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

NCT05968430

Active Not RecruitingPhase 3

Sponsor: Mineralys Therapeutics Inc.

Conditions: Hypertension

Interventions: lorundrostat, Placebo

Countries: United States, Australia, Bulgaria, Canada, France, Germany, Italy, Netherlands

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 (ICF)
3. Completed the EoT or EoS Visit (as applicable) in a lorundrostat study with the option of transitioning to the OLE study, in accordance with the parent study protocol
4. 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
5. Willing and able to comply with the study instructions and attend all scheduled study visits

   \[Randomized treatment withdrawal substudy only\]
6. Written informed consent to participate in the RTW substudy signed by the participant, obtained before any RTW study-related assessment is performed

Exclusion Criteria:

1. Women who are pregnant, plan to become pregnant, or are breast-feeding
2. Use, or anticipated use during the course of the study, of a prohibited medication as listed in Section 6.7.1 of the protocol
3. In the opinion of the Investigator, any condition that will preclude participation in the study

   \[Randomized treatment withdrawal substudy only\]
4. Non-compliance with study medication(s) (defined as taking \<75% or \>125% of the study drug provided) during the first 12 weeks of MLS-101-901

Locations (177)

Birmingham, Alabama, United States
Foley, Alabama, United States
Chandler, Arizona, United States
Glendale, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Beverly Hills, California, United States
Chula Vista, California, United States
Fairfield, California, United States
Granada Hills, California, United States
Huntington Beach, California, United States
La Jolla, California, United States
Lincoln, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Northridge, California, United States
Northridge, California, United States
Northridge, California, United States
Pasadena, California, United States
Pomona, California, United States
Sacramento, California, United States
San Diego, California, United States
San Jose, California, United States
Valencia, California, United States
Victorville, California, United States
Vista, California, United States
Vista, California, United States
Denver, Colorado, United States
Hamden, Connecticut, United States
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