Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
← catalyst calendarSponsored by Mineralys Therapeutics Inc. (industry) · MLYS — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
1,076actual
Sites
177
Countries
Australia, Bulgaria, Canada +10
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-07-14 | actual | When the study began enrolling |
| Primary completion | 2025-12-30 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | May 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2023-08-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-24 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Hypertension
Interventions
- Drug: lorundrostat
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFChange from MLS-101-301 baseline automated office blood pressure
measured Week 36
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
measured Week 16
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