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A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects With Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen

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ClinicalTrials.gov Identifier: NCT05769608
Recruitment Status : Recruiting
First Posted : March 15, 2023
Last Update Posted : April 26, 2024
Sponsor:
Information provided by (Responsible Party):
Mineralys Therapeutics Inc.

Study Description
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Brief Summary:
a Phase 2 trial to evaluate the blood pressure-lowering effect of lorundrostat (an aldosterone synthase inhibitor), administered on a background of a standardized anti-hypertensive (AHT) medication regimen, in subjects with uncontrolled and/or treatment-resistant hypertension.

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

Detailed Description:

This study is a Phase 2 trial to evaluate the blood pressure-lowering effects of lorundrostat (an aldosterone synthase inhibitor), administered on a background of a standardized anti-hypertensive (AHT) medication regimen, in subjects with uncontrolled and/or treatment-resistant hypertension.

The study consists of a standardized AHT regimen run-in phase followed by a randomized, double-blind, placebo-controlled, parallel arm phase, after which subjects will enter a washout period ending with an end of study (EoS) visit. Subjects may be offered the opportunity to participate in an open-label extension (OLE). Any subject electing to not participate in the OLE will undergo an end of study (EoS) visit to complete their participation in the study.

The study will be conducted at approximately 75-100 sites across the United States.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 261 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 2 Study to Evaluate the Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled Hypertension on a Standardized Medication Regimen
Actual Study Start Date : March 13, 2023
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : October 2024

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 for 12 weeks
 Drug: Placebo
Placebo once daily for 12 weeks
Experimental: Dose 1
lorundrostat Dose 1 once daily for 12 weeks
 Drug: lorundrostat Dose 1
lorundrostat Dose 1 once daily for 12 weeks
Experimental: Dose 2
lorundrostat Dose 1 once daily for 4 weeks then lorundrostat Dose 2 once daily for 8 weeks
 Drug: lorundrostat Dose 2
lorundrostat Dose 1 once daily for 4 weeks then lorundrostat Dose 2 once daily for 8 weeks for subjects who meet prespecified criteria


Outcome Measures
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Primary Outcome Measures :
  1. Change in 24-hour average ambulatory blood pressure monitoring (ABPM) systolic blood pressure (SBP [ Time Frame: Baseline (Randomization) to Week 12 ]

Secondary Outcome Measures :
  1. Change in 24-hour average ABPM SBP from baseline to Week 12, by body mass index (BMI) [ Time Frame: Baseline to Week 12 ]
  2. Proportion of subjects with 24-hour average ABPM SBP <125 mmHg [ Time Frame: at Week 12 ]
  3. Change in daytime average ABPM SBP [ Time Frame: Baseline to Week 12 ]
  4. Change in automated office blood pressure (AOBP) SBP [ Time Frame: Baseline to Week 12 ]
  5. Change in nighttime average ABPM SBP [ Time Frame: Baseline to Week 12 ]
  6. Change in AOBP SBP [ Time Frame: Baseline to Week 16 ]
  7. Change in 24-hour average ABPM SBP from baseline to Week 12, by number of AHT medications in the standardized AHT regimen (2 vs 3) [ Time Frame: Baseline to 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
  2. At Screening: AOBP SBP of 140-180 mmHg and AOBP DBP of 65-110 mmHg, or AOBP DBP of 90-110 mmHg
  3. 24-hour average ABPM SBP of 130-180 mmHg or 24-hour average ABPM DBP >80 mmHg
  4. Taking between 2 and 5 AHT medications, inclusive, at Screening visit.
  5. BMI of 18-40 kg/m2 inclusive at Screening

Exclusion Criteria:

  1. eGFR <45 mL/min/1.73 m2 at Screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
  2. Serum potassium >5.0 mmol/L at Screening or >4.8 mmol/L at Randomization
  3. Serum sodium <135 mmol/L at Screening
  4. History of heart failure, myocardial infarction, stroke, or transient ischemic attack within 6 months prior to Screening.
  5. Diabetes mellitus with a glycosylated hemoglobin (HbA1c) >9% (>74.9 mmol/mol) at Screening
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): NCT05769608


Contacts
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Contact: Megan McCormick 518-727-1995 mmccormick@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: NCT05769608    
Other Study ID Numbers: MLS-101-202
First Posted: March 15, 2023    Key Record Dates
Last Update Posted: April 26, 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
Uncontrolled hypertension
Hypertension
Hypertensive
Resistant hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases