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

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mineralys Therapeutics Inc.

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. PRA ≤ 0.6 ng/mL

6. Serum aldosterone ≥ 6 ng/dL

7. 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

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

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