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Aldosterone Synthase Inhibitor

Lorundrostat for High Blood Pressure

Verified Trial
Phase 2 & 3
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
[Randomized treatment withdrawal only] Taking an oral dose of lorundrostat of at least 25 mg once daily
At least 18 years of age at the time of signing the informed consent form Participation in a lorundrostat study with the option of transitioning to the OLE study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48 to week 52
Awards & highlights

Study Summary

This trial looks at whether a medication can safely and effectively control high blood pressure over time.

Who is the study for?
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.Check my eligibility
What is being tested?
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).See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with hypertension medications include dizziness, headaches, fatigue, and gastrointestinal issues. Lorundrostat may also have unique side effects due to its mechanism as an aldosterone synthase inhibitor.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently taking a daily oral dose of lorundrostat of at least 25 mg.
Select...
I am over 18 and may join a lorundrostat study or its ongoing extension.
Select...
I am currently taking a daily dose of lorundrostat of at least 25 mg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48 to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 to week 52 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 automated office blood pressure (AOBP) systolic blood pressure (SBP)
Secondary outcome measures
Change in AOBP DBP in subjects taking placebo at study entry
Change in AOBP SBP in subjects taking lorundrostat at study entry
Change in AOBP SBP in subjects taking placebo at study entry
+5 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Taper ArmExperimental Treatment2 Interventions
lorundrostat and/or placebo once daily for 4 weeks in the double-blind randomized treatment withdrawal sub-study
Group II: Open-Label ArmExperimental Treatment1 Intervention
lorundrostat once daily for 48 weeks
Group III: Maintenance ArmExperimental Treatment1 Intervention
lorundrostat once daily for 4 weeks in the double-blind randomized treatment withdrawal sub-study
Group IV: PlaceboPlacebo Group1 Intervention
Placebo once daily for 4 weeks in the double-blind randomized treatment withdrawal sub-study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Mineralys Therapeutics Inc.Lead Sponsor
4 Previous Clinical Trials
1,580 Total Patients Enrolled

Media Library

Lorundrostat (Aldosterone Synthase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05968430 — Phase 2 & 3
High Blood Pressure Research Study Groups: Open-Label Arm, Maintenance Arm, Taper Arm, Placebo
High Blood Pressure Clinical Trial 2023: Lorundrostat Highlights & Side Effects. Trial Name: NCT05968430 — Phase 2 & 3
Lorundrostat (Aldosterone Synthase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05968430 — Phase 2 & 3

Frequently Asked Questions

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

Are there still opportunities for participants in this research protocol?

"Absolutely. Clinicaltrials.gov states that this clinical trial is currently in search of participants, with the first posting on March 6th 2023 and last edited on August 2nd 2023. To date, 900 individuals must be recruited from one medical facility."

Answered by AI

How many volunteers have registered for the study thus far?

"Indeed, the clinicaltrial.gov platform confirms that this medical trial is currently seeking participants. It was first established on March 6th 2023 and has been revised most recently on August 2nd 2023. This study needs to enroll 900 patients at a single site."

Answered by AI

Who else is applying?

What site did they apply to?
CMR of Greater New Haven
Burke Internal Medicine
Juno Research, LLC
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

I have high blood pressure. I want a better solution for high blood pressure.
PatientReceived no prior treatments
My hypertension is resistant to current treatments and I'm only 39, but would love to live to see 50.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Open-Label Extension Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Uncontrolled Hypertension
2023. "Open-Label Extension Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Uncontrolled Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05968430.
All > Tucson
~600 spots leftby Dec 2025
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