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Trial on the Safety and Efficacy of MLS-101 in Patients With Uncontrolled Hypertension (Target-HTN)

Primary Purpose

Hypertension, Renal

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MLS-101 (Part I)
Placebo (Part I)
Placebo (Part II)
MLS-101 (Part II)
Sponsored by
Mineralys Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension, Renal focused on measuring Blood pressure, Uncontrolled hypertension, Phase II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site 103
  • Site 129
  • Site 135
  • Site 131
  • Site 105
  • Site 108
  • Site 134
  • Site 146
  • Site 137
  • Site 139
  • Site 143
  • Site 122
  • Site 102
  • Site 118
  • Site 109
  • Site 125
  • Site 136
  • Site 138
  • Site 154
  • Site 148
  • Site 114
  • Site 116
  • Site 121
  • Site 123
  • Site 141
  • Site 133
  • Site 113
  • Site 130
  • Site 140
  • Site 104
  • Site 150
  • Site 153
  • Site 115
  • Site 107
  • Site 120
  • Site 152
  • Site 151
  • Site 145
  • Site 132
  • Site 124
  • Site 147
  • Site 126
  • Site 128
  • Site 112

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Placebo (Part I)

Dose 1 (Part I)

Dose 2 (Part I)

Dose 3 (Part I)

Placebo (Part II)

Dose (Part II)

Arm Description

Placebo tablet(s) by mouth once or twice daily.

MLS-101 tablet(s) by mouth once or twice daily.

MLS-101 tablet(s) by mouth once or twice daily.

MLS-101 tablet(s) by mouth once or twice daily.

Placebo tablet(s) by mouth once daily.

MLS-101 tablet(s) by mouth once daily.

Outcomes

Primary Outcome Measures

Study-Wide Change in Systolic Blood Pressure
Overall changes in SBP

Secondary Outcome Measures

24-Hour Ambulatory Systolic and Diastolic Blood Pressure
Overall changes in ambulatory blood pressure outcomes
Weekly Changes in Systolic and Diastolic Blood Pressure
Week-to-week changes in SBP and DBP
Study-Wide Change in Diastolic Blood Pressure
Overall changes in DBP
Proportion of Subjects with ≤ 130/80 mm Hg by End of Study
Cohort-wide changes in blood pressure outcomes

Full Information

First Posted
July 20, 2021
Last Updated
February 16, 2023
Sponsor
Mineralys Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05001945
Brief Title
Trial on the Safety and Efficacy of MLS-101 in Patients With Uncontrolled Hypertension
Acronym
Target-HTN
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
September 7, 2022 (Actual)
Study Completion Date
October 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mineralys Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Renal
Keywords
Blood pressure, Uncontrolled hypertension, Phase II

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo (Part I)
Arm Type
Placebo Comparator
Arm Description
Placebo tablet(s) by mouth once or twice daily.
Arm Title
Dose 1 (Part I)
Arm Type
Experimental
Arm Description
MLS-101 tablet(s) by mouth once or twice daily.
Arm Title
Dose 2 (Part I)
Arm Type
Experimental
Arm Description
MLS-101 tablet(s) by mouth once or twice daily.
Arm Title
Dose 3 (Part I)
Arm Type
Experimental
Arm Description
MLS-101 tablet(s) by mouth once or twice daily.
Arm Title
Placebo (Part II)
Arm Type
Placebo Comparator
Arm Description
Placebo tablet(s) by mouth once daily.
Arm Title
Dose (Part II)
Arm Type
Experimental
Arm Description
MLS-101 tablet(s) by mouth once daily.
Intervention Type
Drug
Intervention Name(s)
MLS-101 (Part I)
Intervention Description
MLS-101 tablet(s) by mouth once or twice daily.
Intervention Type
Other
Intervention Name(s)
Placebo (Part I)
Intervention Description
Placebo tablet(s) by mouth once or twice daily.
Intervention Type
Other
Intervention Name(s)
Placebo (Part II)
Intervention Description
Placebo tablet(s) by mouth once daily.
Intervention Type
Drug
Intervention Name(s)
MLS-101 (Part II)
Intervention Description
MLS-101 tablet(s) by mouth once daily.
Primary Outcome Measure Information:
Title
Study-Wide Change in Systolic Blood Pressure
Description
Overall changes in SBP
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
24-Hour Ambulatory Systolic and Diastolic Blood Pressure
Description
Overall changes in ambulatory blood pressure outcomes
Time Frame
8 Weeks
Title
Weekly Changes in Systolic and Diastolic Blood Pressure
Description
Week-to-week changes in SBP and DBP
Time Frame
8 Weeks
Title
Study-Wide Change in Diastolic Blood Pressure
Description
Overall changes in DBP
Time Frame
8 Weeks
Title
Proportion of Subjects with ≤ 130/80 mm Hg by End of Study
Description
Cohort-wide changes in blood pressure outcomes
Time Frame
8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and nonpregnant, nonlactating female subjects ≥ 18 years of age. Written informed consent Health Insurance Portability and Accountability Act authorization, and local patient privacy required documentation for this study have been obtained Automated office blood pressure (AOBP) with SBP ≥ 130 mm Hg Background antihypertensive treatment of ≥ 2 drugs 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: 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
Facility Information:
Facility Name
Site 103
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
Site 129
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Site 135
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Site 131
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Site 105
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Site 108
City
Greenacres City
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Facility Name
Site 134
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Site 146
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Site 137
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Site 139
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Site 143
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Site 122
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Site 102
City
Tampa
State/Province
Florida
ZIP/Postal Code
91303
Country
United States
Facility Name
Site 118
City
Albany
State/Province
Georgia
ZIP/Postal Code
31707
Country
United States
Facility Name
Site 109
City
Fayetteville
State/Province
Georgia
ZIP/Postal Code
30214
Country
United States
Facility Name
Site 125
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30044
Country
United States
Facility Name
Site 136
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Site 138
City
Bossier City
State/Province
Louisiana
ZIP/Postal Code
71111
Country
United States
Facility Name
Site 154
City
Hammond
State/Province
Louisiana
ZIP/Postal Code
70403
Country
United States
Facility Name
Site 148
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Site 114
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
Site 116
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Site 121
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Site 123
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Facility Name
Site 141
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Site 133
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
Country
United States
Facility Name
Site 113
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Site 130
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Site 140
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Site 104
City
Morgantown
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
Site 150
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Site 153
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Site 115
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Site 107
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Site 120
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Site 152
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Site 151
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Site 145
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Facility Name
Site 132
City
Dallas
State/Province
Texas
ZIP/Postal Code
75224
Country
United States
Facility Name
Site 124
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Facility Name
Site 147
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
Site 126
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
Site 128
City
Richland Hills
State/Province
Texas
ZIP/Postal Code
76180
Country
United States
Facility Name
Site 112
City
Forest
State/Province
Virginia
ZIP/Postal Code
24551
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Trial on the Safety and Efficacy of MLS-101 in Patients With Uncontrolled Hypertension

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