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Efficacy and Safety of Lorundrostat in Subjects with Uncontrolled and Resistant Hypertension

PHASE3RECRUITING

This is a Phase 3 trial to evaluate the BP-lowering effect of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive (AHT) medications.

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Study details:

This study is a Phase 3 trial to evaluate the BP-lowering effect of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive (AHT) medications, one of which must be a thiazide or thiazide-like diuretic. The study consists of a 2-week screening period with a 2-week single-blind run-in period followed by a 12-week randomized, double-blind, placebo-controlled, parallel arm period. Following the randomized period subjects will be offered an opportunity to participate in an open-label extension (OLE) study.

Any subject electing to not participate in the OLE will undergo an end of study (EoS) visit, which will occur after end of treatment (EoT), to complete their participation in the study.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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

Taking between 2 and 5 AHT medications

History of hypertension lasting at least 6 months prior to Screening

Body mass index (BMI) of ≥18 kg/m2 at Screening

Exclusion criteria

Women who are pregnant, plan to become pregnant, or are breastfeeding

Participation in a study involving any investigational device or small-molecule drug within 4 weeks or 6 months for biologic (antibody) drugs prior to the Screening Visit

eGFR <45 mL/min/1.73m2 at Screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula

Serum potassium >5.0 mmol/L at Screening or >4.8 mmol/L at Randomization

Serum sodium <135 mmol/L (corrected for hyperglycemia) at Screening.

History of heart failure, myocardial infarction, stroke, or transient ischemic attack within 6 months prior to the Screening Visit.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-11-22

Primary completion: 2025-02-01

Study completion finish: 2025-07-01

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT06153693

Intervention or treatment

DRUG: Placebo

DRUG: lorundrostat Dose 1

DRUG: lorundrostat Dose 2

Conditions

• Hypertension

Condition: Hypertension
DRUG: Placebo and other drugs
Hobart, Tasmania, Australia and more
Sponsor: Mineralys Therapeutics Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Royal Hobart Hospital

Research sites nearby

Select from list below to view details:

Royal Hobart Hospital
Hobart, Tasmania, Australia
Castle Hill Medical Centre
Castle Hill, New South Wales, Australia
Renal Research - Gosford
Gosford, New South Wales, Australia
University of Newcastle - John Hunter Hospital (JHH)
Waratah, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
PLACEBO_COMPARATOR: Placebo Placebo once daily (QD) for 12 weeks	DRUG: Placebo Placebo once daily (QD) for 12 weeks
EXPERIMENTAL: Dose 1 50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks	DRUG: lorundrostat Dose 1 50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks
EXPERIMENTAL: Dose 2 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	DRUG: lorundrostat Dose 2 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

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Change from baseline in automated office BP (AOBP) SBP at Week 6 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo	Not Specified	Week 6

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Proportion of subjects with AOBP SBP <130 mmHg at Week 6 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo	Not Specified	Week 6
Change from baseline in AOBP SBP at Week 12 in subjects randomized to lorundrostat 50 mg QD with escalation to lorundrostat 100 mg QD compared to subjects randomized to placebo	Not Specified	Week 12
Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 2 prescribed AHT medications	Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 2 prescribed AHT medications randomized to lorundrostat 50 mg QD compared to subjects with uncontrolled hypertension on 2 prescribed AHT medications randomized to placebo	Week 6
Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 3 or more prescribed AHT medications	Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 3 or more prescribed AHT medications (resistant hypertension) randomized to lorundrostat 50 mg QD compared to subjects with uncontrolled hypertension on 3 or more prescribed AHT medications (resistant hypertension) randomized to placebo	Week 6
Change from baseline in AOBP SBP at Week 6 by obesity status in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo	Not Specified	Week 6
Change from baseline in AOBP SBP at Week 12 in subjects who were escalated to lorundrostat 100 mg QD at week 6 (within-subjects analysis)	Not Specified	Week 12

Frequently Asked Questions

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References

Clinical Trials Gov: Efficacy and Safety of Lorundrostat in Subjects with Uncontrolled and Resistant Hypertension