Lorundrostat for High Blood Pressure

No longer recruiting at 107 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well a new drug, lorundrostat, can lower high blood pressure when added to a regular medication routine. Researchers aim to determine if lorundrostat can assist those who have not successfully controlled their blood pressure with other treatments. Participants will receive either a placebo (a pill with no active drug) or varying doses of lorundrostat for 12 weeks. This trial suits individuals with long-standing high blood pressure who currently take between two and five blood pressure medications. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that lorundrostat lowers blood pressure in individuals with hard-to-control hypertension. However, some reports indicate it can also cause more unwanted side effects. For example, one study found that lorundrostat significantly reduced the risk of very high blood pressure events but noted an increase in side effects compared to a placebo.

While lorundrostat effectively lowers blood pressure, potential side effects should be considered. Potential participants should discuss these risks with their healthcare provider when considering joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Lorundrostat for high blood pressure because it offers a novel approach to treatment. Unlike standard medications such as ACE inhibitors or beta-blockers, Lorundrostat targets the aldosterone pathway, which plays a key role in regulating blood pressure. This unique mechanism could provide a more effective option for patients who don't respond well to current treatments. Additionally, the potential for different dosing regimens allows for flexibility in managing various patient needs, making it a promising alternative in the hypertension treatment landscape.

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

Research has shown that lorundrostat can effectively lower blood pressure. One study demonstrated that lorundrostat significantly reduced average blood pressure over 24 hours compared to a placebo. Another study found that lorundrostat decreased the likelihood of dangerously high blood pressure. After four weeks, 42% of participants taking lorundrostat had their blood pressure under control, compared to only 19% of those on a placebo. This trial will evaluate different doses of lorundrostat, with some participants receiving a placebo for comparison. Overall, lorundrostat appears promising in effectively managing high blood pressure. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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. 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 ...

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

Efficacy and safety of lorundrostat in patients with ... Lorundrostat effectively controls blood pressure in patients with uncontrolled hypertension; however, it also increases the incidence of adverse ...

5. 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 ...

6. 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 ...