CompletedPhase 2

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

United States285 participantsStarted 2023-03-13

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

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

What they're measuring

Change in 24-hour average ambulatory blood pressure monitoring (ABPM) systolic blood pressure (SBP)

Timeframe: Baseline (Randomization) to Week 12

Trial details

NCT IDNCT05769608

SponsorMineralys Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-15

View on ClinicalTrials.gov More Hypertension trials