Lorundrostat for High Blood Pressure

Recruiting at 185 trial locations

Overseen By Judy Thuo

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Mineralys Therapeutics Inc.

Must be taking: Antihypertensives

Disqualifiers: Pregnancy, Heart failure, Myocardial infarction, Stroke, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

1083 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial does not specify that you need to stop taking your current medications. In fact, it requires participants to be on 2 to 5 blood pressure medications.

How does the drug Lorundrostat differ from other high blood pressure treatments?

Lorundrostat is unique because it is an aldosterone synthase inhibitor, which means it specifically targets and reduces the production of aldosterone, a hormone that can increase blood pressure. This mechanism is different from many other blood pressure medications, which often work by relaxing blood vessels or reducing heart rate. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

Taking between 2 and 5 AHT medications

Body mass index (BMI) of ≥18 kg/m2 at Screening

Are you taking at least 2 to 5 medications for your high blood pressure?

Exclusion Criteria

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

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

Are you a current night shift worker or night shift worker for more than 14 days continuously?

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Run-in

Single-blind run-in period to stabilize participants on study protocol

2 weeks

Treatment

Randomized, double-blind, placebo-controlled period where participants receive either lorundrostat or placebo

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term with lorundrostat

Treatment Details

Interventions

• Lorundrostat

Trial Overview 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.

Participant Groups

Group I: Dose 2 Experimental Treatment 1 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 1 Experimental Treatment 1 Intervention

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

Group III: Placebo Placebo Group 1 Intervention

Placebo once daily (QD) for 12 weeks

Who Is Running the Clinical Trial?

Mineralys Therapeutics Inc.

Lead Sponsor

Trials

6

Recruited

3,100+

Founded

2019

Headquarters

Radnor, USA

Known For

Hypertension treatments

Top Products

Lorundrostat

Findings from Research

In a study involving 27 healthy volunteers, the co-administration of baxdrostat with metformin was found to be safe, with no serious adverse events or significant increases in side effects, indicating good tolerance of the combination.

Baxdrostat did not significantly alter the plasma levels or renal clearance of metformin, suggesting that diabetic patients with hypertension can take both medications without needing to adjust the metformin dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results From a Randomized, Open-Label, Crossover Study Evaluating the Effect of the Aldosterone Synthase Inhibitor Baxdrostat on the Pharmacokinetics of Metformin in Healthy Human Subjects. Freeman, MW., Bond, M., Murphy, B., et al.[2023]

Baxdrostat (CIN-107) is a selective aldosterone synthase inhibitor being tested as a treatment for drug-resistant hypertension, which is linked to serious cardiovascular issues.

While a phase 2 trial (BrigHTN) showed promising efficacy results, the HALO trial found no significant blood pressure-lowering effect of baxdrostat compared to placebo, indicating the need for further studies to assess its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baxdrostat: An Aldosterone Synthase Inhibitor for the Treatment of Systemic Hypertension. Dey, S., Frishman, WH., Aronow, WS.[2023]

Baxdrostat, a selective aldosterone synthase inhibitor, was found to be safe and well-tolerated in a study of 54 healthy volunteers, with no serious adverse events reported and only mild side effects observed.

The study demonstrated that baxdrostat effectively reduced plasma aldosterone levels by 51 to 73% after 10 days of treatment at doses of 1.5 mg or higher, while having no significant impact on cortisol levels, indicating its selective action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results from a phase 1, randomized, double-blind, multiple ascending dose study characterizing the pharmacokinetics and demonstrating the safety and selectivity of the aldosterone synthase inhibitor baxdrostat in healthy volunteers. Freeman, MW., Bond, M., Murphy, B., et al.[2023]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Results From a Randomized, Open-Label, Crossover Study Evaluating the Effect of the Aldosterone Synthase Inhibitor Baxdrostat on the Pharmacokinetics of Metformin in Healthy Human Subjects. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Baxdrostat: An Aldosterone Synthase Inhibitor for the Treatment of Systemic Hypertension. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Association of Antihypertensive Effects of Esaxerenone with the Internal Sodium Balance in Dahl Salt-Sensitive Hypertensive Rats. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

Rationale and Design of the Efficacy and Safety of Esaxerenone in Hypertensive Patients With Left Ventricular Hypertrophy (ESES-LVH) Study - Protocol for a Multicenter, Open-Label, Exploratory Interventional Study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Results from a phase 1, randomized, double-blind, multiple ascending dose study characterizing the pharmacokinetics and demonstrating the safety and selectivity of the aldosterone synthase inhibitor baxdrostat in healthy volunteers. [2023]