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NCT05968430 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
A Phase 3 study of Hypertension, sponsored by Mineralys Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 1,076
- Enrollment target
- 20
- Study locations
NCT05968430: Active Phase 3 study of Hypertension, sponsored by Mineralys Therapeutics.
NCT05968430 is a Phase 3 study of Hypertension that is active but no longer recruiting, run by Mineralys Therapeutics. The registered enrollment target is 1,076 participants, below the 3,505-participant average among 470 other Hypertension trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05968430, a Phase 3 study of Hypertension, is active but no longer recruiting, sponsored by Mineralys Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,076 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG lorundrostat
Study Locations (20)
California
- Entertainment Medical Group, Inc - Beverly Hills
- CA Institute of Renal Research, CA - Chula Vista
- Amicis Research Center - Vacaville - Fairfield
- Amicis Research Center - Granada Hills - Granada Hills
- Marvel Clinical Research 002, LLC - Huntington Beach
- University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI) - La Jolla
- Clinical Trials Research (CTR) - Lincoln - Lincoln
- Academic Medical Research Institute (AMRI) - Los Angeles - Los Angeles
- Cedars-Sinai Medical Center - Los Angeles
- Amicis Research Center - Mission Hills - Northridge
- Amicis Research Center-Northridge - Northridge
- Northridge Clinical Trials - Northridge
- Pasadena Clinical Trials - Pasadena
Arizona
- Chandler Clinical Trials - Chandler
- Arizona Kidney - Glendale
- AKDHC Medical Research Services, AZ - Phoenix
- Noble Clinical Research - Tucson
- Del Sol Research Management, LLC - Tucson
Alabama
- Accel Research Sites (ARS) - Birmingham Clinical Research Unit - Birmingham
- G & L Research LLC - Foley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,076 participants |
| Start Date | 2023-07-14 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
What the registry record for NCT05968430 still lists
NCT05968430 is an interventional study that assigns participants to a tested intervention. Its 1,076 participants enrollment target places it among the larger protocols in the corpus, below the 3,505-participant average among 470 other Hypertension trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05968430 names 20 study sites across 3 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT05968430 about?
NCT05968430 is a clinical study titled "Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension". This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension
What is the current status of trial NCT05968430?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,076 participants. The study started on 2023-07-14. Estimated completion is 2026-12.
What conditions does trial NCT05968430 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT05968430?
The interventions under investigation include: Placebo (DRUG), lorundrostat (DRUG).
Who is sponsoring clinical trial NCT05968430?
This trial is sponsored by Mineralys Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05968430 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypertension
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05968430's enrollment target sits among peer trials
1,076 63rd of 470 higher than 408 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening)
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