Clinical trial NCT05001945: Trial on the Safety and Efficacy of MLS-101 in Patients With Uncontrolled Hypertension
Official title: A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multicenter Phase 2 Study to Evaluate the Safety, Efficacy, and Tolerability of MLS-101 in Subjects With Uncontrolled Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension, Renal
Keywords: Blood pressure
Uncontrolled hypertension
Phase II
Lead sponsor: Mineralys Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

1. Male and nonpregnant, nonlactating female subjects ≥ 18 years of age.
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:

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:

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

Primary outcomes:
measure: Change From Baseline in Office-measured Systolic Blood Pressure (SBP) at Study Week 8 Compared to Placebo
timeFrame: 8 Weeks
Secondary outcomes:
measure: 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)
timeFrame: 8 Weeks
measure: Week 8 Change From Baseline in Office-measured Diastolic Blood Pressure (DBP)
timeFrame: 8 weeks
measure: Number of Participants With Blood Pressure ≤ 130/80 mmHg at Week 8
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Site 103
state: California
city: Torrance
country: United States
facility: Site 129
state: California
city: Tustin
country: United States
facility: Site 135
state: California
city: Clearwater
country: United States
facility: Site 131
state: Florida
city: Coral Gables
country: United States
facility: Site 105
state: Florida
city: Greenacres City
country: United States
facility: Site 108
state: Florida
city: Jupiter
country: United States
facility: Site 134
state: Florida
city: Miami
country: United States
facility: Site 146
state: Florida
city: Miami
country: United States
facility: Site 137
state: Florida
city: Miami
country: United States
facility: Site 139
state: Florida
city: Miami
country: United States
facility: Site 143
state: Florida
city: Pembroke Pines
country: United States
facility: Site 122
state: Florida
city: Tampa
country: United States
facility: Site 102
state: Florida
city: Albany
country: United States
facility: Site 118
state: Georgia
city: Fayetteville
country: United States
facility: Site 109
state: Georgia
city: Lawrenceville
country: United States
facility: Site 125
state: Georgia
city: Arlington Heights
country: United States
facility: Site 136
state: Illinois
city: Bossier City
country: United States
facility: Site 138
state: Louisiana
city: Hammond
country: United States
facility: Site 154
state: Louisiana
city: Shreveport
country: United States
facility: Site 148
state: Louisiana
city: Slidell
country: United States
facility: Site 114
state: Louisiana
city: Jefferson City
country: United States
facility: Site 116
state: Missouri
city: Saint Louis
country: United States
facility: Site 121
state: Missouri
city: Las Vegas
country: United States
facility: Site 123
state: Nevada
city: Jamaica
country: United States
facility: Site 141
state: New York
city: Asheboro
country: United States
facility: Site 133
state: North Carolina
city: Charlotte
country: United States
facility: Site 113
state: North Carolina
city: Fayetteville
country: United States
facility: Site 130
state: North Carolina
city: Greensboro
country: United States
facility: Site 140
state: North Carolina
city: Morgantown
country: United States
facility: Site 104
state: North Carolina
city: Raleigh
country: United States
facility: Site 150
state: North Carolina
city: Cleveland
country: United States
facility: Site 153
state: Ohio
city: Rapid City
country: United States
facility: Site 115
state: South Dakota
city: Chattanooga
country: United States
facility: Site 107
state: Tennessee
city: Kingsport
country: United States
facility: Site 120
state: Tennessee
city: Nashville
country: United States
facility: Site 152
state: Tennessee
city: Arlington
country: United States
facility: Site 151
state: Texas
city: Cypress
country: United States
facility: Site 145
state: Texas
city: Dallas
country: United States
facility: Site 132
state: Texas
city: McKinney
country: United States
facility: Site 124
state: Texas
city: Mesquite
country: United States
facility: Site 147
state: Texas
city: Pearland
country: United States
facility: Site 126
state: Texas
city: Richland Hills
country: United States
facility: Site 128
state: Texas
city: Forest
country: United States
facility: Site 112
state: Virginia
Study officials:
References: