MLS-101-901: An Open-Label Extension Study to Assess the Long-Term Safety, Efficacy, and Tolerability of Lorundrostat in Subjects with Hypertension

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Mineralys Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

26 Aug 2024 → ongoing

Decision date (initial)

2024-08-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Mineralys Therapeutics, Inc.

External identifiers

EU CT number

2023-508670-28-00

ClinicalTrials.gov

NCT05968430

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

- To assess the long-term maintenance of the antihypertensive (AHT) effect of lorundrostat in subjects with hypertension
- To assess the efficacy of lorundrostat in subjects with hypertension by conducting a double-blind, Randomized Treatment Withdrawal (RTW) substudy
- To explore the efficacy of lorundrostat at a starting dose of 25 mg once daily (QD) in subjects with hypertension
- To explore the efficacy of lorundrostat in improving blood pressure (BP) in subjects with hypertension.
- To explore the efficacy of lorundrostat in improving albuminuria
- To investigate long-term safety and tolerability of lorundrostat in subjects with hypertension

Conditions and MedDRA coding

Hypertension

Study design 3 periods

Regulatory references

Scientific advice from competent authorities

Swedish Medical Products Agency, Medicines Evaluation Board

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Written informed consent signed by the subject, obtained before any study-related assessment is performed
2. At least 18 years of age at the time of signing the ICF and capable of providing consent
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 acceptable methods 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
6. Randomized treatment withdrawal substudy only:Written informed consent to participate in the RTW substudy signed by the subject, obtained before any RTW study-related assessment is performed
7. Randomized treatment withdrawal substudy only: Completed participation in the MLS-101-301 parent study
8. Randomized treatment withdrawal substudy only:Reduction of at least 5 mmHg in AOBP SBP from the MLS-101-301 Randomization Visit value at the MLS-101-901 Week 12 Visit

Exclusion criteria 4

1. 1.Women who are pregnant, plan to become pregnant, or are breast-feeding
2. 2. Use, or anticipated use during the course of the study, of a prohibited medication as listed in Section 6.7.1
3. 3. In the opinion of the Investigator, any condition that will preclude participation in the study
4. 4.Randomized treatment withdrawal substudy only: 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 6

1. Change from MLS-101-301 baseline automated office blood pressure (AOBP) 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 (Objective: To assess the long-term maintenance of the AHT effect of lorundrostat in subjects with hypertension)
2. 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 RWT study(Objective: To assess the efficacy of lorundrostat in subjects with hypertension by conducting a double- blind, randomized treatment withdrawal (RTW) substudy)
3. Change from baseline to week 12 in AOBP SBP in various groups from the subjects from the parent studies (Objective: To explore the efficacy of lorundrostat at a starting dose of 25 mg QD in subjects with hypertension)
4. Change from baseline to week 12 AOBP in subjects from various groups of the parent studies(Objective: To explore the efficacy of lorundrostat at a starting dose of 25 mg QD in subjects with hypertension)
5. Change from MLS-101-901 baseline AOBP SBP at MLS101-901 Week 12 in subjects who were enrolled in the placebo arm of MLS-101-301 (Objective: To explore the efficacy of lorundrostat in improving BP in subjects with hypertension)
6. Percent change in urine albumin creatinine ratio (UACR) from MLS 101 901 baseline by visit in the periods of exposure to lorundrostat during MLS-101-901 for subjects with albuminuria at the parent study baseline (Objective: To explore the efficacy of lorundrostat in improving albuminuria)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Mineralys Therapeutics Inc.

Sponsor organisation

Mineralys Therapeutics Inc.

Address

150 North Radnor Chester Road Suite F200

City

Wayne

Postcode

19087-5245

Country

United States

Scientific contact point

Organisation

Mineralys Therapeutics Inc.

Contact name

David Rodman

Public contact point

Organisation

Mineralys Therapeutics Inc.

Contact name

Clinical Operations

Third parties 10

Locations

8 EU/EEA countries · 32 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Urgent safety measures 1 · Art. 54 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 149 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

16 submissions — initial application plus substantial / non-substantial modifications