Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
Purpose
This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension
Condition
- Hypertension
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- 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 (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
- 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
- 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
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Open-Label Arm |
lorundrostat once daily for 52 weeks depending on when the subject enrolled |
|
|
Experimental RTW Substudy |
lorundrostat or placebo once daily for 4 weeks starting at week 12, in the double-blind randomized treatment withdrawal substudy Optional for subjects from the MLS-101-301 parent study only |
|
|
Experimental Optional Continuation Period |
lorundrostat once daily from week 52 or until marketing authorization or early termination of the trial by the sponsor |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Mineralys Therapeutics Inc.
Study Contact
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.