Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension

NCT06153693
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Participants
1,083
clinicaltrials.gov
Lead sponsor
Mineralys Therapeutics Inc.
clinicaltrials.gov
Start date
2023-11-22
clinicaltrials.gov
Number of sites
184
clinicaltrials.gov

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.
clinicaltrials.gov
Short title
Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension
clinicaltrials.gov
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
clinicaltrials.gov

Control arm
Placebo
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2025-01-24
clinicaltrials.gov
First posted
2023-12-01
clinicaltrials.gov
Registry last updated
2026-05-01
clinicaltrials.gov
Primary completion date
2024-12-10
clinicaltrials.gov
Start date
2023-11-22
clinicaltrials.gov

Actual participants
1,083
clinicaltrials.gov
Participants
1,083
clinicaltrials.gov
Participant count basis
Actual
clinicaltrials.gov
Protocol amendments
5
clinicaltrials.gov
Number of sites
184
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Mineralys Therapeutics Inc.
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06153693
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06153693
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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

  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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)