Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
- Registration Number
- NCT05968430
- Lead Sponsor
- Mineralys Therapeutics Inc.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1400
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Written informed consent signed by the participant, obtained before any study-related assessment is performed
-
At least 18 years of age at the time of signing the informed consent form (ICF)
-
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
-
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
-
Willing and able to comply with the study instructions and attend all scheduled study visits
[Randomized treatment withdrawal substudy only]
-
Written informed consent to participate in the RTW substudy signed by the participant, obtained before any RTW study-related assessment is performed
-
Women who are pregnant, plan to become pregnant, or are breast-feeding
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Use, or anticipated use during the course of the study, of a prohibited medication as listed in Section 6.7.1 of the protocol
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In the opinion of the Investigator, any condition that will preclude participation in the study
[Randomized treatment withdrawal substudy only]
-
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open-Label Arm lorundrostat lorundrostat once daily for 52 weeks depending on when the subject enrolled RTW Substudy lorundrostat 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 RTW Substudy Placebo 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 Optional Continuation Period lorundrostat lorundrostat once daily from week 52 or until marketing authorization or early termination of the trial by the sponsor
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (173)
Accel Research Sites (ARS) - Birmingham Clinical Research Unit
🇺🇸Birmingham, Alabama, United States
G & L Research LLC
🇺🇸Foley, Alabama, United States
Chandler Clinical Trials
🇺🇸Chandler, Arizona, United States
Arizona Kidney
🇺🇸Glendale, Arizona, United States
AKDHC Medical Research Services, AZ
🇺🇸Phoenix, Arizona, United States
Noble Clinical Research
🇺🇸Tucson, Arizona, United States
Del Sol Research Management, LLC
🇺🇸Tucson, Arizona, United States
Entertainment Medical Group, Inc
🇺🇸Beverly Hills, California, United States
CA Institute of Renal Research, CA
🇺🇸Chula Vista, California, United States
Amicis Research Center - Vacaville
🇺🇸Fairfield, California, United States
Scroll for more (163 remaining)Accel Research Sites (ARS) - Birmingham Clinical Research Unit🇺🇸Birmingham, Alabama, United States