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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
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
Secondary ID [1] 0 0
MLS-101-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in automated office BP (AOBP) SBP at Week 12 in subjects randomized to lorundrostat
Timepoint [1] 0 0
Week 12
Primary outcome [2] 0 0
Change from baseline in AOBP SBP at Week 12 in subjects randomized to lorundrostat Dose 1 with escalation to lorundrostat Dose 2
Timepoint [2] 0 0
Week 12
Secondary outcome [1] 0 0
Proportion of subjects with AOBP SBP <130 mmHg at Week 12 in combined lorundrostat dosages
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Change from baseline in AOBP SBP at Week 12 in subjects with uncontrolled hypertension in combined lorundrostat dosages
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Change from baseline in AOBP SBP at Week 12 in subjects with resistant hypertension in combined lorundrostat dosages
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Change from baseline in AOBP SBP at Week 12 by obesity status in combined lorundrostat dosages
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
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)
Timepoint [5] 0 0
Week 12

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Castle Hill Medical Centre - Castle Hill
Recruitment hospital [2] 0 0
Renal Research - Gosford - Gosford
Recruitment hospital [3] 0 0
University of the Sunshine Coast - Clinical Trials Centre - Sippy Downs
Recruitment hospital [4] 0 0
AusTrials - Taringa - Taringa
Recruitment hospital [5] 0 0
AusTrials - Wellers Hill - Taringa
Recruitment hospital [6] 0 0
AusTrials - Sunshine - St Albans
Recruitment postcode(s) [1] 0 0
2154 - Castle Hill
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [4] 0 0
4068 - Taringa
Recruitment postcode(s) [5] 0 0
VIC 3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
State/province [3] 0 0
California
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United States of America
State/province [4] 0 0
Connecticut
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United States of America
State/province [5] 0 0
Florida
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United States of America
State/province [6] 0 0
Georgia
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United States of America
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Idaho
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Illinois
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Indiana
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Kentucky
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Louisiana
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Massachusetts
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Mississippi
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Missouri
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Nebraska
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Nevada
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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Tennessee
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Texas
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Utah
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Virginia
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Bulgaria
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Gabrovo
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Bulgaria
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Pleven
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Bulgaria
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Sofia
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Bulgaria
State/province [29] 0 0
Veliko Tarnovo
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Canada
State/province [30] 0 0
Ontario
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Canada
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Quebec
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Germany
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Lower Saxony
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Germany
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Rhineland-Palatinate
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Germany
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Berlin
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Germany
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Deggingen
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Italy
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Brescia
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Italy
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Ferrara
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Italy
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Genova
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Italy
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Napoli
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Italy
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Rome
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Polska
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Lódz
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San Juan
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Timis
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Barcelona
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Córdoba
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Granada
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Spain
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Valencia
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Great Britain
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Aberdeen
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Canterbury
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Carshalton
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Glasgow
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United Kingdom
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Newquay

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Mineralys Therapeutics Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06153693
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Efosa Eluma
Address 0 0
Country 0 0
Phone 0 0
+1-832-614-2778
Fax 0 0
Email 0 0
eeluma@mineralystx.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06153693