Open-Label Extension Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Uncontrolled Hypertension
Purpose
This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled hypertension.
Condition
- Hypertension
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Participation in a lorundrostat study with the option of transitioning to the OLE study 3. 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 4. Willing and able to comply with the study instructions and attend all scheduled study visits 5. [Randomized treatment withdrawal only] A minimum of 75% and a maximum of 125% compliance with lorundrostat from Week 32 to Week 48 of the OLE 6. [Randomized treatment withdrawal only] Taking an oral dose of lorundrostat of at least 25 mg once daily
Exclusion Criteria
- Women who are pregnant, plan to become pregnant, or are breast-feeding 2. In the opinion of the principal investigator, any other condition that will preclude participation in the study
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Double
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Open-Label Arm |
lorundrostat once daily for 48 weeks |
|
|
Experimental Maintenance Arm |
lorundrostat once daily for 4 weeks in the double-blind randomized treatment withdrawal sub-study |
|
|
Experimental Taper Arm |
lorundrostat and/or placebo once daily for 4 weeks in the double-blind randomized treatment withdrawal sub-study |
|
|
Placebo Comparator Placebo |
Placebo once daily for 4 weeks in the double-blind randomized treatment withdrawal sub-study |
|
Recruiting Locations
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- Mineralys Therapeutics Inc.
Detailed Description
This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled hypertension. The study consists of an open-label dose treatment period of 48 weeks, followed by a 4-week double-blind randomized treatment withdrawal sub-study. The study will conclude with a 2-week wash-out period. To be eligible, subjects must complete the double-blind treatment phase of a respective parent study (including, but not limited to MLS-101-202 and MLS-101-301) and agree to transition immediately to this open-label extension (OLE) study (ie, will not participate in the end of study observation period of the parent study). The study will be conducted at approximately 200 centers.