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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06153693
Registration number
NCT06153693
Ethics application status
Date submitted
17/11/2023
Date registered
1/12/2023
Date last updated
7/06/2024
Titles & IDs
Public title
Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension
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Scientific 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
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Secondary ID [1]
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MLS-101-301
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypertension
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Condition category
Condition code
Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - lorundrostat Dose 1
Treatment: Drugs - lorundrostat Dose 2
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
Treatment: Drugs: Placebo
Placebo once daily (QD) for 12 weeks
Treatment: Drugs: lorundrostat Dose 1
50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks
Treatment: Drugs: lorundrostat 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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline in automated office BP (AOBP) SBP at Week 12 in subjects randomized to lorundrostat
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Assessment method [1]
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Timepoint [1]
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Week 12
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Primary outcome [2]
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Change from baseline in AOBP SBP at Week 12 in subjects randomized to lorundrostat Dose 1 with escalation to lorundrostat Dose 2
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Assessment method [2]
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Timepoint [2]
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Week 12
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Secondary outcome [1]
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Proportion of subjects with AOBP SBP <130 mmHg at Week 12 in combined lorundrostat dosages
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Assessment method [1]
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Change from baseline in AOBP SBP at Week 12 in subjects with uncontrolled hypertension in combined lorundrostat dosages
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Assessment method [2]
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Change from baseline in AOBP SBP at Week 12 in subjects with resistant hypertension in combined lorundrostat dosages
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Assessment method [3]
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Change from baseline in AOBP SBP at Week 12 by obesity status in combined lorundrostat dosages
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Assessment method [4]
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Change from baseline in AOBP SBP at Week 12 in subjects who did not reach SBP control by Week 6 on lorundrostat Dose 1 and were increased to lorundrostat Dose 2 (within-subjects analysis)
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Assessment method [5]
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Timepoint [5]
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Week 12
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Eligibility
Key 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
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/11/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2025
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Actual
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Sample size
Target
1000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Castle Hill Medical Centre - Castle Hill
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Recruitment hospital [2]
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Renal Research - Gosford - Gosford
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University of the Sunshine Coast - Clinical Trials Centre - Sippy Downs
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AusTrials - Taringa - Taringa
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AusTrials - Wellers Hill - Taringa
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AusTrials - Sunshine - St Albans
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Recruitment postcode(s) [1]
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2154 - Castle Hill
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Recruitment postcode(s) [2]
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2250 - Gosford
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Recruitment postcode(s) [3]
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4556 - Sippy Downs
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Recruitment postcode(s) [4]
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4068 - Taringa
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Recruitment postcode(s) [5]
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VIC 3021 - St Albans
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
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Name
Mineralys Therapeutics Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06153693
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Contacts
Principal investigator
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Contact person for public queries
Name
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Efosa Eluma
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Address
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Phone
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+1-832-614-2778
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06153693
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