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

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ClinicalTrials.gov Identifier: NCT05001945
Recruitment Status : Recruiting
First Posted : August 12, 2021
Last Update Posted : May 6, 2022
Sponsor:
Information provided by (Responsible Party):
Mineralys Therapeutics Inc.

Study Description
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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
Hypertension, Renal Drug: MLS-101 (Part I) Other: Placebo (Part I) Other: Placebo (Part II) Drug: MLS-101 (Part II) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 1, 2021
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Study-Wide Change in Systolic Blood Pressure [ Time Frame: 8 Weeks ]
    Overall changes in SBP


Secondary Outcome Measures :
  1. 24-Hour Ambulatory Systolic and Diastolic Blood Pressure [ Time Frame: 8 Weeks ]
    Overall changes in ambulatory blood pressure outcomes

  2. Weekly Changes in Systolic and Diastolic Blood Pressure [ Time Frame: 8 Weeks ]
    Week-to-week changes in SBP and DBP

  3. Study-Wide Change in Diastolic Blood Pressure [ Time Frame: 8 Weeks ]
    Overall changes in DBP

  4. Proportion of Subjects with ≤ 130/80 mm Hg by End of Study [ Time Frame: 8 Weeks ]
    Cohort-wide changes in blood pressure outcomes


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05001945


Contacts
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Contact: Sharon Reagan 1-732-693-8608 sreaagan@mineralystx.com

Locations
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Sponsors and Collaborators
Mineralys Therapeutics Inc.
More Information
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Responsible Party: Mineralys Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT05001945    
Other Study ID Numbers: MLS-101-201
First Posted: August 12, 2021    Key Record Dates
Last Update Posted: May 6, 2022
Last Verified: May 2022

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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:
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Hypertension, Renal
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Kidney Diseases
Urologic Diseases