Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

MLS-101-301: A Randomized, Double-Blind, Placebo Controlled, Parallel Arm, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Lorundrostat in Subjects with Uncontrolled and Resistant Hypertension

This research is investigating a new medication, lorundrostat, for individuals whose high blood pressure (hypertension) remains high despite taking their usual medicines. It's a Phase 3 study, meaning it's in the later stages of testing and aims to confirm if the drug works well and is safe. Participants will be given either lorundrostat or a placebo (a dummy pill with no active medicine) without knowing which they receive. The main goal is to check how much lorundrostat lowers blood pressure compared to the placebo after six weeks. Researchers will also look at safety and other effects over twelve weeks. The study includes adults aged 18 and over, both men and women, with uncontrolled or resistant high blood pressure.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Mineralys Therapeutics Inc.

Enrolment target

420

Start

08 Apr 2024

Uncontrolled and Resistant Hypertension

What is this study about?

This study is exploring a new medicine called lorundrostat, which is designed to help people with high blood pressure that hasn't responded well to their current treatments. This type of high blood pressure is sometimes called 'uncontrolled' or 'resistant' hypertension. It's a big problem because high blood pressure can lead to serious health issues like heart attacks and strokes if not managed properly. The aim of this research is to see if lorundrostat can be a new, effective, and safe option for these patients.

Imagine you have high blood pressure, and even with the medicines you're taking, it's still too high. This study wants to find out if adding lorundrostat to your treatment plan could make a real difference. Participants in the study will be divided into groups. Some will receive the new medicine, lorundrostat, while others will get a placebo, which looks just like the study drug but doesn't contain any active medication. Neither you nor your study doctor will know which one you are taking; this helps ensure the results are as fair and unbiased as possible.

The main thing the researchers want to measure is how much your blood pressure changes after six weeks of taking either lorundrostat or the placebo. They'll specifically look at your 'systolic' blood pressure (the top number in a blood pressure reading, like 120 over 80). They'll also follow participants for up to 12 weeks to see if the medicine continues to work, if a higher dose is better for some, and to keep an eye on any side effects. This research is crucial for potentially finding new ways to help people whose high blood pressure is difficult to control.

Key takeaways

This study is testing a new drug, lorundrostat, for people with difficult-to-control high blood pressure.
It aims to see if lorundrostat can lower blood pressure more than a dummy pill (placebo).
Participants will receive either lorundrostat or a placebo, and neither they nor their doctor will know which.
The main goal is to measure blood pressure changes after 6 weeks of treatment.
The study lasts about 12 weeks in total, with regular check-ups.
Active participation can help potentially find new ways to treat stubborn high blood pressure.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

The most important health requirement is that you have high blood pressure (hypertension) that is not currently well-controlled by your existing medications. This means your blood pressure is still too high even though you're taking medicine for it. Some people in the study will have 'uncontrolled hypertension,' meaning their blood pressure isn't at target despite treatment. Others will have 'resistant hypertension,' which means their blood pressure is still high even when they're taking three or more different blood pressure medicines, including one that works by getting rid of excess salt and water (a diuretic).

There might be other specific health conditions or medications that would prevent you from taking part, to ensure the study is safe and that results are clear. Your study doctor can check all these details with you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have high blood pressure that is not well-controlled by your current medicines?
Are you male or female?
Are you able to attend regular clinic appointments for blood pressure checks and health monitoring?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the study medicine (lorundrostat) or a placebo (a dummy pill) to take regularly. You won't know which one you're getting, and neither will your study doctor. You'll have regular visits to the clinic, where your blood pressure will be measured carefully using an automated machine in the office. These measurements will help the study team see how your blood pressure is changing.

Your blood pressure will be measured at the beginning of the study to get a starting point. Then, key measurements will be taken at 6 weeks and 12 weeks to see how the treatment is working. Throughout the study, the team will also monitor your general health and check for any side effects. In some cases, if your blood pressure still isn't at target after 6 weeks, your dose of lorundrostat might be increased if you are in that treatment group. The total duration of active participation in the study will usually be about 12 weeks, including follow-up assessments.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of joining this study is that the new medicine, lorundrostat, might help lower your high blood pressure more effectively than your current treatments, which could improve your future health. You would also receive close medical attention and monitoring throughout the study. However, there's no guarantee the medicine will work for you, and you might receive the placebo. Potential risks could include side effects from the study medication, though these will be carefully monitored. You will be told about all known potential side effects before you decide to join. It is very important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Poland
—
Unverified
France
—
Unverified
Spain
—
Unverified
Italy
—
Unverified
Netherlands
—
Unverified
Bulgaria
—
Unverified
Germany
—
Unverified
Romania

Common questions

What is high blood pressure and why is it important to control?

High blood pressure means the force of your blood pushing against your artery walls is consistently too high. Over time, this can damage your heart and blood vessels, increasing your risk of heart attack, stroke, and kidney disease. Controlling it helps protect your health.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks exactly like the study medicine but doesn't contain any active drug. It's used in studies to compare the new medicine's effects against doing nothing, helping researchers understand if the new drug truly works.

What does 'uncontrolled hypertension' mean?

This means your blood pressure is still higher than recommended levels, even though you are already taking medication for it.

What is 'resistant hypertension'?

This is a type of uncontrolled high blood pressure where your blood pressure remains high despite taking three or more different blood pressure medications, including one that helps remove excess fluid.

Will I know if I'm getting the real medicine or the placebo?

No, you won't. This is called a 'double-blind' study, meaning neither you nor your study doctor will know who is receiving the active drug and who is receiving the placebo. This helps make the study results more reliable.