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

Sponsor
Mineralys Therapeutics Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05001945
Collaborator
(none)
196
Enrollment
44
Locations
6
Arms
15
Anticipated Duration (Months)
4.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: MLS-101 (Part I)
  • Other: Placebo (Part I)
  • Other: Placebo (Part II)
  • Drug: MLS-101 (Part II)
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
196 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo (Part I)

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

Other: Placebo (Part I)
Placebo tablet(s) by mouth once or twice daily.
Experimental: Dose 1 (Part I)

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

Drug: MLS-101 (Part I)
MLS-101 tablet(s) by mouth once or twice daily.
Experimental: Dose 2 (Part I)

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

Drug: MLS-101 (Part I)
MLS-101 tablet(s) by mouth once or twice daily.
Experimental: Dose 3 (Part I)

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

Drug: MLS-101 (Part I)
MLS-101 tablet(s) by mouth once or twice daily.
Placebo Comparator: Placebo (Part II)

Placebo tablet(s) by mouth once daily.

Other: Placebo (Part II)
Placebo tablet(s) by mouth once daily.
Experimental: Dose (Part II)

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

Drug: MLS-101 (Part II)
MLS-101 tablet(s) by mouth once daily.

Outcome Measures

Primary Outcome Measures

  1. Study-Wide Change in Systolic Blood Pressure [8 Weeks]

    Overall changes in SBP

Secondary Outcome Measures

  1. 24-Hour Ambulatory Systolic and Diastolic Blood Pressure [8 Weeks]

    Overall changes in ambulatory blood pressure outcomes

  2. Weekly Changes in Systolic and Diastolic Blood Pressure [8 Weeks]

    Week-to-week changes in SBP and DBP

  3. Study-Wide Change in Diastolic Blood Pressure [8 Weeks]

    Overall changes in DBP

  4. Proportion of Subjects with ≤ 130/80 mm Hg by End of Study [8 Weeks]

    Cohort-wide changes in blood pressure outcomes

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  2. Subjects with hypokalemia

  3. Subjects with hyperkalemia

  4. Subjects with serum cortisol < 3 mcg/dL

  5. Subjects with serum sodium < 135 mEq/L

  6. Subjects with estimated glomerular filtration rate < 60 mL/min/1.73m2

  7. Subjects with type 1 or uncontrolled (hemoglobin A1c ≥ 9%) type 2 diabetes mellitus

  8. Subjects with body mass index > 40 kg/m2

  9. Subjects with unstable angina

  10. 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

  11. Subjects with a decrease in SBP ≥ 20 mm Hg or DBP ≥ 10 mm Hg from sitting to standing position at screening

  12. Subjects who, in the opinion of the investigator, have suspected nonadherence to antihypertensive treatment

  13. Subjects who, in the opinion of the investigator, have any major medical illness or symptoms

  14. Subjects who, in the opinion of the investigator, have any acute or chronic medical or psychiatric condition

  15. Subjects undergoing treatment with any of the following medications:

  16. Topical corticoids

  17. Sympathomimetic decongestants

  18. Theophylline

  19. Phosphodiesterase type 5 inhibitors

  20. NSAIDs

  21. Intramuscular steroids

  22. Estrogen

  23. Cytochromes

  24. Strong CYP3A and CYP3A4 inducers

  25. Subjects with known hypersensitivity to MLS-101 or any of the excipients

  26. Subjects who are night-shift workers

Contacts and Locations

Locations

Site City State Country Postal Code
1 Site 103 Lincoln California United States 95648
2 Site 129 Torrance California United States 90502
3 Site 135 Tustin California United States 92780
4 Site 131 Clearwater Florida United States 33765
5 Site 105 Coral Gables Florida United States 33134
6 Site 108 Greenacres City Florida United States 33467
7 Site 134 Jupiter Florida United States 33458
8 Site 146 Miami Florida United States 33126
9 Site 137 Miami Florida United States 33135
10 Site 139 Miami Florida United States 33135
11 Site 143 Miami Florida United States 33144
12 Site 122 Pembroke Pines Florida United States 33026
13 Site 102 Tampa Florida United States 91303
14 Site 118 Albany Georgia United States 31707
15 Site 109 Fayetteville Georgia United States 30214
16 Site 125 Lawrenceville Georgia United States 30044
17 Site 136 Arlington Heights Illinois United States 60005
18 Site 138 Bossier City Louisiana United States 71111
19 Site 154 Hammond Louisiana United States 70403
20 Site 148 Shreveport Louisiana United States 71105
21 Site 114 Slidell Louisiana United States 70458
22 Site 116 Jefferson City Missouri United States 65109
23 Site 121 Saint Louis Missouri United States 63141
24 Site 123 Las Vegas Nevada United States 89121
25 Site 141 Jamaica New York United States 11432
26 Site 133 Asheboro North Carolina United States 27203
27 Site 113 Charlotte North Carolina United States 28210
28 Site 130 Fayetteville North Carolina United States 28304
29 Site 140 Greensboro North Carolina United States 27408
30 Site 104 Morgantown North Carolina United States 28655
31 Site 150 Raleigh North Carolina United States 27612
32 Site 153 Cleveland Ohio United States 44195
33 Site 115 Rapid City South Dakota United States 57702
34 Site 107 Chattanooga Tennessee United States 37421
35 Site 120 Kingsport Tennessee United States 37660
36 Site 152 Nashville Tennessee United States 37232
37 Site 151 Arlington Texas United States 76012
38 Site 145 Cypress Texas United States 77429
39 Site 132 Dallas Texas United States 75224
40 Site 124 McKinney Texas United States 75071
41 Site 147 Mesquite Texas United States 75149
42 Site 126 Pearland Texas United States 77584
43 Site 128 Richland Hills Texas United States 76180
44 Site 112 Forest Virginia United States 24551

Sponsors and Collaborators

  • Mineralys Therapeutics Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mineralys Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT05001945
Other Study ID Numbers:
  • MLS-101-201
First Posted:
Aug 12, 2021
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mineralys Therapeutics Inc.
Blood pressure
Uncontrolled hypertension
Phase II
Additional relevant MeSH terms:
Hypertension, Renal
Hypertension

Study Results

No Results Posted as of May 6, 2022