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MLS-101-901: An Open-Label Extension Study to Assess the Long-Term Safety, Efficacy, and Tolerability of Lorundrostat in Subjects with Hypertension

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508670-28-00
Acronym
MLS-101-901
Enrollment
370
Registered
2024-08-14
Start date
2024-08-26
Completion date
Unknown
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

Change from MLS-101-301 baseline automated office blood pressure (AOBP) 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 (Objective: To assess the long-term maintenance of the AHT effect of lorundrostat in subjects with hypertension), 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 RWT study(Objective: To assess the efficacy of lorundrostat in subjects with hypertension by conducting a double- blind, randomized treatment withdrawal (RTW) substudy), Change from baseline to week 12 in AOBP SBP in various groups from the subjects from the parent studies (Objective: To explore the efficacy of lorundrostat at a starting dose of 25 mg QD in subjects with hypertension), Change from baseline to week 12 AOBP in subjects from various groups of the parent studies(Objective: To explore the efficacy of lorundrostat at a starting dose of 25 mg QD in subjects with hypertension), Change from MLS-101-901 baseline AOBP SBP at MLS101-901 Week 12 in subjects who were enrolled in the placebo arm of MLS-101-301 (Objective: To explore the efficacy of lorundrostat in improving BP in subjects with hypertension), Percent change in urine albumin creatinine ratio (UACR) from MLS 101 901 baseline by visit in the periods of exposure to lorundrostat during MLS-101-901 for subjects with albuminuria at the parent study baseline (Objective: To explore the efficacy of lorundrostat in improving albuminuria)

Interventions

DRUGLorundrostat Placebo tablet

Sponsors

Mineralys Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from MLS-101-301 baseline automated office blood pressure (AOBP) 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 (Objective: To assess the long-term maintenance of the AHT effect of lorundrostat in subjects with hypertension), 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 RWT study(Objective: To assess the efficacy of lorundrostat in subjects with hypertension by conducting a double- blind, randomized treatment withdrawal (RTW) substudy), Change from baseline to week 12 in AOBP SBP in various groups from the subjects from the parent studies (Objective: To explore the efficacy of lorundrostat at a starting dose of 25 mg QD in subjects with hypertension), Change from baseline to week 12 AOBP in subjects from various groups of the parent studies(Objective: To explore the efficac

Countries

Bulgaria, France, Germany, Italy, Netherlands, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026