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Aldosterone Synthase Inhibitor

Lorundrostat for High Blood Pressure

Verified Trial
Phase 2
Recruiting
Research Sponsored by Mineralys Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

Study Summary

This trial tests if a new drug can help lower high blood pressure, when taken with other medications.

Who is the study for?
This trial is for adults with a BMI of 18-40 who have high blood pressure not controlled by standard medications. It's not for those with recent serious cancers (except certain skin cancers), or people at risk if they stop their current heart meds. Also excluded are those with recent heart attacks, strokes, drug abuse, certain allergies, and conditions that could affect the study.Check my eligibility
What is being tested?
The trial tests lorundrostat at two different doses versus a placebo to see how well it lowers blood pressure when taken alongside usual hypertension drugs. Lorundrostat blocks aldosterone production which can contribute to high blood pressure.See study design
What are the potential side effects?
While specific side effects of lorundrostat aren't listed here, similar medications may cause dizziness due to low blood pressure, increased potassium levels in the blood, kidney issues, and hormonal imbalances.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 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 in 24-hour mean ambulatory blood pressure monitoring (ABPM) systolic blood pressure (SBP) from Week 0 (randomization) to Week 12
Secondary outcome measures
Change in 24-hour mean ABPM diastolic blood pressure (DBP)
Change in 24-hour mean central DBP
Change in 24-hour mean central SBP
+12 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Dose 2Experimental Treatment1 Intervention
lorundrostat Dose 1 once daily for 4 weeks then lorundrostat Dose 2 once daily for 8 weeks
Group II: Dose 1Experimental Treatment1 Intervention
lorundrostat Dose 1 once daily for 12 weeks
Group III: PlaceboPlacebo Group1 Intervention
Placebo once daily 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
2,180 Total Patients Enrolled

Media Library

Lorundrostat (Aldosterone Synthase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05769608 — Phase 2
High Blood Pressure Research Study Groups: Placebo, Dose 1, Dose 2
High Blood Pressure Clinical Trial 2023: Lorundrostat Highlights & Side Effects. Trial Name: NCT05769608 — Phase 2
Lorundrostat (Aldosterone Synthase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05769608 — Phase 2
High Blood Pressure Patient Testimony for trial: Trial Name: NCT05769608 — Phase 2

Frequently Asked Questions

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

Do the potential benefits of Dose 1 outweigh any possible risks to patients?

"The safety of Dose 1 was rated a 2 on the risk scale, as this is only Phase 2 trial and thus lacks evidence to support efficacy. However, there are some results that suggest it may be safe for general use."

Answered by AI

What is the maximum number of participants allowed in this research endeavor?

"Confirmed. Clinicaltrials.gov data attests to this medical research being active, which was first made available on March 1st 2023 and modified most recently on the 3rd of that same month. The trial is looking for 300 participants from just one site."

Answered by AI

Are any slots still available for eligible participants in this research endeavor?

"Affirmative. Per the information disseminated on clinicaltrials.gov, this trial is still actively seeking participants. It was initially posted on March 1st 2023 and it's most recent update occurred on March 3rd of that same year. The primary research objective requires 300 patients to be enrolled from a single healthcare facility."

Answered by AI

Who else is applying?

What state do they live in?
Other
Tennessee
Texas
Georgia
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
0
What site did they apply to?
Georgia Clinical Research, LLC
Randomize Now
Quality Clinical Research Inc. (QCR) - Omaha
Other

Why did patients apply to this trial?

Adress medical condition. I want to resolve my high bp. Because I have high blood pressure.
PatientReceived 2+ prior treatments
I need to find a new BP med thank you. I've tried other meds that don't work.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. GenHarp Clinical Solutions: < 48 hours
  2. Eagle Clinical Research: < 48 hours
  3. Clinical Research of West Florida: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects With Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen
2023. "A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects With Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05769608.
All > Fargo
~144 spots leftby Apr 2025
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