ClinicalTrials.Veeva

Menu
The trial is taking place at:
S

Saint Louis University | SLUCare Academic Pavilion - Endocrinology Division Research

Veeva-enabled site

A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects with Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen

M

Mineralys Therapeutics

Status and phase

Active, not recruiting
Phase 2

Conditions

Hypertension

Treatments

Drug: Placebo
Drug: lorundrostat Dose 2
Drug: lorundrostat Dose 1

Study type

Interventional

Funder types

Industry

Identifiers

NCT05769608
MLS-101-202

Details and patient eligibility

About

A Phase 2 trial to evaluate the blood pressure-lowering effect of lorundrostat an aldosterone synthase inhibitor (ASI), administered as an add-on to a standardized anti-hypertensive (AHT) medication regimen, in subjects with hypertension.

Full description

This study is a Phase 2 trial to evaluate the blood pressure-lowering effects of lorundrostat (an ASI), administered as add-on to a standardized anti-hypertensive (AHT) medication regimen, in subjects with hypertension.

The study consists of a standardized AHT regimen run-in period followed by a randomized, double-blind, placebo-controlled, parallel arm period. Following the double-blind period subjects may be offered the opportunity to participate in an open-label extension (OLE) study. Subjects electing to not participate in the OLE will undergo an end of study (EoS) visit approximately 2 weeks after the last dose of study drug to complete their participation in the study.

Enrollment

285 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. At least 18 years of age at the time of signing the informed consent form
  2. At Screening: AOBP SBP of 140-180 mmHg and AOBP DBP of 65-110 mmHg, or AOBP DBP of 90-110 mmHg
  3. 24-hour average ABPM SBP of 130-180 mmHg or 24-hour average ABPM DBP >80 mmHg
  4. Taking between 2 and 5 AHT medications, inclusive, at Screening visit.
  5. BMI of 18-40 kg/m2 inclusive at Screening

Exclusion criteria

  1. eGFR <45 mL/min/1.73 m2 at Screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
  2. Serum potassium >5.0 mmol/L at Screening or >4.8 mmol/L at Randomization
  3. Serum sodium <135 mmol/L at Screening
  4. History of heart failure, myocardial infarction, stroke, or transient ischemic attack within 6 months prior to Screening.
  5. Diabetes mellitus with a glycosylated hemoglobin (HbA1c) >9% (>74.9 mmol/mol) at Screening

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

285 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Placebo once daily for 12 weeks
Treatment:
Drug: Placebo
Dose 1
Experimental group
Description:
lorundrostat Dose 1 once daily for 12 weeks
Treatment:
Drug: lorundrostat Dose 1
Dose 2
Experimental group
Description:
lorundrostat Dose 1 once daily for 4 weeks then lorundrostat Dose 2 once daily for 8 weeks
Treatment:
Drug: lorundrostat Dose 2

Trial contacts and locations

105

Loading...

Central trial contact

Jessica Tesoriero

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems