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A randomized, double-blind, placebo-controlled, dose-ranging, Phase II study to evaluate the safety, efficacy, and tolerability of MLS-101 in Subjects With Uncontrolled Hypertension
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (Part I) | Placebo Comparator | Placebo tablet(s) by mouth once or twice daily. |
|
| Dose 1 (Part I) | Experimental | MLS-101 tablet(s) by mouth once or twice daily. |
|
| Dose 2 (Part I) | Experimental | MLS-101 tablet(s) by mouth once or twice daily. |
|
| Dose 3 (Part I) | Experimental | MLS-101 tablet(s) by mouth once or twice daily. |
|
| Placebo (Part II) | Placebo Comparator | Placebo tablet(s) by mouth once daily. |
|
| Dose (Part II) | Experimental | MLS-101 tablet(s) by mouth once daily. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MLS-101 (Part I) | Drug | MLS-101 tablet(s) by mouth once or twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Office-measured Systolic Blood Pressure (SBP) at Study Week 8 Compared to Placebo | The primary outcome was defined as the change in office-measured (mean of last 2 of 5 unattended measurements using an automated oscillometric sphygmomanometer device after approximately 5 minutes of rest in the seated position) SBP from baseline to the end of Study Week 8. The primary efficacy analysis was performed using a mixed model repeated measures (MMRM) approach with defined fixed effects per the statistical analysis plan. A least-square estimate of the mean difference between each dose group and the placebo group is provided for Week 8. | 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean Systolic Blood Pressure (SBP) and Mean Diastolic Blood Pressure (DBP) From Baseline to End of Treatment (EoT) | The ABPM SBP was measured at baseline and EoT. Change in ABPM-derived mean SBP and DBP from baseline to EoT was analyzed using an ANCOVA with a term for treatment group and a baseline mean 24-hour value as a covariate. | 8 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
1. Concomitant use of epithelial sodium channel inhibitors or mineralocorticoid receptor antagonists
3. Subjects with hypokalemia
4. Subjects with hyperkalemia
5. Subjects with serum cortisol < 3 mcg/dL
6. Subjects with serum sodium < 135 mEq/L
7. Subjects with estimated glomerular filtration rate < 60 mL/min/1.73m2
8. Subjects with type 1 or uncontrolled (hemoglobin A1c ≥ 9%) type 2 diabetes mellitus
9. Subjects with body mass index > 40 kg/m2
10. Subjects with unstable angina
11. Subjects with SBP ≥ 175 mm Hg or DBP ≥ 100 mm Hg for Part 1 and SBP ≥ 160 mm Hg or DBP ≥ 100 mm Hg for Part 2 at Pre-Screening, Screening/Start of Placebo Run-in, or Randomization
12. Subjects with a decrease in SBP ≥ 20 mm Hg or DBP ≥ 10 mm Hg from sitting to standing position at screening
13. Subjects who, in the opinion of the investigator, have suspected nonadherence to antihypertensive treatment
14. Subjects who, in the opinion of the investigator, have any major medical illness or symptoms
15. Subjects who, in the opinion of the investigator, have any acute or chronic medical or psychiatric condition
16. Subjects undergoing treatment with any of the following medications:
Topical corticoids
Sympathomimetic decongestants
Theophylline
Phosphodiesterase type 5 inhibitors
NSAIDs
Intramuscular steroids
Estrogen
Cytochromes
Strong CYP3A and CYP3A4 inducers
17. Subjects with known hypersensitivity to MLS-101 or any of the excipients
18. Subjects who are night-shift workers
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 103 | Lincoln | California | 95648 | United States | ||
| Site 129 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37690061 | Derived | Laffin LJ, Rodman D, Luther JM, Vaidya A, Weir MR, Rajicic N, Slingsby BT, Nissen SE; Target-HTN Investigators. Aldosterone Synthase Inhibition With Lorundrostat for Uncontrolled Hypertension: The Target-HTN Randomized Clinical Trial. JAMA. 2023 Sep 26;330(12):1140-1150. doi: 10.1001/jama.2023.16029. |
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After successful screening, subjects with plasma renin activity (PRA) ≤1ng/mL/h began a single-blind (SB) run-in period of BID oral treatment with placebo (PBO) in Part 1, and subjects with PRA >1ng/mL/h began a SB QD oral treatment with PBO in Part 2, while continuing on stable doses of background AHT medications. Subjects returned 2 weeks later on Day 1, and those who continued to meet eligibility requirements were randomized in 1:1 fashion with PBO (Part 1), or 6:1 fashion with PBO (Part 2).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo - Part 1 | Participants received matching placebo, taken orally, for 8 weeks in Part 1 of the study |
| FG001 | Lorundrostat 12.5 mg BID - Part 1 | Participants received 12.5 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 7, 2022 | Oct 10, 2023 |
