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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 belowSelect...
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 2 prescribed AHT medications
Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 3 or more prescribed AHT medications
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
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.
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.
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Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Mineralys Therapeutics Inc.Lead Sponsor
4 Previous Clinical Trials
1,945 Total Patients Enrolled