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

  • STATUS
    Recruiting
  • End date
    Oct 1, 2022
  • participants needed
    196
  • sponsor
    Mineralys Therapeutics Inc.
Updated on 12 May 2022

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

Details
Condition Hypertension, Renal
Treatment Placebo, MLS-101, MLS-101 (Part I), Placebo (Part I), Placebo (Part II), MLS-101 (Part II)
Clinical Study IdentifierNCT05001945
SponsorMineralys Therapeutics Inc.
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

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

Concomitant use of epithelial sodium channel inhibitors or mineralocorticoid receptor antagonists
Subjects with hypokalemia
Subjects with hyperkalemia
Subjects with serum cortisol < 3 mcg/dL
Subjects with serum sodium < 135 mEq/L
Subjects with estimated glomerular filtration rate < 60 mL/min/1.73m2
Subjects with type 1 or uncontrolled (hemoglobin A1c ≥ 9%) type 2 diabetes mellitus
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
Subjects with body mass index > 40 kg/m2
Subjects with a decrease in SBP ≥ 20 mm Hg or DBP ≥ 10 mm Hg from sitting to standing position at screening
Subjects with unstable angina
Subjects who, in the opinion of the investigator, have suspected nonadherence to antihypertensive treatment
Subjects who, in the opinion of the investigator, have any major medical illness or symptoms
Subjects who, in the opinion of the investigator, have any acute or chronic medical or psychiatric condition
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
Subjects with known hypersensitivity to MLS-101 or any of the excipients
Subjects who are night-shift workers
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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