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| Placebo (Part I) | Other | Placebo tablet(s) by mouth once or twice daily. |
|
| Placebo (Part II) | Other | Placebo tablet(s) by mouth once daily. |
|
| MLS-101 (Part II) | Drug | MLS-101 tablet(s) by mouth once daily. |
|
| Week 8 Change From Baseline in Office-measured Diastolic Blood Pressure (DBP) | Change in office-measured (average of last 2 of 5 unattended measurements using an automated oscillometric sphygmomanometer device after approximately 5 minutes of rest in the seated position) DBP from baseline to the end of study at week 8. | 8 weeks |
| Number of Participants With Blood Pressure ≤ 130/80 mmHg at Week 8 | Each participant was assessed as a success if the Week 8 value for SBP was ≤130 mmHg and DBP ≤80 mmHg; subjects not meeting both these thresholds were assessed as a failure. Subjects missing an assessment at Week 8 or who received rescue medications were also considered failures. | 8 Weeks |
| Torrance |
| California |
| 90502 |
| United States |
| Site 135 | Tustin | California | 92780 | United States |
| Site 131 | Clearwater | Florida | 33765 | United States |
| Site 105 | Coral Gables | Florida | 33134 | United States |
| Site 108 | Greenacres City | Florida | 33467 | United States |
| Site 134 | Jupiter | Florida | 33458 | United States |
| Site 146 | Miami | Florida | 33126 | United States |
| Site 137 | Miami | Florida | 33135 | United States |
| Site 139 | Miami | Florida | 33135 | United States |
| Site 143 | Miami | Florida | 33144 | United States |
| Site 122 | Pembroke Pines | Florida | 33026 | United States |
| Site 102 | Tampa | Florida | 91303 | United States |
| Site 118 | Albany | Georgia | 31707 | United States |
| Site 109 | Fayetteville | Georgia | 30214 | United States |
| Site 125 | Lawrenceville | Georgia | 30044 | United States |
| Site 136 | Arlington Heights | Illinois | 60005 | United States |
| Site 138 | Bossier City | Louisiana | 71111 | United States |
| Site 154 | Hammond | Louisiana | 70403 | United States |
| Site 148 | Shreveport | Louisiana | 71105 | United States |
| Site 114 | Slidell | Louisiana | 70458 | United States |
| Site 116 | Jefferson City | Missouri | 65109 | United States |
| Site 121 | St Louis | Missouri | 63141 | United States |
| Site 123 | Las Vegas | Nevada | 89121 | United States |
| Site 141 | Jamaica | New York | 11432 | United States |
| Site 133 | Asheboro | North Carolina | 27203 | United States |
| Site 113 | Charlotte | North Carolina | 28210 | United States |
| Site 130 | Fayetteville | North Carolina | 28304 | United States |
| Site 140 | Greensboro | North Carolina | 27408 | United States |
| Site 104 | Morgantown | North Carolina | 28655 | United States |
| Site 150 | Raleigh | North Carolina | 27612 | United States |
| Site 153 | Cleveland | Ohio | 44195 | United States |
| Site 115 | Rapid City | South Dakota | 57702 | United States |
| Site 107 | Chattanooga | Tennessee | 37421 | United States |
| Site 120 | Kingsport | Tennessee | 37660 | United States |
| Site 152 | Nashville | Tennessee | 37232 | United States |
| Site 151 | Arlington | Texas | 76012 | United States |
| Site 145 | Cypress | Texas | 77429 | United States |
| Site 132 | Dallas | Texas | 75224 | United States |
| Site 124 | McKinney | Texas | 75071 | United States |
| Site 147 | Mesquite | Texas | 75149 | United States |
| Site 126 | Pearland | Texas | 77584 | United States |
| Site 128 | Richland Hills | Texas | 76180 | United States |
| Site 112 | Forest | Virginia | 24551 | United States |
| FG002 | Lorundrostat 25 mg BID - Part 1 | Participants received 25 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study |
| FG003 | Lorundrostat 12.5 mg QD - Part 1 | Participants received 12.5 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study |
| FG004 | Lorundrostat 50 mg QD - Part 1 | Participants received 50 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study |
| FG005 | Lorundrostat 100 mg QD - Part 1 | Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study |
| FG006 | Placebo - Part 2 | Participants received matching placebo, taken orally, for 8 weeks in Part 2 of the study |
| FG007 | Lorundrostat 100 mg QD - Part 2 | Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 2 of the study |
| COMPLETED |
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| NOT COMPLETED |
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The Baseline Analysis Population consisted of all randomized subjects. This analysis set was used for summaries of subject study disposition, with subjects analyzed according to the randomized study treatment group they were assigned to.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo - Part 1 | Participants received matching placebo, taken orally, for 8 weeks in Part 1 of the study |
