Lorundrostat for High Blood Pressure

No longer recruiting at 194 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called lorundrostat to determine if it can lower high blood pressure (hypertension) in individuals whose condition remains uncontrolled by their current medications. Participants will take either lorundrostat or a placebo (an inactive pill) once daily for 12 weeks. The trial targets individuals who have had high blood pressure for at least six months and are currently taking between two and five medications to manage it. Participants should have blood pressure readings within a specific range, despite their current treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that lorundrostat is likely to be safe for humans?

Research has shown that lorundrostat, a treatment being tested for high blood pressure, was generally well-tolerated by patients in earlier studies. In these studies, lorundrostat significantly lowered blood pressure in individuals with uncontrolled and hard-to-treat high blood pressure.

While the treatment showed positive effects, considering any risks is important. Some studies noted side effects, but they were uncommon. The details of these side effects remain unclear, but they do not appear severe for most people.

Overall, lorundrostat seems to be a promising option for lowering blood pressure, with a safety profile that appears acceptable based on past research. However, weighing the benefits and risks is always crucial when considering participation in a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for high blood pressure?

Unlike the standard high blood pressure treatments, which often include ACE inhibitors or beta blockers, Lorundrostat operates through a unique mechanism. It works by inhibiting aldosterone synthase, an enzyme involved in the production of aldosterone, a hormone that can raise blood pressure. This targeted approach could potentially lead to more effective blood pressure control with fewer side effects. Researchers are excited about Lorundrostat because it offers a novel pathway for managing high blood pressure, particularly in cases where traditional medications may not be as effective.

What evidence suggests that lorundrostat might be an effective treatment for high blood pressure?

Research has shown that lorundrostat helps lower blood pressure in people with hard-to-control high blood pressure. One study found that lorundrostat significantly reduced the average blood pressure over 24 hours compared to a placebo (a pill with no active medicine). Another study revealed that 42% of people taking lorundrostat had their blood pressure under control after four weeks, while only 19% of those taking the placebo did. Lorundrostat also reduced the risk of dangerously high blood pressure spikes. Overall, lorundrostat has effectively lowered blood pressure, making it a promising option for those who have difficulty managing their high blood pressure. Participants in this trial will receive either a 50 mg or 100 mg dose of lorundrostat or a placebo, allowing for a comprehensive evaluation of its effectiveness. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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, 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]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2501440

Lorundrostat Efficacy and Safety in Patients with ... Lorundrostat was associated with greater reductions in 24-hour average blood pressure than placebo in participants with uncontrolled and treatment-resistant ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12459306/

Efficacy and Safety of Lorundrostat in Uncontrolled Hypertension Lorundrostat also significantly lowered the risk of severely elevated BP events (odds ratio [OR]: 0.37; 95% CI: 0.17–0.81; p = 0.028). Adverse ...

3. acc.org acc.org/About-ACC/Press-Releases/2025/03/29/17/24/Lorundrostat-Lowers-Blood-Pressure-Compared

Lorundrostat Lowers Blood Pressure Compared with ... At four weeks, 42% of those taking lorundrostat had their blood pressure under control, compared with 19% in the placebo group. “Lorundrostat ...

4. ahajournals.org ahajournals.org/doi/10.1161/hyp.82.suppl_1.TH103

Abstract TH103: Efficacy and Safety of Lorundrostat in ... Results: The analysis encompassed the total sample size of 485 patients. Lorundrostat significantly reduced mean systolic blood pressure by 6.96 ...

5. ir.mineralystx.com ir.mineralystx.com/news-events/press-releases/detail/80/mineralys-therapeutics-presents-subgroup-analyses-of-phase

Mineralys Therapeutics Presents Subgroup Analyses of ... “Lorundrostat demonstrated a clinically meaningful blood pressure reduction across the full study population, including these difficult-to-treat ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1537189125000898

Efficacy and safety of lorundrostat in patients with ... Our findings demonstrated that Lorundrostat significantly reduced systolic blood pressure (SBP) by 8.26 mmHg and diastolic blood pressure ...

7. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2025/03/27/15/49/advance-htn

Lorundrostat Efficacy and Safety in Patients With ... The Advance-HTN trial showed that lorundrostat effectively lowered 24-hour SBP at 12 weeks among patients with uncontrolled and treatment-resistant ...