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

Mineralys Therapeutics

Status and phase: Invitation-only; Phase 3

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 hypertension

Full 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 up to 36 or 48-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 can remain on study until marketing authorization or early termination of the trial by the sponsor.

Enrollment: 1,400 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 (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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,400 participants in 3 patient groups

Open-Label Arm

Experimental group

Description:

lorundrostat once daily for 36 or 48 weeks depending on when the subject enrolled

Treatment:

Drug: lorundrostat

RTW Substudy

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: lorundrostat

Optional Continuation Period

Experimental group

Description:

lorundrostat once daily from weeks 36 or 48 until marketing authorization or early termination of the trial by the sponsor

Treatment:

Drug: lorundrostat