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Aldosterone Synthase Inhibitor

Lorundrostat + Dapagliflozin for Kidney Disease

Phase 2
Recruiting
Research Sponsored by Mineralys Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12 to week 20

Summary

This trial is being conducted to evaluate how well a medication called lorundrostat works in treating high blood pressure in people with chronic kidney disease (CKD) and high levels of a protein called album

Who is the study for?
This trial is for adults with chronic kidney disease and high levels of protein in their urine (albuminuria), who also have high blood pressure. They should be on stable heart medication (ACEi or ARB) for at least 2 months, with specific ranges of kidney function and body mass index.
What is being tested?
The study tests Lorundrostat, a drug that may help control blood pressure by inhibiting aldosterone production, alone or combined with Dapagliflozin. It's divided into two parts to assess effectiveness and safety in different stages of kidney disease.
What are the potential side effects?
Possible side effects include changes in blood pressure, electrolyte imbalances like high potassium levels, dizziness due to low blood pressure, potential worsening of kidney function, and typical drug-related reactions such as nausea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12 to week 20
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 to week 20 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Part A: Change from Week 12 in AOBP SBP at Week 20
Part A: Percent change from baseline in 24-hour urine albumin to creatinine ratio (UACR) at Week 8

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
Group II: Cohort 1Experimental Treatment1 Intervention

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Who is running the clinical trial?

Mineralys Therapeutics Inc.Lead Sponsor
4 Previous Clinical Trials
2,400 Total Patients Enrolled
~31 spots leftby Nov 2025
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