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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05001945
Recruitment Status : Completed
First Posted : August 12, 2021
Results First Posted : January 5, 2024
Last Update Posted : January 5, 2024
Sponsor:
Information provided by (Responsible Party):
Mineralys Therapeutics Inc.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 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
Actual Primary Completion Date : September 7, 2022
Actual Study Completion Date : October 7, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change From Baseline in Office-measured Systolic Blood Pressure (SBP) at Study Week 8 Compared to Placebo [ Time Frame: 8 Weeks ]
    The primary outcome was defined as the change in office-measured (mean of last 2 of 5 unattended measurements using an automated oscillometric sphygmomanometer device after approximately 5 minutes of rest in the seated position) SBP from baseline to the end of Study Week 8. The primary efficacy analysis was performed using a mixed model repeated measures (MMRM) approach with defined fixed effects per the statistical analysis plan. A least-square estimate of the mean difference between each dose group and the placebo group is provided for Week 8.


Secondary Outcome Measures :
  1. 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) [ Time Frame: 8 Weeks ]
    The ABPM SBP was measured at baseline and EoT. Change in ABPM-derived mean SBP and DBP from baseline to EoT was analyzed using an ANCOVA with a term for treatment group and a baseline mean 24-hour value as a covariate.

  2. Week 8 Change From Baseline in Office-measured Diastolic Blood Pressure (DBP) [ Time Frame: 8 weeks ]
    Change in office-measured (average of last 2 of 5 unattended measurements using an automated oscillometric sphygmomanometer device after approximately 5 minutes of rest in the seated position) DBP from baseline to the end of study at week 8.

  3. Number of Participants With Blood Pressure ≤ 130/80 mmHg at Week 8 [ Time Frame: 8 Weeks ]
    Each participant was assessed as a success if the Week 8 value for SBP was ≤130 mmHg and DBP ≤80 mmHg; subjects not meeting both these thresholds were assessed as a failure. Subjects missing an assessment at Week 8 or who received rescue medications were also considered failures.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


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


Locations
Show Show 44 study locations
Sponsors and Collaborators
Mineralys Therapeutics Inc.
  Study Documents (Full-Text)

Documents provided by Mineralys Therapeutics Inc.:
Study Protocol  [PDF] July 7, 2022
Statistical Analysis Plan  [PDF] October 4, 2022

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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
Results First Posted: January 5, 2024
Last Update Posted: January 5, 2024
Last Verified: January 2024

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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
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases