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

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled hypertension.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mineralys Therapeutics Inc.

Criteria

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 Participation in a lorundrostat study with the option of transitioning to the OLE study

3. 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

4. Willing and able to comply with the study instructions and attend all scheduled study visits

5. [Randomized treatment withdrawal only] A minimum of 75% and a maximum of 125% compliance with lorundrostat from Week 32 to Week 48 of the OLE

6. [Randomized treatment withdrawal only] Taking an oral dose of lorundrostat of at least 25 mg once daily

Exclusion Criteria:

1. Women who are pregnant, plan to become pregnant, or are breast-feeding

2. In the opinion of the principal investigator, any other condition that will preclude participation in the study