This clinical trial is focused on studying a condition known as Uncontrolled and Resistant Hypertension, which is a type of high blood pressure that remains high despite treatment with multiple medications. The trial will evaluate a new treatment called Lorundrostat, also known by its code name MLS-101. Lorundrostat is taken in the form of a tablet and is being tested to see how well it works and how safe it is for people with this type of high blood pressure.
The purpose of the study is to assess the effect of Lorundrostat when added to the current prescribed blood pressure medications. Participants in the study will be randomly assigned to receive either Lorundrostat or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for several weeks, during which participants will take the medication daily and attend regular check-ups to monitor their blood pressure and overall health.
Throughout the study, the dosage of Lorundrostat may be adjusted based on the participant’s response. The trial aims to determine if Lorundrostat can effectively lower blood pressure in people who have not had success with other treatments. This research is important for finding new ways to manage high blood pressure that is difficult to control with existing medications.
1joining the study
Upon joining the study, the participant will be required to provide written informed consent. This is a formal agreement to participate in the study after understanding all the details and implications.
The participant must be at least 18 years old and have a history of hypertension for at least six months.
2screening and randomization
During the screening phase, blood pressure will be measured to ensure it falls within the specified range. The participant must be taking between 2 and 5 antihypertensive medications, including a thiazide or thiazide-like diuretic, unless otherwise advised.
A blood sample will be taken in the morning to measure serum cortisol levels. Body mass index and arm circumference will also be assessed.
3run-in period
The participant will continue their current medication regimen, ensuring stability before the randomization visit. Adjustments may be made to include a thiazide or thiazide-like diuretic if not already part of the regimen.
4treatment phase
Participants will be randomly assigned to receive either lorundrostat 50 mg once daily or a placebo. This phase will last for 6 weeks.
At Week 6, blood pressure will be measured to assess changes from the baseline.
5dose escalation
For participants who continue in the study, the dose of lorundrostat may be increased to 100 mg once daily after Week 6, based on the study protocol.
The treatment will continue for an additional 6 weeks, with further assessments at Week 12.
6end of study
The study is expected to conclude by April 2025. Participants will have their final assessments and will be informed about the outcomes of their participation.
Who Can Join the Study?
You must provide written informed consent before any study-related activities begin. This means you agree to participate after understanding the study details.
You need to be at least 18 years old and able to give informed consent.
Your blood pressure should be within a specific range when measured at the clinic. The top number (systolic) should be between 135 and 180, and the bottom number (diastolic) should be between 65 and 110.
You should be taking between 2 and 5 blood pressure medications, and one of them must be a type called thiazide or thiazide-like diuretic. These medications should be at a stable dose for at least one month before the study starts.
You should have had high blood pressure for at least 6 months before the study begins.
Your morning blood test for cortisol, a hormone, should show levels between 3 and 22 micrograms per deciliter.
Your body mass index (BMI), which is a measure of body fat based on height and weight, should be 18 or higher.
Your arm circumference should be less than 52 centimeters.
If you are a fertile male or a female who can have children, you and your partner must agree to use effective birth control methods during the study and for 28 days after the last dose of the study drug.
You must be willing and able to follow the study instructions and attend all scheduled visits.
Who Cannot Join the Study?
Patients with uncontrolled and resistant hypertension cannot participate. This means their high blood pressure is not being managed well, even with treatment.
Patients who are not within the specified age range for the study cannot participate. The study is looking for specific age groups.
Patients who are part of a vulnerable population may not be eligible. This refers to groups of people who might need special protection or care.
Lorundrostat is a medication being studied for its ability to help control high blood pressure in people whose hypertension is not well managed with other treatments. It is being tested to see how effective and safe it is when added to the patient’s current blood pressure medications.
Uncontrolled Hypertension – This condition occurs when blood pressure remains above the target level despite the use of medication. It is characterized by consistently high readings, which can lead to damage in blood vessels and organs over time. The progression involves persistent elevation of blood pressure, which may require adjustments in medication or lifestyle changes to manage effectively.
Resistant Hypertension – This is a form of high blood pressure that remains elevated despite the use of three or more antihypertensive medications, including a diuretic. It indicates a more severe form of hypertension that is difficult to control. The condition progresses with sustained high blood pressure levels, which can increase the risk of cardiovascular complications if not managed properly.
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