The trial is taking place at:
E

Erie County Medical Center | Department of Medical Oncology

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

M

Mineralys Therapeutics

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Hypertension

Treatments

Drug: lorundrostat
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05968430
MLS-101-901

Details and patient eligibility

About

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

Full description

This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled hypertension. The study consists of an open-label dose treatment period of 48 weeks, followed by a 4-week double-blind randomized treatment withdrawal sub-study. The study will conclude with a 2-week wash-out period. To be eligible, subjects must complete the double-blind treatment phase of a respective parent study (including, but not limited to MLS-101-202 and MLS-101-301) and agree to transition immediately to this open-label extension (OLE) study (ie, will not participate in the end of study observation period of the parent study). The study will be conducted at approximately 200 centers.

Enrollment

900 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

900 participants in 4 patient groups, including a placebo group

Open-Label Arm
Experimental group
Description:
lorundrostat once daily for 48 weeks
Treatment:
Drug: lorundrostat
Maintenance Arm
Experimental group
Description:
lorundrostat once daily for 4 weeks in the double-blind randomized treatment withdrawal sub-study
Treatment:
Drug: lorundrostat
Taper Arm
Experimental group
Description:
lorundrostat and/or placebo once daily for 4 weeks in the double-blind randomized treatment withdrawal sub-study
Treatment:
Drug: Placebo
Drug: lorundrostat
Placebo
Placebo Comparator group
Description:
Placebo once daily for 4 weeks in the double-blind randomized treatment withdrawal sub-study
Treatment:
Drug: Placebo

Trial contacts and locations

36

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Central trial contact

Shannon Spires

Data sourced from clinicaltrials.gov

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