MLS-101-206

A PHASE 2 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LORUNDROSTAT ALONE, AND LORUNDOSTAT IN COMBINATION WITH DAPAGLIFLOZIN, IN ADULTS WITH HYPERTENSION AND CHRONIC KIDNEY DISEASE WITH ALBUMINURIA

medical-cross
Chronic kidney disease
user
All genders
person-wave 18-100
world
Recruiting now

Overview
Principal Investigator: Lesley Inker

This is a phase 2 study that evaluates Lorundrostat in adults with Hypertension, Chronic Kidney Disease, and Albuminuria.

Study details
Inclusion Criteria
  • 1. At Screening, UACR of 200-5000 mg/g, inclusive, in first morning urine void
    2. At Screening, eGFRs of ≥30 mL/min/1.73 m2
  • 3. At Screening, AOBP SBP of 135-180 mmHg, inclusive
    4. On a stable treatment with an ACEi or ARB for at least 2 months prior to Screening
  • 5. At Screening, body mass index (BMI) of >18 kg/m2
Exclusion Criteria
  • Subjects with known hypersensitivity to lorundrostat or any of its respective excipients
  • Treatment, or anticipated treatment, with triamterene and amiloride
  • Serum potassium >5.0 mmol/L at the Screening Visit and >4.8 mmol/L at Week 0 visit (prior to first dosing of study drug)
Study Requirements

10 visits in part A of assessments over the course of 26 weeks and 7 visits in part B of assessments of the course of 14 weeks. Blood draws would regularly occure.