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

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ClinicalTrials.gov Identifier: NCT06153693
Recruitment Status : Recruiting
First Posted : December 1, 2023
Last Update Posted : April 25, 2024
Sponsor:
Information provided by (Responsible Party):
Mineralys Therapeutics Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Placebo Drug: lorundrostat Dose 1 Drug: lorundrostat Dose 2 Phase 3

Detailed Description:

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 a 2-week end of study (EoS) visit, which will occur after end of treatment (EoT), to complete their participation in the study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo Controlled, Parallel Arm, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension
Actual Study Start Date : November 22, 2023
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in automated office BP (AOBP) SBP at Week 12 in subjects randomized to lorundrostat [ Time Frame: Week 12 ]
  2. Change from baseline in AOBP SBP at Week 12 in subjects randomized to lorundrostat Dose 1 with escalation to lorundrostat Dose 2 [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Proportion of subjects with AOBP SBP <130 mmHg at Week 12 in combined lorundrostat dosages [ Time Frame: Week 12 ]
  2. Change from baseline in AOBP SBP at Week 12 in subjects with uncontrolled hypertension in combined lorundrostat dosages [ Time Frame: Week 12 ]
  3. Change from baseline in AOBP SBP at Week 12 in subjects with resistant hypertension in combined lorundrostat dosages [ Time Frame: Week 12 ]
  4. Change from baseline in AOBP SBP at Week 12 by obesity status in combined lorundrostat dosages [ Time Frame: Week 12 ]
  5. 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) [ Time Frame: Week 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. At least 18 years of age at the time of signing the informed consent form (ICF)
  2. 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
  3. Taking between 2 and 5 AHT medications,
  4. History of hypertension lasting at least 6 months prior to Screening
  5. Body mass index (BMI) of ≥18 kg/m2 at Screening

Exclusion Criteria:

  1. Women who are pregnant, plan to become pregnant, or are breastfeeding
  2. 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
  3. eGFR <45 mL/min/1.73m2 at Screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
  4. Serum potassium >5.0 mmol/L at Screening or >4.8 mmol/L at Randomization
  5. Serum sodium <135 mmol/L (corrected for hyperglycemia) at Screening.
  6. History of heart failure, myocardial infarction, stroke, or transient ischemic attack within 6 months prior to the Screening Visit.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06153693


Contacts
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Contact: Efosa Eluma +1-832-614-2778 eeluma@mineralystx.com
Contact: Judy Thuo +44 7802 799478 jthuo@mineralystx.com

Locations
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Sponsors and Collaborators
Mineralys Therapeutics Inc.
More Information
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Responsible Party: Mineralys Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT06153693    
Other Study ID Numbers: MLS-101-301
First Posted: December 1, 2023    Key Record Dates
Last Update Posted: April 25, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mineralys Therapeutics Inc.:
Blood pressure
Hypertension
Hypertensive
Resistant hypertension
Uncontrolled hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases