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

Phase 3

Active, not recruiting

• Conditions: Hypertension
• Interventions: Drug: lorundrostat; Drug: Placebo

• Registration Number: NCT05968430
• Lead Sponsor: Mineralys Therapeutics Inc.

Brief Summary

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

Detailed Description

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

This study consists of an open label treatment period of 52 weeks followed by a 2-week safety follow-up period. Eligible subjects for MLS-101-901 are those who were enrolled in one of the eligible parent studies, meet the eligibility criteria for this protocol, and agree, by signing an informed consent form (ICF), to transition to this open label extension (OLE) study at either the end-of-study (EoS) visit or the end-of-treatment (EoT) visit as required in the parent study protocol.

A Randomized Treatment Withdrawal (RTW) substudy will be performed in a subset of subjects meeting eligibility criteria.

Subjects who complete the open label treatment period will be invited to consent to an optional continuation period where they may remain on study until marketing authorization or early termination of the trial by the sponsor.

Study Timeline

• Study Start: 2023-07-14
• Study First Submitted: 2023-07-14
• Study First Submitted QC: 2023-07-26
• Study First Posted: 2023-08-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-12
• Last Update Posted: 2025-06-15
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-Label Arm	lorundrostat	lorundrostat once daily for 52 weeks depending on when the subject enrolled
RTW Substudy	lorundrostat	lorundrostat or placebo once daily for 4 weeks starting at week 12, in the double-blind randomized treatment withdrawal substudy Optional for subjects from the MLS-101-301 parent study only
RTW Substudy	Placebo	lorundrostat or placebo once daily for 4 weeks starting at week 12, in the double-blind randomized treatment withdrawal substudy Optional for subjects from the MLS-101-301 parent study only
Optional Continuation Period	lorundrostat	lorundrostat once daily from week 52 or until marketing authorization or early termination of the trial by the sponsor

Primary Outcome Measures

Name	Time	Method
Change from MLS-101-301 baseline automated office blood pressure	Week 36	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
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 RTW	Week 16

Trial Locations

Locations (173)

Accel Research Sites (ARS) - Birmingham Clinical Research Unit; 🇺🇸 Birmingham, Alabama, United States

G & L Research LLC; 🇺🇸 Foley, Alabama, United States

Chandler Clinical Trials; 🇺🇸 Chandler, Arizona, United States

Arizona Kidney; 🇺🇸 Glendale, Arizona, United States

AKDHC Medical Research Services, AZ; 🇺🇸 Phoenix, Arizona, United States

Noble Clinical Research; 🇺🇸 Tucson, Arizona, United States

Del Sol Research Management, LLC; 🇺🇸 Tucson, Arizona, United States

Entertainment Medical Group, Inc; 🇺🇸 Beverly Hills, California, United States

CA Institute of Renal Research, CA; 🇺🇸 Chula Vista, California, United States

Amicis Research Center - Vacaville; 🇺🇸 Fairfield, California, United States

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