> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-of-lorundrostat-in-subjects-with-da242d34-f2d5-43ce-ae57-e27f7924b996 > Record changed: 2026-10-13 # Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension NCT06153693 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) Participants 1,083 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) Lead sponsor Mineralys Therapeutics Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) Start date 2023-11-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) Number of sites 184 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) **Short title** Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) ## Dates **Completion date** 2025-01-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) **First posted** 2023-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) **Registry last updated** 2026-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) **Primary completion date** 2024-12-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) **Start date** 2023-11-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) ## Size and sites **Actual participants** 1,083 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) **Participants** 1,083 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) **Number of sites** 184 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) **Lead sponsor** Mineralys Therapeutics Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) ## Identifiers **Registry ID** NCT06153693 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) **ClinicalTrials.gov ID** NCT06153693 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) ## Outcomes ### Primary outcomes 1. 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 Timeframe: Week 6 ### Secondary outcomes 1. 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 Timeframe: Week 6 2. 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 Timeframe: Week 12 3. Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 2 prescribed AHT medications Timeframe: Week 6 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 4. Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 3 or more prescribed AHT medications Timeframe: Week 6 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 5. 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 Timeframe: Week 6 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) Timeframe: Week 12 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) ## Sites - Advanced Cardiovascular, LLC - Alexander City OfficeAlexander City, United States - Central Research Associates, IncBirmingham, United States - Cardiology, P.C.Birmingham, United States - Synexus (Radiant Research, Inc) - Alabama - Simon Williamson Clinic LocationBirmingham, United States - G & L Research LLC - FoleyFoley, United States - Accel Research Sites (ARS) - Birmingham Clinical Research UnitVestavia Hills, United States - Del Sol ResearchTucson, United States - Entertainment Medical Group, Inc.Beverly Hills, United States - Amicis Research Center - Granada HillsGranada Hills, United States - Amicis Research Center - NorthridgeGranada Hills, United States - Marvel Clinical Research, LLCHuntington Beach, United States - Amicis Research CenterNorthridge, United States - Pasadena Clinical TrialsPasadena, United States - Empire Clinical Research (ECR)Pomona, United States - Clinical Trials Research (CTR) - SacramentoSacramento, United States - North America Research InstituteSan Dimas, United States - Amicis Research Center - ValenciaValencia, United States - CMR of Greater New HavenHamden, United States - Chase Medical Research, LLC - HamdenWaterbury, United States - Indago Research and Health CenterHialeah, United States - Clinical Neuroscience Solutions (CNS Healthcare) - JacksonvilleJacksonville, United States - Nuovida Research Center CorpMiami, United States - Clinical Neuroscience Solutions (CNS Healthcare) - Orlando Research CenterOrlando, United States - AES OrlandoOrlando, United States - Patron Medical - Andres Patron D.O. (Patron Ventures, LLC)Pembroke Pines, United States And 159 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) ## References - PubMed 40587141 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40587141/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06153693) ## Related records ### Drugs (1) - [Lorundrostat](https://trialight.com/data/asset/lorundrostat-c0863b53-0f6c-4044-b54f-78bf207c9c16.md) ### Lead sponsors (1) - [Mineralys Therapeutics Inc.](https://trialight.com/data/company/mineralys-therapeutics-inc-2ef4e012-fde3-4ebc-a266-37dc2b7710e1.md) ### Conditions (1) - [Hypertensive disorder](https://trialight.com/data/condition/hypertensive-disorder-6d786557-b9e8-5afc-80f3-89a1995f9da5.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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