NCT05968430Phase 3Active not recruiting

Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension

Study sponsor: Mineralys Therapeutics Inc. · MLYS

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2025-12-30Actual

Enrollment · participants1076Actual

Source updated2026-09-28Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-01-30 · 4 fields changed

Participant count type changed

− Before

~~Estimated~~

+ After

Actual

Enrollment · participant count changed

− Before

~~1400 participants (planned)~~

+ After

1076 participants (actual)

Completion date type changed

− Before

~~Estimated~~

+ After

Actual

Primary completion date changed

− Before

~~Dec 2025~~

+ After

30 Dec 2025

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Study details

Conditions studied

Hypertension

Treatments or interventions studied

lorundrostatDrug
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Change from MLS-101-301 baseline automated office blood pressure; description: 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; timeFrame: Week 36; measure: 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

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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