Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
- Summary
- This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension
- Short title
- Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
- Official title
- An Open-Label Extension Study to Assess the Long-Term Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2027-05-01
- First posted
- 2023-08-01
- Registry last updated
- 2026-07-24
- Primary completion date
- 2025-12-30
- Start date
- 2023-07-14
- Actual participants
- 1,076
- Participants
- 1,076
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Mineralys Therapeutics Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05968430
- ClinicalTrials.gov ID
- NCT05968430
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Single group
- Purpose
- Treatment
- Masking
- No masking
- 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
Change from MLS-101-301 baseline automated office blood pressure
Timeframe: 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
Timeframe: Week 16
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
-
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
-
Use, or anticipated use during the course of the study, of a prohibited medication as listed in Section 6.7.1 of the protocol
-
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
- Accel Research Sites (ARS) - Birmingham Clinical Research UnitBirmingham, United States
- G & L Research LLCFoley, United States
- Chandler Clinical TrialsChandler, United States
- Arizona KidneyGlendale, United States
- AKDHC Medical Research Services, AZPhoenix, United States
- Noble Clinical ResearchTucson, United States
- Del Sol Research Management, LLCTucson, United States
- Entertainment Medical Group, IncBeverly Hills, United States
- CA Institute of Renal Research, CAChula Vista, United States
- Amicis Research Center - VacavilleFairfield, United States
- Amicis Research Center - Granada HillsGranada Hills, United States
- Marvel Clinical Research 002, LLCHuntington Beach, United States
- University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI)La Jolla, United States
- Clinical Trials Research (CTR) - LincolnLincoln, United States
- Academic Medical Research Institute (AMRI) - Los AngelesLos Angeles, United States
- Cedars-Sinai Medical CenterLos Angeles, United States
- Amicis Research Center - Mission HillsNorthridge, United States
- Amicis Research Center-NorthridgeNorthridge, United States
- Northridge Clinical TrialsNorthridge, United States
- Pasadena Clinical TrialsPasadena, United States
- Empire Clinical ResearchPomona, United States
- Clinical Trials Research (CTR) - SacramentoSacramento, United States
- Triwest Research AssociatesSan Diego, United States
- San Jose Clinical TrialsSan Jose, United States
- Amicis Research Center - ValenciaValencia, United States
And 152 more, listed on the interactive page.
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Hypertensive disorder Primary condition