| BG001 | Lorundrostat 12.5 mg BID - Part 1 | Participants received 12.5 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study |
| BG002 | Lorundrostat 25 mg BID - Part 1 | Participants received 25 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study |
| BG003 | Lorundrostat 12.5 mg QD - Part 1 | Participants received 12.5 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study |
| BG004 | Lorundrostat 50 mg QD - Part 1 | Participants received 50 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study |
| BG005 | Lorundrostat 100 mg QD - Part 1 | Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study |
| BG006 | Placebo - Part 2 | Participants received matching placebo, taken orally, for 8 weeks in Part 2 of the study |
| BG007 | Lorundrostat 100 mg QD - Part 2 | Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 2 of the study |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Seated Automated Office-measured Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
| |||||||||||||||
| Seated Automated Office-measured Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Office-measured Systolic Blood Pressure (SBP) at Study Week 8 Compared to Placebo | The primary outcome was defined as the change in office-measured (mean of last 2 of 5 unattended measurements using an automated oscillometric sphygmomanometer device after approximately 5 minutes of rest in the seated position) SBP from baseline to the end of Study Week 8. The primary efficacy analysis was performed using a mixed model repeated measures (MMRM) approach with defined fixed effects per the statistical analysis plan. A least-square estimate of the mean difference between each dose group and the placebo group is provided for Week 8. | The full analysis set included all randomized subjects who received at least 1 dose of randomized study treatment (lorundrostat or placebo). Subjects were analyzed according to the randomized study treatment group. Per the study SAP, modelled analysis comparisons for Part 2 were performed for 100 mg QD Part 2 vs 100mg QD Part 1, and not to Placebo - Part 2. Accordingly, while subjects were analyzed, modelled LSmeans for Placebo - Part 2 were not reported. | Posted | Least Squares Mean | Standard Error | mmHg | 8 Weeks |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean Systolic Blood Pressure (SBP) and Mean Diastolic Blood Pressure (DBP) From Baseline to End of Treatment (EoT) | The ABPM SBP was measured at baseline and EoT. Change in ABPM-derived mean SBP and DBP from baseline to EoT was analyzed using an ANCOVA with a term for treatment group and a baseline mean 24-hour value as a covariate. | The full analysis set included all randomized subjects who received at least 1 dose of randomized study treatment (lorundrostat or placebo). Subjects were analyzed according to the randomized study treatment group. Per the study SAP, modelled analysis comparisons for Part 2 were performed for 100 mg QD Part 2 vs 100mg QD Part 1, and not to Placebo - Part 2. Accordingly, while subjects were analyzed, modelled LSmeans for Placebo - Part 2 were not reported. | Posted | Least Squares Mean | Standard Error | mmHg | 8 Weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Week 8 Change From Baseline in Office-measured Diastolic Blood Pressure (DBP) | Change in office-measured (average of last 2 of 5 unattended measurements using an automated oscillometric sphygmomanometer device after approximately 5 minutes of rest in the seated position) DBP from baseline to the end of study at week 8. | The full analysis set included all randomized subjects who received at least 1 dose of randomized study treatment (lorundrostat or placebo). Subjects were analyzed according to the randomized study treatment group. Per the study SAP, modelled analysis comparisons for Part 2 were performed for 100 mg QD Part 2 vs 100mg QD Part 1, and not to Placebo - Part 2. Accordingly, while subjects were analyzed, modelled LSmeans for Placebo - Part 2 were not reported. | Posted | Least Squares Mean | Standard Error | mmHg | 8 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Blood Pressure ≤ 130/80 mmHg at Week 8 | Each participant was assessed as a success if the Week 8 value for SBP was ≤130 mmHg and DBP ≤80 mmHg; subjects not meeting both these thresholds were assessed as a failure. Subjects missing an assessment at Week 8 or who received rescue medications were also considered failures. | The full analysis set included all randomized subjects who received at least 1 dose of randomized study treatment (lorundrostat or placebo). Subjects were analyzed according to the randomized study treatment group. | Posted | Count of Participants | Participants | 8 Weeks |
|
12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting.
Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment.
On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2.
Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo - Part 1 | Participants received matching placebo, taken orally, for 8 weeks in Part 1 of the study | 0 | 30 | 0 | 30 | 7 | 30 |
| EG001 | Lorundrostat 12.5 mg BID - Part 1 | Participants received 12.5 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study | 0 | 22 | 0 | 22 | 13 | 22 |
| EG002 | Lorundrostat 25 mg BID - Part 1 | Participants received 25 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study | 0 | 30 | 0 | 30 | 18 | 30 |
| EG003 | Lorundrostat 12.5 mg QD - Part 1 | Participants received 12.5 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study | 0 | 23 | 2 | 23 | 16 | 23 |
| EG004 | Lorundrostat 50 mg QD - Part 1 | Participants received 50 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study | 0 | 28 | 0 | 28 | 10 | 28 |
| EG005 | Lorundrostat 100 mg QD - Part 1 | Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study | 0 | 30 | 0 | 30 | 16 | 30 |
| EG006 | Placebo - Part 2 | Participants received matching placebo, taken orally, for 8 weeks in Part 2 of the study | 0 | 6 | 0 | 6 | 1 | 6 |
| EG007 | Lorundrostat 100 mg QD - Part 2 | Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 2 of the study | 0 | 31 | 1 | 31 | 19 | 31 |
| EG008 | Run-in | Participants received placebo, taken orally, for up to 2 weeks in the Run-in phase of the study | 0 | 305 | 0 | 305 | 8 | 305 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Cortisol decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Peripheral Swelling | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Haematocrit increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Monocyte count increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Platelet Count Increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| White blood cell count deceased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood corticotrophin decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Lymphocyte count increased | Investigations | MedDRA (24.0) | Systematic Assessment |
|
Following the completion of the planned interim analysis in January 2022, the two lowest doses in Part 1 (i.e., 12.5 mg QD and 12.5 mg BID) were dropped from the study and no further subjects were enrolled in these treatment arms. Accordingly, overall subject numbers in these arms is less than originally planned.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Rodman, MD Chief Medical Officer | Mineralys Therapeutics | 1-888-378-6240 | drodman@mineralystx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 4, 2022 | Oct 10, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006977 | Hypertension, Renal |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| 65-79 |
|
| >=80 |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants received 25 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study
| OG003 | Lorundrostat 12.5 mg QD - Part 1 | Participants received 12.5 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study |
| OG004 | Lorundrostat 50 mg QD - Part 1 | Participants received 50 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study |
| OG005 | Lorundrostat 100 mg QD - Part 1 | Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study |
| OG006 | Placebo - Part 2 | Participants received matching placebo, taken orally, for 8 weeks in Part 2 of the study |
| OG007 | Lorundrostat 100 mg QD - Part 2 | Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 2 of the study |
|
|
| OG003 | Lorundrostat 12.5 mg QD - Part 1 | Participants received 12.5 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study |
| OG004 | Lorundrostat 50 mg QD - Part 1 | Participants received 50 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study |
| OG005 | Lorundrostat 100 mg QD - Part 1 | Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study |
| OG006 | Placebo - Part 2 | Participants received matching placebo, taken orally, for 8 weeks in Part 2 of the study |
| OG007 | Lorundrostat 100 mg QD - Part 2 | Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 2 of the study |
|
|
| Lorundrostat 12.5 mg QD - Part 1 |
Participants received 12.5 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study |
| OG004 | Lorundrostat 50 mg QD - Part 1 | Participants received 50 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study |
| OG005 | Lorundrostat 100 mg QD - Part 1 | Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study |
| OG006 | Placebo - Part 2 | Participants received matching placebo, taken orally, for 8 weeks in Part 2 of the study |
| OG007 | Lorundrostat 100 mg QD - Part 2 | Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 2 of the study |
|
|