Hypertension
Conditions
Keywords
Blood pressure, Uncontrolled hypertension, Hypertension, Hypertensive
Brief summary
This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension
Detailed description
The purpose of the study is to evaluate the long-term safety, efficacy, and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension. This study consists of an open label treatment period of 52 weeks followed by a 2-week safety follow-up period. Eligible subjects for MLS-101-901 are those who were enrolled in one of the eligible parent studies, meet the eligibility criteria for this protocol, and agree, by signing an informed consent form (ICF), to transition to this open label extension (OLE) study at either the end-of-study (EoS) visit or the end-of-treatment (EoT) visit as required in the parent study protocol. A Randomized Treatment Withdrawal (RTW) substudy will be performed in a subset of subjects meeting eligibility criteria. Subjects who complete the open label treatment period will be invited to consent to an optional continuation period where they may remain on study until marketing authorization or early termination of the trial by the sponsor.
Interventions
DRUGlorundrostat
Tablet, administered orally
DRUGPlacebo
Tablet, administered orally
Sponsors
Mineralys Therapeutics Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Eligible subjects participating in the RTW will receive double-blind treatment with matching placebo. Upon completion, subjects will return to open-label treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent signed by the participant, obtained before any study-related assessment is performed 2. At least 18 years of age at the time of signing the informed consent form (ICF) 3. Completed the EoT or EoS Visit (as applicable) in a lorundrostat study with the option of transitioning to the OLE study, in accordance with the parent study protocol 4. Fertile male subjects and female subjects of childbearing potential, and their partners, must agree to use an acceptable method of contraception from study entry to 28 days after the last dose of study drug 5. Willing and able to comply with the study instructions and attend all scheduled study visits \[Randomized treatment withdrawal substudy only\] 6. Written informed consent to participate in the RTW substudy signed by the participant, obtained before any RTW study-related assessment is performed
Exclusion criteria
1. Women who are pregnant, plan to become pregnant, or are breast-feeding 2. Use, or anticipated use during the course of the study, of a prohibited medication as listed in Section 6.7.1 of the protocol 3. In the opinion of the Investigator, any condition that will preclude participation in the study \[Randomized treatment withdrawal substudy only\] 4. Non-compliance with study medication(s) (defined as taking \<75% or \>125% of the study drug provided) during the first 12 weeks of MLS-101-901
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from MLS-101-301 baseline automated office blood pressure | Week 36 | Change from MLS-101-301 baseline automated office blood pressure (AOBP) systolic blood pressure (SBP) at MLS-101-901 Week 36 in subjects who were enrolled in the lorundrostat arms of MLS-101-301 and were not assigned to the placebo arm of the MLS-101-901 RTW substudy |
| Change at MLS-101-901 Week 16 (RTW Week 4) from MLS 101-901 Week 12 (RTW substudy baseline) in AOBP SBP in subjects enrolled in RTW | Week 16 | — |
Countries
Australia, Bulgaria, Canada, France, Germany, Italy, Netherlands, Poland, Puerto Rico, Romania, Spain, United Kingdom, United States
Outcome results
None listed