Back to resultsOpen-Label Extension Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Uncontrolled Hypertension
Primary Purpose
Hypertension
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lorundrostat
lorundrostat
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Blood pressure, Uncontrolled hypertension, Hypertension, Hypertensive
Eligibility Criteria
Inclusion Criteria: Written informed consent signed by the participant, obtained before any study-related assessment is performed 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 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 Willing and able to comply with the study instructions and attend all scheduled study visits [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 [Randomized treatment withdrawal only] Taking an oral dose of lorundrostat of at least 25 mg once daily Exclusion Criteria: Women who are pregnant, plan to become pregnant, or are breast-feeding In the opinion of the principal investigator, any other condition that will preclude participation in the study
Sites / Locations
- Del Sol Research Management, LLCRecruiting
- CMR of Greater New HavenRecruiting
- Nuovida Research Center CorpRecruiting
- Patron Medical - Andres Patron D.O. (Patron Ventures, LLC)Recruiting
- Clinical Research of West Florida, Inc.Recruiting
- Georgia Clinical Research, LLCRecruiting
- Triad Internal MedicineRecruiting
- Lucas ResearchRecruiting
- Synergy Groups Medical - Bissonet SiteRecruiting
- Juno Research, LLCRecruiting
- Clinical Investigations of Texas (CIT)Recruiting
- Burke Internal MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Open-Label Arm
Maintenance Arm
Taper Arm
Placebo
Arm Description
lorundrostat once daily for 48 weeks
lorundrostat once daily for 4 weeks in the double-blind randomized treatment withdrawal sub-study
lorundrostat and/or placebo once daily for 4 weeks in the double-blind randomized treatment withdrawal sub-study
Placebo once daily for 4 weeks in the double-blind randomized treatment withdrawal sub-study
Outcomes
Primary Outcome Measures
Change in automated office blood pressure (AOBP) systolic blood pressure (SBP)
Secondary Outcome Measures
Change in AOBP SBP in subjects taking lorundrostat at study entry
Change in AOBP SBP in subjects taking placebo at study entry
Change in AOBP diastolic blood pressure (DBP) in subjects taking lorundrostat at study entry
Change in AOBP DBP in subjects taking placebo at study entry
Proportion of subjects with AOBP SBP ≤130 mmHg at each visit
Proportion of subjects with AOBP ≤130/80 mmHg at each visit
In subjects participating in the randomized withdrawal sub-study, change in AOBP SBP
In subjects participating in the randomized withdrawal sub-study, change in AOBP DBP
Full Information
NCT ID
NCT05968430
First Posted
July 14, 2023
Last Updated
October 20, 2023
Sponsor
Mineralys Therapeutics Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05968430
Brief Title
Open-Label Extension Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Uncontrolled Hypertension
Official Title
An Open-Label Extension Study to Assess the Long-Term Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Uncontrolled Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mineralys Therapeutics Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled hypertension.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Blood pressure, Uncontrolled hypertension, Hypertension, Hypertensive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Double
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open-Label Arm
Arm Type
Experimental
Arm Description
lorundrostat once daily for 48 weeks
Arm Title
Maintenance Arm
Arm Type
Experimental
Arm Description
lorundrostat once daily for 4 weeks in the double-blind randomized treatment withdrawal sub-study
Arm Title
Taper Arm
Arm Type
Experimental
Arm Description
lorundrostat and/or placebo once daily for 4 weeks in the double-blind randomized treatment withdrawal sub-study
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once daily for 4 weeks in the double-blind randomized treatment withdrawal sub-study
Intervention Type
Drug
Intervention Name(s)
lorundrostat
Intervention Description
lorundrostat once daily for 48 weeks
Intervention Type
Drug
Intervention Name(s)
lorundrostat
Intervention Description
lorundrostat once daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily for 4 weeks
Primary Outcome Measure Information:
Title
Change in automated office blood pressure (AOBP) systolic blood pressure (SBP)
Time Frame
Week 16 to Week 48
Secondary Outcome Measure Information:
Title
Change in AOBP SBP in subjects taking lorundrostat at study entry
Time Frame
Week 0 - 48
Title
Change in AOBP SBP in subjects taking placebo at study entry
Time Frame
Week 16 - 48
Title
Change in AOBP diastolic blood pressure (DBP) in subjects taking lorundrostat at study entry
Time Frame
Week 0 - 48
Title
Change in AOBP DBP in subjects taking placebo at study entry
Time Frame
Week 16 - 48
Title
Proportion of subjects with AOBP SBP ≤130 mmHg at each visit
Time Frame
Through study completion, up to 54 weeks
Title
Proportion of subjects with AOBP ≤130/80 mmHg at each visit
Time Frame
Through study completion, up to 54 weeks
Title
In subjects participating in the randomized withdrawal sub-study, change in AOBP SBP
Time Frame
Week 48 to Week 52
Title
In subjects participating in the randomized withdrawal sub-study, change in AOBP DBP
Time Frame
Week 48 to Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent signed by the participant, obtained before any study-related assessment is performed
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
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
Willing and able to comply with the study instructions and attend all scheduled study visits
[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
[Randomized treatment withdrawal only] Taking an oral dose of lorundrostat of at least 25 mg once daily
Exclusion Criteria:
Women who are pregnant, plan to become pregnant, or are breast-feeding
In the opinion of the principal investigator, any other condition that will preclude participation in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shannon Spires
Phone
905-626-1111
Email
sspires@mineralystx.com
Facility Information:
Facility Name
Del Sol Research Management, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl Diener
Phone
520-257-3881
Email
cdiener@delsolresearch.com
Facility Name
CMR of Greater New Haven
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06512
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Soufer, MD
Phone
203-373-4373
Email
jsoufer@chasemr.com
Facility Name
Nuovida Research Center Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Diaz-Secades
Phone
305-903-2411
Email
diazsecade@gmail.com
Facility Name
Patron Medical - Andres Patron D.O. (Patron Ventures, LLC)
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andres Patron, DO
Phone
954-885-5555
Email
apatron@patronmedical.com
Facility Name
Clinical Research of West Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lon Lynn
Phone
813-264-7922
Email
LLynn@crwf.com
Facility Name
Georgia Clinical Research, LLC
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30044
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Lentz, MD
Phone
678-822-5581
Email
georgiaclinicalresearch@comcast.ne
Facility Name
Triad Internal Medicine
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keung Lee
Phone
336-625-2333
Email
leefamily877@yahoo.com
Facility Name
Lucas Research
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Presswood, Dr
Phone
252-649-1944
Email
Claire.presswood@lucasresearch.org
Facility Name
Synergy Groups Medical - Bissonet Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dilawar Ajani
Phone
832-287-0200
Email
dajani@synergygroupus.com
Facility Name
Juno Research, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rocio Harbison
Phone
713-779-5494
Email
Rocio_harbison@junoresearch.us
Facility Name
Clinical Investigations of Texas (CIT)
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fehmida Zahabi
Phone
972-599-1530
Email
Fehmida.zahabi@clinicalinvestigationsoftexas.com
Facility Name
Burke Internal Medicine
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashwa Gabra
Phone
703-455-9711
Email
nashwagabra@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Open-Label Extension Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Uncontrolled Hypertension
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