Efficacy and Safety of Lorundrostat in Subjects with Uncontrolled and Resistant Hypertension
Purpose
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
- Hypertension
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo |
Placebo once daily (QD) for 12 weeks |
|
|
Experimental 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 |
|
Recruiting Locations
New Orleans, Louisiana 70112-2600
More Details
- Status
- Recruiting
- Sponsor
- Mineralys Therapeutics Inc.
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 an end of study (EoS) visit, which will occur after end of treatment (EoT), to complete their participation in the study.