypertensive (AHT) medication regimen, in subjects with hypertension.

Official Title

A Randomized, Double-Blind, Placebo Controlled, Parallel Arm, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Lorundrostat in Subjects with Uncontrolled Hypertension on a Standardized Medication Regimen

Details

This study is a Phase 2 trial to evaluate the blood pressure-lowering effects of lorundrostat (an ASI), administered as add-on to a standardized anti-hypertensive (AHT) medication regimen, in subjects with hypertension.

The study consists of a standardized AHT regimen run-in period followed by a randomized, double-blind, placebo-controlled, parallel arm period. Following the double-blind period subjects may be offered the opportunity to participate in an open-label extension (OLE) study. Subjects electing to not participate in the OLE will undergo an end of study (EoS) visit approximately 2 weeks after the last dose of study drug to complete their participation in the study.

Keywords

Hypertension, Blood pressure, Uncontrolled hypertension, Hypertensive, Resistant hypertension, lorundrostat Dose 1, lorundrostat Dose 2

Eligibility

You can join if…

Open to people ages 18 years and up

  1. At least 18 years of age at the time of signing the informed consent form
  2. At Screening: AOBP SBP of 140-180 mmHg and AOBP DBP of 65-110 mmHg, or AOBP DBP of 90-110 mmHg
  3. 24-hour average ABPM SBP of 130-180 mmHg or 24-hour average ABPM DBP >80 mmHg
  4. Taking between 2 and 5 AHT medications, inclusive, at Screening visit.
  5. BMI of 18-40 kg/m2 inclusive at Screening

You CAN'T join if...

  1. eGFR <45 mL/min/1.73 m2 at Screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
  2. Serum potassium >5.0 mmol/L at Screening or >4.8 mmol/L at Randomization
  3. Serum sodium <135 mmol/L at Screening
  4. History of heart failure, myocardial infarction, stroke, or transient ischemic attack within 6 months prior to Screening.
  5. Diabetes mellitus with a glycosylated hemoglobin (HbA1c) >9% (>74.9 mmol/mol) at Screening

Locations

  • University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI)
    La Jolla California 92037 United States
  • University of California Irvine Medical Center
    Orange California 92868 United States
  • Cedars-Sinai Medical Center
    Los Angeles California 90048 United States
  • The Medical Research Group Inc.
    Fresno California 93720 United States
  • Triwest Research Associates
    San Diego California 92108 United States
  • Marvel Clinical Research
    Huntington Beach California 92647 United States
  • Northridge Clinical Trials
    Northridge California 91325 United States
  • Blue Coast Research Center
    Vista California 92081 United States
  • Accelerated Enrollment Solutions (AES)- Vista
    Vista California 92083 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mineralys Therapeutics Inc.
ID
NCT05769608
Phase
Phase 2 High Blood Pressure Research Study
Study Type
Interventional
Participants
About 285 people participating
Last Updated