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

Purpose

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

  • Hypertension

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Alabama at Birmingham (UAB) - Vascular Biology and Hypertension Program
Birmingham, Alabama 35294
Contact:
Nicole Lohr
205-934-9166
nlohr@uabmc.edu

More Details

Status
Recruiting
Sponsor
Mineralys Therapeutics Inc.

Study Contact

Jessica Tesoriero
617-688-1437
jtesoriero@mineralystx.com

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.