What side effects are associated with this type of intervention?

Common treatments for high blood pressure include aldosterone antagonists like spironolactone and eplerenone, as well as other antihypertensive medications such as beta-blockers, ACE inhibitors, and thiazide diuretics. Aldosterone antagonists can cause side effects like hyperkalemia (elevated potassium levels), gynecomastia (breast tissue growth in men), and potential feminization of male fetuses if taken during pregnancy. Beta-blockers may lead to fatigue, depression, and bradycardia (slow heart rate). ACE inhibitors can cause a persistent dry cough and, in rare cases, angioedema (swelling). Thiazide diuretics might result in electrolyte imbalances, particularly low potassium levels, and increased uric acid levels, which can exacerbate gout.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of high blood pressure, including angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta-blockers, calcium channel blockers, and diuretics. Specifically related to aldosterone, aldosterone receptor antagonists like spironolactone and eplerenone have been approved for managing hypertension and heart failure. These drugs work by blocking the effects of aldosterone, a hormone that increases blood pressure by causing the kidneys to retain sodium and water. Lorundrostat, an aldosterone synthase inhibitor, represents a newer approach by inhibiting the synthesis of aldosterone itself, potentially offering a novel mechanism for blood pressure control.

What other types of research exist?

Promising novel alternatives to Lorundrostat for high blood pressure treatment include SGLT2 inhibitors, which are recommended for patients with diabetic kidney disease and hypertension, and finerenone, which is suggested for patients with albuminuria despite other therapies. Both have shown efficacy in managing blood pressure and providing additional kidney protection.

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Aldosterone Synthase Inhibitor

Lorundrostat for High Blood Pressure

Verified Trial

Phase 2

Recruiting

Research Sponsored by Mineralys Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Summary

This trial tests lorundrostat, a drug that lowers blood pressure by blocking a hormone that makes the body hold onto salt and water. It targets patients whose high blood pressure isn't controlled by standard treatments.

Who is the study for?

This trial is for adults with a BMI of 18-40 who have high blood pressure not controlled by standard medications. It's not for those with recent serious cancers (except certain skin cancers), or people at risk if they stop their current heart meds. Also excluded are those with recent heart attacks, strokes, drug abuse, certain allergies, and conditions that could affect the study.

What is being tested?

The trial tests lorundrostat at two different doses versus a placebo to see how well it lowers blood pressure when taken alongside usual hypertension drugs. Lorundrostat blocks aldosterone production which can contribute to high blood pressure.

What are the potential side effects?

While specific side effects of lorundrostat aren't listed here, similar medications may cause dizziness due to low blood pressure, increased potassium levels in the blood, kidney issues, and hormonal imbalances.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in 24-hour mean ambulatory blood pressure monitoring (ABPM) systolic blood pressure (SBP) from Week 0 (randomization) to Week 12

Secondary study objectives

Change in 24-hour mean ABPM diastolic blood pressure (DBP)

Change in 24-hour mean central DBP

Change in 24-hour mean central SBP

+12 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Dose 2Experimental Treatment1 Intervention

lorundrostat Dose 1 once daily for 4 weeks then lorundrostat Dose 2 once daily for 8 weeks

Group II: Dose 1Experimental Treatment1 Intervention

lorundrostat Dose 1 once daily for 12 weeks

Group III: PlaceboPlacebo Group1 Intervention

Placebo once daily for 12 weeks

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high blood pressure work through various mechanisms to lower blood pressure and prevent complications. Aldosterone synthase inhibitors like Lorundrostat reduce aldosterone levels, decreasing sodium and water retention, which lowers blood volume and pressure. ACE inhibitors and ARBs block the RAAS, preventing vasoconstriction and reducing blood volume. Diuretics help eliminate excess sodium and water, further reducing blood volume. Calcium channel blockers relax blood vessels by inhibiting calcium entry into cells, and beta-blockers lower heart rate and contraction force. These mechanisms are vital for patients to understand as they explain how medications help manage blood pressure and reduce the risk of cardiovascular events.

The mineralocorticoid receptor in skin disease.Novel non-steroidal mineralocorticoid receptor antagonists in cardiorenal disease.Hypertension Management in Stroke Prevention: Time to Consider Primary Aldosteronism.