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

Mineralys Therapeutics

Status and phase: Completed; Phase 2

Conditions: Hypertension, Renal

Treatments: Drug: MLS-101 (Part I); Other: Placebo (Part II); Other: Placebo (Part I); Drug: MLS-101 (Part II)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05001945

MLS-101-201

Details and patient eligibility

About

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

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

2. Subjects with hypokalemia

3. Subjects with hyperkalemia

4. Subjects with serum cortisol < 3 mcg/dL

5. Subjects with serum sodium < 135 mEq/L

6. Subjects with estimated glomerular filtration rate < 60 mL/min/1.73m2

7. Subjects with type 1 or uncontrolled (hemoglobin A1c ≥ 9%) type 2 diabetes mellitus

8. Subjects with body mass index > 40 kg/m2

9. Subjects with unstable angina

10. 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

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

12. Subjects who, in the opinion of the investigator, have suspected nonadherence to antihypertensive treatment

13. Subjects who, in the opinion of the investigator, have any major medical illness or symptoms

14. Subjects who, in the opinion of the investigator, have any acute or chronic medical or psychiatric condition

15. Subjects undergoing treatment with any of the following medications:

16. Topical corticoids

17. Sympathomimetic decongestants

18. Theophylline

19. Phosphodiesterase type 5 inhibitors

20. NSAIDs

21. Intramuscular steroids

22. Estrogen

23. Cytochromes

24. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 6 patient groups, including a placebo group

Placebo (Part I)

Placebo Comparator group

Description:

Placebo tablet(s) by mouth once or twice daily.

Treatment:

Other: Placebo (Part I)

Dose 1 (Part I)

Experimental group

Description:

MLS-101 tablet(s) by mouth once or twice daily.

Treatment:

Drug: MLS-101 (Part I)

Dose 2 (Part I)

Experimental group

Description:

MLS-101 tablet(s) by mouth once or twice daily.

Treatment:

Drug: MLS-101 (Part I)

Dose 3 (Part I)

Experimental group

Description:

MLS-101 tablet(s) by mouth once or twice daily.

Treatment:

Drug: MLS-101 (Part I)

Placebo (Part II)

Placebo Comparator group

Description:

Placebo tablet(s) by mouth once daily.

Treatment:

Other: Placebo (Part II)

Dose (Part II)

Experimental group

Description:

MLS-101 tablet(s) by mouth once daily.

Treatment:

Drug: MLS-101 (Part II)