A Study of CIN-107 in Adults With Primary Aldosteronism

• Status: Recruiting
• Trial end date: 2022-03-28
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2, randomized, placebo-controlled, multicenter, parallel-group, dose-ranging study in patients with PA to evaluate the efficacy and safety of up to 3 doses of CIN-107 as compared to placebo after 4 weeks of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CinCor Pharma, Inc.

Criteria

Inclusion Criteria:

• Adults (18 years of age or older) with a diagnosis or suspected diagnosis of PA;

• Is able to wash out of protocol-specified antihypertensive medication(s) for up to 4 weeks and remain washed out for the duration of the study treatment period; and

• Is willing to take allowed, protocol-specified medication(s), if needed, to maintain BP within protocol parameters.

Exclusion Criteria:

• Has a seated SBP ≥ 180 mmHg or DBP ≥ 110 mmHg;

• Has a BMI >40 kg/m2 and an arm circumference <7 and >17 inches;

• Has had a previous surgical intervention or has a planned surgical intervention for an adrenal adenoma or adrenal carcinoma, adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the course of the study;

• Has a documented estimated glomerular filtration rate <45 mL/min/1.73m2;

• Has a planned dialysis or kidney transplantation during the course of the study;

• Has known documented chronic heart failure;

• Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before the Screening Visit;

• Has known current severe left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valvular disease, diagnosed from a prior echocardiogram;

• Has a planned or has had within 6 months of the Screening Visit a coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG]) or any major surgical procedure during the study;

• Has chronic permanent atrial fibrillation;

• Plans to be on night shifts during the course of the study;

• Has typical consumption of >14 alcoholic drinks weekly;

• Potassium <2.5 mEq/L; and,

• Potassium >5.0 mEq/L.