Lorundrostat for High Blood Pressure

Recruiting at 106 trial locations

Overseen By Jeffrey Wayne, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mineralys Therapeutics Inc.

Must be taking: Antihypertensives

Disqualifiers: Heart failure, Myocardial infarction, Stroke, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

285 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, it mentions that lorundrostat will be added to your existing blood pressure medication regimen, so you will likely continue taking your current 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 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.

Inclusion Criteria

Your weight and height measurements give you a body mass index (BMI) between 18 and 40.

Exclusion Criteria

I haven't had cancer in the last 5 years, except for skin cancer or carcinoma in-situ.

I am on essential heart/blood pressure medication that cannot be stopped.

I have not been in a trial for new treatments or drugs in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Standardized AHT Regimen Run-in

Participants undergo a standardized antihypertensive medication regimen run-in period

2-4 weeks

Treatment

Participants receive either lorundrostat or placebo once daily for 12 weeks

12 weeks

End of Study Visit

Participants not entering the open-label extension undergo an end of study visit approximately 2 weeks after the last dose

2 weeks

Open-label Extension (optional)

Participants may opt into continuation of treatment long-term

Treatment Details

Interventions

• Lorundrostat

Trial Overview 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.

Participant Groups

Group I: Dose 2 Experimental Treatment 1 Intervention

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

Group II: Dose 1 Experimental Treatment 1 Intervention

lorundrostat Dose 1 once daily for 12 weeks

Group III: Placebo Placebo Group 1 Intervention

Placebo once daily 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

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]

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]

References

1. 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]

2. 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]

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

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

5. 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]