Lorundrostat for High Blood Pressure

Not currently recruiting at 184 trial locations

Overseen By Shannon Spires

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Mineralys Therapeutics Inc.

Must not be taking: Prohibited medications

Disqualifiers: Pregnancy, Breast-feeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of lorundrostat for individuals with high blood pressure. Lorundrostat blocks a chemical in the body that raises blood pressure. Participants will receive either lorundrostat or a placebo (a pill with no active medicine) to assess its long-term effects. This trial suits those who have already participated in a lorundrostat study and completed the previous phases. As a Phase 3 trial, it serves as the final step before FDA approval, providing participants an opportunity to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications, but it mentions that certain medications are prohibited. It's best to discuss your current medications with the study team to see if they are allowed.

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

Research has shown that lorundrostat is generally safe for people with high blood pressure. Studies have found that it effectively lowers blood pressure both in the doctor's office and throughout the day. Importantly, these studies also indicate that lorundrostat has a good safety record. Participants experienced fewer side effects compared to those taking a placebo, a non-active substance used for comparison.

In one study, lorundrostat reduced the top number in a blood pressure reading by about 7 to 8 points, with a low risk of side effects. The treatment did not cause major problems, suggesting it is quite safe for most people. These findings may reassure those considering joining a trial about the treatment's safety. ^{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, beta-blockers, or diuretics, lorundrostat stands out because it targets a different pathway. Researchers are excited about lorundrostat because it inhibits aldosterone synthase, potentially offering a more precise way to manage high blood pressure. This novel mechanism could mean fewer side effects associated with traditional blood pressure medications, making it a promising option for patients who struggle with current treatments.

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

Previous studies have shown that lorundrostat holds promise for lowering high blood pressure. Research indicates that lorundrostat led to larger drops in average blood pressure compared to a placebo. Specifically, one study found that 42% of patients taking lorundrostat had their blood pressure under control in just four weeks, compared to only 19% with a placebo. Additionally, lorundrostat significantly reduced the chances of experiencing very high blood pressure events. These findings suggest that lorundrostat could effectively manage high blood pressure. Participants in this trial will receive lorundrostat in different study arms, including an open-label arm and a double-blind randomized treatment withdrawal substudy. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with uncontrolled high blood pressure who have previously participated in a lorundrostat study. They must agree to use contraception and follow the study's instructions. Pregnant or breastfeeding women, or those planning pregnancy, cannot participate.

Inclusion Criteria

Written informed consent signed by the participant, obtained before any study-related assessment is performed

Fertile male subjects and female subjects of childbearing potential, and their partners, must agree to use an acceptable method of contraception from study entry to 28 days after the last dose of study drug

Willing and able to comply with the study instructions and attend all scheduled study visits

Exclusion Criteria

I am not pregnant, planning to become pregnant, or breast-feeding.

In the opinion of the principal investigator, any other condition that will preclude participation in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-Label Treatment

Participants receive lorundrostat once daily for 52 weeks

52 weeks

Randomized Treatment Withdrawal (RTW) Substudy

Participants receive lorundrostat or placebo once daily for 4 weeks starting at week 12

4 weeks

Safety Follow-up

Participants are monitored for safety after the treatment period

2 weeks

Optional Continuation Period

Participants may continue receiving lorundrostat until marketing authorization or early termination of the trial

What Are the Treatments Tested in This Trial?

Interventions

• Lorundrostat

Trial Overview The trial is testing the long-term effects of lorundrostat on people with high blood pressure. It aims to assess how safe and effective it is over time compared to a placebo (a substance with no active drug).

How Is the Trial Designed?

Group I: RTW Substudy Experimental Treatment 2 Interventions

lorundrostat or placebo once daily for 4 weeks starting at week 12, in the double-blind randomized treatment withdrawal substudy Optional for subjects from the MLS-101-301 parent study only

Group II: Optional Continuation Period Experimental Treatment 1 Intervention

lorundrostat once daily from week 52 or until marketing authorization or early termination of the trial by the sponsor

Group III: Open-Label Arm Experimental Treatment 1 Intervention

lorundrostat once daily for 52 weeks depending on when the subject enrolled

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. jamanetwork.com jamanetwork.com/journals/jama/article-abstract/2835763

Lorundrostat in Participants With Uncontrolled ... This randomized clinical trial compares the efficacy and safety of lorundrostat for lowering blood pressure when added to a prescribed