Trial on the Safety and Efficacy of MLS-101 in Patients With Uncontrolled Hypertension
NCT ID: NCT05001945
Last Updated: 2024-01-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2021-07-01
2022-10-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo (Part I)
Placebo tablet(s) by mouth once or twice daily.
Placebo (Part I)
Placebo tablet(s) by mouth once or twice daily.
Dose 1 (Part I)
MLS-101 tablet(s) by mouth once or twice daily.
MLS-101 (Part I)
MLS-101 tablet(s) by mouth once or twice daily.
Dose 2 (Part I)
MLS-101 tablet(s) by mouth once or twice daily.
MLS-101 (Part I)
MLS-101 tablet(s) by mouth once or twice daily.
Dose 3 (Part I)
MLS-101 tablet(s) by mouth once or twice daily.
MLS-101 (Part I)
MLS-101 tablet(s) by mouth once or twice daily.
Placebo (Part II)
Placebo tablet(s) by mouth once daily.
Placebo (Part II)
Placebo tablet(s) by mouth once daily.
Dose (Part II)
MLS-101 tablet(s) by mouth once daily.
MLS-101 (Part II)
MLS-101 tablet(s) by mouth once daily.
Interventions
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MLS-101 (Part I)
MLS-101 tablet(s) by mouth once or twice daily.
Placebo (Part I)
Placebo tablet(s) by mouth once or twice daily.
Placebo (Part II)
Placebo tablet(s) by mouth once daily.
MLS-101 (Part II)
MLS-101 tablet(s) by mouth once daily.
Eligibility Criteria
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Inclusion Criteria
2. Written informed consent Health Insurance Portability and Accountability Act authorization, and local patient privacy required documentation for this study have been obtained
3. Automated office blood pressure (AOBP) with SBP ≥ 130 mm Hg
4. Background antihypertensive treatment of ≥ 2 drugs
5. Serum cortisol ≥ 18 mcg/dL
Exclusion Criteria
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:
1. Topical corticoids
2. Sympathomimetic decongestants
3. Theophylline
4. Phosphodiesterase type 5 inhibitors
5. NSAIDs
6. Intramuscular steroids
7. Estrogen
8. Cytochromes
9. 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
18 Years
ALL
No
Sponsors
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Mineralys Therapeutics Inc.
INDUSTRY
Responsible Party
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Locations
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Site 103
Lincoln, California, United States
Site 129
Torrance, California, United States
Site 135
Tustin, California, United States
Site 131
Clearwater, Florida, United States
Site 105
Coral Gables, Florida, United States
Site 108
Greenacres City, Florida, United States
Site 134
Jupiter, Florida, United States
Site 146
Miami, Florida, United States
Site 137
Miami, Florida, United States
Site 139
Miami, Florida, United States
Site 143
Miami, Florida, United States
Site 122
Pembroke Pines, Florida, United States
Site 102
Tampa, Florida, United States
Site 118
Albany, Georgia, United States
Site 109
Fayetteville, Georgia, United States
Site 125
Lawrenceville, Georgia, United States
Site 136
Arlington Heights, Illinois, United States
Site 138
Bossier City, Louisiana, United States
Site 154
Hammond, Louisiana, United States
Site 148
Shreveport, Louisiana, United States
Site 114
Slidell, Louisiana, United States
Site 116
Jefferson City, Missouri, United States
Site 121
St Louis, Missouri, United States
Site 123
Las Vegas, Nevada, United States
Site 141
Jamaica, New York, United States
Site 133
Asheboro, North Carolina, United States
Site 113
Charlotte, North Carolina, United States
Site 130
Fayetteville, North Carolina, United States
Site 140
Greensboro, North Carolina, United States
Site 104
Morgantown, North Carolina, United States
Site 150
Raleigh, North Carolina, United States
Site 153
Cleveland, Ohio, United States
Site 115
Rapid City, South Dakota, United States
Site 107
Chattanooga, Tennessee, United States
Site 120
Kingsport, Tennessee, United States
Site 152
Nashville, Tennessee, United States
Site 151
Arlington, Texas, United States
Site 145
Cypress, Texas, United States
Site 132
Dallas, Texas, United States
Site 124
McKinney, Texas, United States
Site 147
Mesquite, Texas, United States
Site 126
Pearland, Texas, United States
Site 128
Richland Hills, Texas, United States
Site 112
Forest, Virginia, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MLS-101-201
Identifier Type: -
Identifier Source: org_study_id
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