> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/open-label-extension-ole-study-to-assess-safety-efficacy-and-2b291777-4813-4ae7-91bb-a3e8b1329e69 > Record changed: 2026-10-13 # Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension NCT05968430 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) Participants 1,076 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) Lead sponsor Mineralys Therapeutics Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) Start date 2023-07-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) Number of sites 177 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) ## Title and summary **Summary** This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) **Short title** Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) **Official title** An Open-Label Extension Study to Assess the Long-Term Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) ## Dates **Completion date** 2027-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) **First posted** 2023-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) **Registry last updated** 2026-07-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) **Primary completion date** 2025-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) **Start date** 2023-07-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) ## Size and sites **Actual participants** 1,076 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) **Participants** 1,076 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) **Protocol amendments** 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) **Number of sites** 177 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) **Lead sponsor** Mineralys Therapeutics Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) ## Identifiers **Registry ID** NCT05968430 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) **ClinicalTrials.gov ID** NCT05968430 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) ## Study design **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 Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) ## Outcomes ### Primary outcomes 1. 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 2. 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 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) ## Sites - 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. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05968430) ## Related records ### Drugs (1) - [Lorundrostat](https://trialight.com/data/asset/lorundrostat-c0863b53-0f6c-4044-b54f-78bf207c9c16.md) ### Lead sponsors (1) - [Mineralys Therapeutics Inc.](https://trialight.com/data/company/mineralys-therapeutics-inc-2ef4e012-fde3-4ebc-a266-37dc2b7710e1.md) ### Conditions (1) - [Hypertensive disorder](https://trialight.com/data/condition/hypertensive-disorder-6d786557-b9e8-5afc-80f3-89a1995f9da5.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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