Phase 2
N=200
Trial on the Safety and Efficacy of MLS-101 in Patients With Uncontrolled Hypertension
Hypertension, Renal
Bottom Line
View on ClinicalTrials.gov: NCT05001945 ↗Enrolled (actual)
200
Serious AEs
0.6%
Results posted
Jan 2024
Primary outcome: Primary: Change From Baseline in Office-measured Systolic Blood Pressure (SBP) at Study Week 8 Compared to Placebo — -4.10; -11.3; -11.07; -5.63 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MLS-101 (Part I) (Drug); Placebo (Part I) (Other); Placebo (Part II) (Other); MLS-101 (Part II) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mineralys Therapeutics Inc.
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Office-measured Systolic Blood Pressure (SBP) at Study Week 8 Compared to Placebo |
-4.10; -11.3; -11.07; -5.63; -13.69; -11.92 | — |
| SECONDARY 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) |
-1.01; -5.78; -9.05; -2.51; -4.86; -6.34 | — |
| SECONDARY Week 8 Change From Baseline in Office-measured Diastolic Blood Pressure (DBP) |
-1.63; -5.47; -4.12; -3.76; -7.09; -5.75 | — |
| SECONDARY Number of Participants With Blood Pressure ≤ 130/80 mmHg at Week 8 |
7; 7; 13; 6; 12; 9 | — |
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
Eligibility Criteria
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 40 kg/m2
- Subjects with unstable angina
- 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 a decrease in SBP ≥ 20 mm Hg or DBP ≥ 10 mm Hg from sitting to standing position at screening
- 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
Data sourced from ClinicalTrials.gov (NCT05001945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.