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Aldosterone Synthase Inhibitor

Dose 2 for High Blood Pressure

Verified Trial
Phase 3
Waitlist Available
Research Sponsored by Mineralys Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years of age at the time of signing the informed consent form (ICF)
At Screening and Randomization: AOBP SBP of ≥135 and ≤180 mmHg plus AOBP DBP of ≥65 and ≤110 mmHg, or AOBP DBP of ≥90 and ≤110 mmHg
Must not have
Any hospitalizations to treat severely elevated blood pressure in the last year?
Any current or known nervous system conditions? (ex. Alzheimers, cerebral palsy, epilepsy, MS, and Parkinson's)
Timeline
Screening 4 weeks
Treatment 12 weeks
Follow Up 2 weeks
Awards & highlights

Study Summary

This trial will test if a new drug can lower blood pressure in people who take multiple medications but still have uncontrolled hypertension.

Who is the study for?
This trial is for adults over 18 with uncontrolled and resistant high blood pressure, despite taking 2-5 blood pressure medications. Participants must have a history of hypertension for at least 6 months, an office-based blood pressure reading within certain ranges, and a BMI of ≥18 kg/m2.Check my eligibility
What is being tested?
The trial is testing the effectiveness of lorundrostat at two different doses compared to a placebo in lowering blood pressure. Lorundrostat is an aldosterone synthase inhibitor. This Phase 3 study involves patients who are already on multiple anti-hypertensive drugs.See study design
What are the potential side effects?
While specific side effects for lorundrostat aren't listed here, common side effects for this type of medication may include dizziness, headache, fatigue, gastrointestinal issues or electrolyte imbalances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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Your blood pressure at screening and randomization should be between 135/65 and 180/110, or your diastolic blood pressure should be between 90 and 110.
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I have had high blood pressure for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 4 weeks
Treatment ~ 12 weeks
Follow Up ~2 weeks
This trial's timeline: 4 weeks for screening, 12 weeks for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in AOBP SBP at Week 12 in subjects randomized to lorundrostat Dose 1 with escalation to lorundrostat Dose 2
Change from baseline in automated office BP (AOBP) SBP at Week 12 in subjects randomized to lorundrostat
Secondary outcome measures
Change from baseline in AOBP SBP at Week 12 by obesity status in combined lorundrostat dosages
Change from baseline in AOBP SBP at Week 12 in subjects who did not reach SBP control by Week 6 on lorundrostat Dose 1 and were increased to lorundrostat Dose 2 (within-subjects analysis)
Change from baseline in AOBP SBP at Week 12 in subjects with resistant hypertension in combined lorundrostat dosages
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Dose 2Experimental Treatment1 Intervention
50 mg lorundrostat Dose 1 once daily (QD) for 6 weeks then 100 mg lorundrostat Dose 2 once daily (QD) for 6 weeks for subjects who meet prespecified criteria
Group II: Dose 1Experimental Treatment1 Intervention
50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks
Group III: PlaceboPlacebo Group1 Intervention
Placebo once daily (QD) for 12 weeks

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Mineralys Therapeutics Inc.Lead Sponsor
4 Previous Clinical Trials
1,480 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What repercussions have been observed for those taking Dose 1?

"Our team has appraised the safety of Dose 1 with a score of 3 due to prior clinical evidence pointing to efficacy and multiple evaluations verifying its security."

Answered by AI

At what locations are the protocols for this trial being implemented?

"This medical study is currently enrolling at 6 sites, three of which are in Hamden, Methuen and Canton. To reduce the amount of travel necessary when participating in this trial, it's recommended to choose a nearby location for enrollment."

Answered by AI

Are there any openings remaining for this experiment?

"Evidenced by its clinicaltrials.gov listing, this medical trial is not accepting participants at the moment. The experiment was initially published on December 1st 2023 and received an update 7 days later. Nevertheless, there are still 742 other studies that need patients to join right now."

Answered by AI

Who else is applying?

What site did they apply to?
Other
Synergy Groups Medical
Clinical Research of West Florida
Quality Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

Haven't found a medicine I can take. I would like my condition to improve.
PatientReceived 2+ prior treatments
I was told I have pulmonary hypertension. I've tried another medicine and it is not working.
PatientReceived no prior treatments
I’d like to be on one drug. I am loosing weight to help.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Quality Clinical Research: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension
2023. "Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06153693.
~667 spots leftby Mar 2025
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