Lorundrostat for High Blood Pressure

Recruiting at 178 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

1400 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension

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.

How is the drug Lorundrostat different 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 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

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

Treatment Details

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).

Participant Groups

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

Findings from Research

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]

References

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

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

2. Switzerland pubmed.ncbi.nlm.nih.gov

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

3. 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]

4. 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]

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]