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

April 23, 2024 updated by: Mineralys Therapeutics Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

900

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
    • California
      • Huntington Beach, California, United States, 92647
        • Recruiting
        • Marvel Clinical Research 002, LLC
        • Contact:
      • Lincoln, California, United States, 95648
        • Recruiting
        • Clinical Trials Research (CTR) - Lincoln
        • Contact:
      • Vista, California, United States, 92081
    • Connecticut
      • Hamden, Connecticut, United States, 06512
        • Recruiting
        • CMR of Greater New Haven
        • Contact:
    • Florida
      • Hialeah, Florida, United States, 33012
      • Miami, Florida, United States, 33186
        • Recruiting
        • Nuovida Research Center Corp
        • Contact:
      • Orlando, Florida, United States, 32801
      • Pembroke Pines, Florida, United States, 33026
        • Recruiting
        • Patron Medical - Andres Patron D.O. (Patron Ventures, LLC)
        • Contact:
      • Port Orange, Florida, United States, 32127
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Clinical Research of West Florida, Inc.
        • Contact:
    • Georgia
      • Decatur, Georgia, United States, 30030
      • Lawrenceville, Georgia, United States, 30044
    • Kentucky
    • Massachusetts
      • Methuen, Massachusetts, United States, 01844
    • New York
      • Albany, New York, United States, 12203
        • Recruiting
        • Albany Medical College
        • Contact:
      • Buffalo, New York, United States, 14215
        • Recruiting
        • Erie County Medical Center
        • Contact:
    • North Carolina
      • Asheboro, North Carolina, United States, 27205
        • Recruiting
        • Triad Internal Medicine
        • Contact:
      • New Bern, North Carolina, United States, 28562
    • Ohio
      • Canton, Ohio, United States, 44240
        • Recruiting
        • Diabetes & Endocrinology Associates of Stark County
        • Contact:
      • Vandalia, Ohio, United States, 45377
        • Recruiting
        • Arthritis & Osteoarthritis Center of SW Ohio/ dba STAT Research
        • Contact:
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Recruiting
        • Willamette Valley Clinical Studies
        • Contact:
    • South Carolina
      • North Charleston, South Carolina, United States, 29405
        • Recruiting
        • Coastal Carolina Research Center
        • Contact:
    • Tennessee
      • Memphis, Tennessee, United States, 38119
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center (VUMC)
        • Contact:
    • Texas
      • Carrollton, Texas, United States, 75006
        • Recruiting
        • Punzi Medical Center
        • Contact:
      • Houston, Texas, United States, 77054
      • Houston, Texas, United States, 77036
        • Recruiting
        • Synergy Groups Medical - Bissonet Site
        • Contact:
      • Plano, Texas, United States, 75075
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • Sun Research Institute (SRI) - San Antonio
        • Contact:
    • Virginia
      • Burke, Virginia, United States, 22015
        • Recruiting
        • Burke Internal Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in automated office blood pressure (AOBP) systolic blood pressure (SBP)
Time Frame: Week 16 to Week 48
Week 16 to Week 48

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in AOBP SBP in subjects taking lorundrostat at study entry
Time Frame: Week 0 - 48
Week 0 - 48
Change in AOBP SBP in subjects taking placebo at study entry
Time Frame: Week 16 - 48
Week 16 - 48
Change in AOBP diastolic blood pressure (DBP) in subjects taking lorundrostat at study entry
Time Frame: Week 0 - 48
Week 0 - 48
Change in AOBP DBP in subjects taking placebo at study entry
Time Frame: Week 16 - 48
Week 16 - 48
Proportion of subjects with AOBP SBP ≤130 mmHg at each visit
Time Frame: Through study completion, up to 54 weeks
Through study completion, up to 54 weeks
Proportion of subjects with AOBP ≤130/80 mmHg at each visit
Time Frame: Through study completion, up to 54 weeks
Through study completion, up to 54 weeks
In subjects participating in the randomized withdrawal sub-study, change in AOBP SBP
Time Frame: Week 48 to Week 52
Week 48 to Week 52
In subjects participating in the randomized withdrawal sub-study, change in AOBP DBP
Time Frame: Week 48 to Week 52
Week 48 to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mineralys Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 14, 2023

First Submitted That Met QC Criteria

July 26, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MLS-101-901

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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