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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.

Tracking Information
First Submitted Date  ICMJE July 20, 2021
First Posted Date  ICMJE August 12, 2021
Last Update Posted Date May 6, 2022
Actual Study Start Date  ICMJE July 1, 2021
Estimated Primary Completion Date July 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2021)		 Study-Wide Change in Systolic Blood Pressure [ Time Frame: 8 Weeks ]
Overall changes in SBP
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2021)
  • 24-Hour Ambulatory Systolic and Diastolic Blood Pressure [ Time Frame: 8 Weeks ]
    Overall changes in ambulatory blood pressure outcomes
  • Weekly Changes in Systolic and Diastolic Blood Pressure [ Time Frame: 8 Weeks ]
    Week-to-week changes in SBP and DBP
  • Study-Wide Change in Diastolic Blood Pressure [ Time Frame: 8 Weeks ]
    Overall changes in DBP
  • Proportion of Subjects with ≤ 130/80 mm Hg by End of Study [ Time Frame: 8 Weeks ]
    Cohort-wide changes in blood pressure outcomes
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial on the Safety and Efficacy of MLS-101 in Patients With Uncontrolled Hypertension
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypertension, Renal
Intervention  ICMJE
  • Drug: MLS-101 (Part I)
    MLS-101 tablet(s) by mouth once or twice daily.
  • Other: Placebo (Part I)
    Placebo tablet(s) by mouth once or twice daily.
  • Other: Placebo (Part II)
    Placebo tablet(s) by mouth once daily.
  • Drug: MLS-101 (Part II)
    MLS-101 tablet(s) by mouth once daily.
Study Arms  ICMJE
  • Placebo Comparator: Placebo (Part I)
    Placebo tablet(s) by mouth once or twice daily.
    Intervention: Other: Placebo (Part I)
  • Experimental: Dose 1 (Part I)
    MLS-101 tablet(s) by mouth once or twice daily.
    Intervention: Drug: MLS-101 (Part I)
  • Experimental: Dose 2 (Part I)
    MLS-101 tablet(s) by mouth once or twice daily.
    Intervention: Drug: MLS-101 (Part I)
  • Experimental: Dose 3 (Part I)
    MLS-101 tablet(s) by mouth once or twice daily.
    Intervention: Drug: MLS-101 (Part I)
  • Placebo Comparator: Placebo (Part II)
    Placebo tablet(s) by mouth once daily.
    Intervention: Other: Placebo (Part II)
  • Experimental: Dose (Part II)
    MLS-101 tablet(s) by mouth once daily.
    Intervention: Drug: MLS-101 (Part II)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 2, 2022)		 196
Original Estimated Enrollment  ICMJE
 (submitted: August 11, 2021)		 180
Estimated Study Completion Date  ICMJE October 1, 2022
Estimated Primary Completion Date July 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sharon Reagan 1-732-693-8608 sreaagan@mineralystx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05001945
Other Study ID Numbers  ICMJE MLS-101-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Mineralys Therapeutics Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mineralys Therapeutics Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mineralys Therapeutics Inc.
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP