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Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension

NCT06153693 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1083

Last updated 2026-05-01

No results posted yet for this study

Summary

This is a Phase 3 trial to evaluate the BP-lowering effect of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive (AHT) medications.

Conditions

Interventions

DRUG

Placebo

Placebo once daily (QD) for 12 weeks

DRUG

lorundrostat Dose 1

50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks

DRUG

lorundrostat Dose 2

50 mg lorundrostat Dose 1 once daily (QD) for 6 weeks then 100 mg lorundrostat Dose 2 once daily (QD) for 6 weeks for subjects who meet prespecified criteria

Sponsors & Collaborators

  • Mineralys Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-22
Primary Completion
2024-12-10
Completion
2025-01-24
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Puerto Rico
  • Romania
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06153693 on ClinicalTrials.gov