> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-pivotal-study-to-evaluate-the-efficacy-of-lorundrostat-in-3e37ddcd-b83d-445c-9ce0-2e7d28292cf5 > Record changed: 2026-10-13 # A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects With Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen NCT05769608 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) Participants 285 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) Lead sponsor Mineralys Therapeutics Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) Start date 2023-03-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) Number of sites 104 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) ## Title and summary **Summary** A Phase 2 trial to evaluate the blood pressure-lowering effect of lorundrostat an aldosterone synthase inhibitor (ASI), administered as an add-on to a standardized anti-hypertensive (AHT) medication regimen, in subjects with hypertension. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) **Short title** A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects With Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) ## Dates **Completion date** 2025-01-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) **First posted** 2023-03-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) **Registry last updated** 2026-01-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) **Primary completion date** 2025-01-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) **Start date** 2023-03-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) ## Size and sites **Actual participants** 285 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) **Participants** 285 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) **Protocol amendments** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) **Number of sites** 104 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) **Lead sponsor** Mineralys Therapeutics Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) ## Identifiers **Registry ID** NCT05769608 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) **ClinicalTrials.gov ID** NCT05769608 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Care providers Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) ## Outcomes ### Primary outcomes 1. Change in 24-hour average ambulatory blood pressure monitoring (ABPM) systolic blood pressure (SBP) Timeframe: Baseline (Randomization) to Week 12 ### Secondary outcomes 1. Change from baseline in 24-hour average ABPM SBP at Week 4 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo Timeframe: Baseline to Week 4 2. Proportion of subjects with 24-hour average ABPM SBP <125 mmHg at Week 4 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo Timeframe: at Week 4 3. Change from baseline in 24-hour average ABPM SBP at Week 4 by obesity status in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo Timeframe: Baseline to Week 4 4. Change from baseline in automated office BP (AOBP) SBP at Week 12 in subjects who were escalated to lorundrostat 100 mg QD at Week 4 (within-subjects analysis) Timeframe: Baseline to Week 12 5. Change from baseline in 24-hour average ABPM SBP at Week 4, by number of AHT medications in the standardized AHT regimen (2 and 3) in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo Timeframe: Baseline to Week 4 6. Proportion of subjects with 24-hour average ABPM SBP <125 mmHg at Week 12 in subjects randomized to lorundrostat (by arm and pooled dosages) compared to subjects randomized to placebo Timeframe: Baseline to Week 12 7. Change from baseline in 24-hour average ABPM SBP at Week 12 by obesity status in subjects randomized to lorundrostat (by arm and pooled dosages) compared to subjects randomized to placebo Timeframe: Baseline to Week 12 8. Change from baseline in daytime average ABPM SBP at Week 4 and Week 12 in subjects randomized to lorundrostat 50 mg (Week 4) and by arm and pooled dosages (Week 12) compared to subjects randomized to placebo Timeframe: Baseline to Week 4 and Week 12 9. Change from baseline in AOBP SBP at Week 4 and Week 12 in subjects randomized to lorundrostat 50 mg QD (Week 4) and by arm and pooled dosages (Week 12) compared to subjects randomized to placebo Timeframe: Baseline to Week 4 and Week 12 10. Change from baseline in nighttime average ABPM SBP at Week 4 and Week 12 in subjects randomized to lorundrostat 50 mg QD (Week 4) and by arm and pooled dosages (Week 12) compared to subjects randomized to placebo Timeframe: Baseline to Week 4 and Week 12 11. Change from baseline in 24-hour average ABPM SBP at Week 12, in subjects randomized to lorundrostat (pooled dosages) compared to subjects randomized to placebo Timeframe: Baseline to Week 12 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) ## 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 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) ## Sites - Cardiology, P.C. - BirminghamBirmingham, United States - University of Alabama at Birmingham (UAB) - Vascular Biology and Hypertension ProgramBirmingham, United States - Chandler Clinical TrialsChandler, United States - Brown Road Family MedicineMesa, United States - Scottsdale Clinical Trials (Elite Clinical Network)Scottsdale, United States - Fiel Family & Sports MedicineTempe, United States - Noble Clinical ResearchTucson, United States - Del Sol Research Management, LLCTucson, United States - The Medical Research Group Inc.Fresno, United States - Marvel Clinical ResearchHuntington Beach, United States - University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI)La Jolla, United States - Clinical Trials ResearchLincoln, United States - Cedars-Sinai Medical CenterLos Angeles, United States - Catalina Research InstituteMontclair, United States - Northridge Clinical TrialsNorthridge, United States - University of California Irvine Medical CenterOrange, United States - Triwest Research AssociatesSan Diego, United States - San Jose Clinical TrialsSan Jose, United States - Blue Coast Research CenterVista, United States - Accelerated Enrollment Solutions (AES)- VistaVista, United States - Delta Waves, Inc.Colorado Springs, United States - CMR of Greater New HavenHamden, United States - Indago Research & Health Center, Inc.Hialeah, United States - Clinical Neuroscience Solutions, Inc (Jacksonville)Jacksonville, United States - Reserka, LLCMiami, United States And 79 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) ## References - PubMed 40267417 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40267417/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05769608) ## 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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