What side effects are associated with this type of intervention?

Common treatments for high blood pressure, such as mineralocorticoid receptor antagonists (e.g., spironolactone and eplerenone), can cause side effects including hyperkalemia (elevated potassium levels), gynecomastia (breast enlargement in men), and renal impairment. Other antihypertensive medications, like ACE inhibitors (e.g., lisinopril), may cause cough, dizziness, and hypotension. Beta-blockers can lead to fatigue, bradycardia (slow heart rate), and depression. Calcium channel blockers might cause peripheral edema (swelling of the lower limbs) and constipation. Diuretics can result in electrolyte imbalances and dehydration.

What prior FDA approvals exist?

FDA-approved treatments for high blood pressure include various classes of medications such as angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta-blockers, calcium channel blockers, and diuretics. Specifically, aldosterone receptor antagonists like spironolactone and eplerenone have been used to manage resistant hypertension. These drugs block the effects of aldosterone, a hormone that increases blood pressure by causing the kidneys to retain sodium and water. Lorundrostat, an aldosterone synthase inhibitor currently in Phase 3 trials, represents a novel approach by inhibiting the synthesis of aldosterone itself, potentially offering a new therapeutic option for patients with uncontrolled and resistant hypertension.

What other types of research exist?

Promising novel alternatives to Lorundrostat for high blood pressure patients include: <ol> <li>Angiotensin Receptor Blockers (ARBs) such as Valsartan and Irbesartan, which have shown efficacy in various trials.</li> <li></li> </ol> Sodium-Glucose Co-Transporter-2 (SGLT2) inhibitors like Dapagliflozin and Empagliflozin, which have demonstrated cardiovascular benefits in addition to blood pressure reduction. 3. Renin-Angiotensin System (RAS) inhibitors, which continue to be a cornerstone in hypertension management. 4. Newer agents like Omecamtiv Mecarbil, which is being studied for its effects on heart failure and may have implications for hypertension management.

← Back to Search

Aldosterone Synthase Inhibitor

Lorundrostat for High Blood Pressure

Verified Trial

Phase 3

Waitlist Available

Research Sponsored by Mineralys Therapeutics Inc.

Eligibility Criteria Checklist

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

Must have

At least 18 years of age at the time of signing the informed consent form (ICF)

At Screening and Randomization: AOBP SBP of ≥135 and ≤180 mmHg plus AOBP DBP of ≥65 and ≤110 mmHg, or AOBP DBP of ≥90 and ≤110 mmHg

Must not have

Any hospitalizations to treat severely elevated blood pressure in the last year?

Any current or known nervous system conditions? (ex. Alzheimers, cerebral palsy, epilepsy, MS, and Parkinson's)

Timeline

Screening 4 weeks

Treatment 12 weeks

Follow Up 2 weeks

Awards & highlights

Pivotal Trial

Summary

This trial tests lorundrostat, a medication that lowers blood pressure by blocking an enzyme involved in hormone production. It targets patients with high blood pressure not controlled by 2 to 5 other medications.

Who is the study for?

This trial is for adults over 18 with uncontrolled and resistant high blood pressure, despite taking 2-5 blood pressure medications. Participants must have a history of hypertension for at least 6 months, an office-based blood pressure reading within certain ranges, and a BMI of ≥18 kg/m2.

What is being tested?

The trial is testing the effectiveness of lorundrostat at two different doses compared to a placebo in lowering blood pressure. Lorundrostat is an aldosterone synthase inhibitor. This Phase 3 study involves patients who are already on multiple anti-hypertensive drugs.

What are the potential side effects?

While specific side effects for lorundrostat aren't listed here, common side effects for this type of medication may include dizziness, headache, fatigue, gastrointestinal issues or electrolyte imbalances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

Your blood pressure at screening and randomization should be between 135/65 and 180/110, or your diastolic blood pressure should be between 90 and 110.

Select...

I have had high blood pressure for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 4 weeks2 visits

Treatment ~ 12 weeks5 visits

Follow Up ~ 2 weeks1 visit

Screening ~ 4 weeks

Treatment ~ 12 weeks

Follow Up ~2 weeks

This trial's timeline: 4 weeks for screening, 12 weeks for treatment, and 2 weeks 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 from baseline in AOBP SBP at Week 12 in subjects randomized to lorundrostat Dose 1 with escalation to lorundrostat Dose 2

Change from baseline in automated office BP (AOBP) SBP at Week 12 in subjects randomized to lorundrostat

Secondary study objectives

Change from baseline in AOBP SBP at Week 12 by obesity status in combined lorundrostat dosages

Change from baseline in AOBP SBP at Week 12 in subjects who did not reach SBP control by Week 6 on lorundrostat Dose 1 and were increased to lorundrostat Dose 2 (within-subjects analysis)

Change from baseline in AOBP SBP at Week 12 in subjects with resistant hypertension in combined lorundrostat dosages

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Dose 2Experimental Treatment1 Intervention

50 mg lorundrostat Dose 1 once daily (QD) for 6 weeks then 100 mg lorundrostat Dose 2 once daily (QD) for 6 weeks for subjects who meet prespecified criteria

Group II: Dose 1Experimental Treatment1 Intervention

50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks

Group III: PlaceboPlacebo Group1 Intervention

Placebo once daily (QD) for 12 weeks

0 / 9Eligibility criteria met

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

High blood pressure treatments often target different mechanisms to reduce blood pressure effectively. Aldosterone synthase inhibitors, like Lorundrostat, work by blocking the production of aldosterone, a hormone that increases sodium retention and blood pressure. By inhibiting aldosterone, these drugs help reduce fluid retention and lower blood pressure. Other common treatments include ACE inhibitors and ARBs, which relax blood vessels by blocking the formation or action of angiotensin II, a potent vasoconstrictor. Diuretics help the kidneys remove excess sodium and water, reducing blood volume and pressure. Calcium channel blockers prevent calcium from entering heart and blood vessel cells, leading to relaxed vessels and lower pressure. Understanding these mechanisms is crucial for patients, as it helps tailor treatment plans to individual needs and improves management of high blood pressure.

The mineralocorticoid receptor in skin disease.Novel non-steroidal mineralocorticoid receptor antagonists in cardiorenal disease.Sex Differences in Outcomes and Responses to Spironolactone in Heart Failure With Preserved Ejection Fraction: A Secondary Analysis of TOPCAT Trial.