A Study of CIN-107 in Adults With Treatment-Resistant Hypertension (rHTN)

• Status: Recruiting
• Trial end date: 2022-10-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled, dose-ranging Phase 2 study to evaluate the efficacy and safety of CIN-107 as compared to placebo after 12 weeks of treatment in patients with treatment-resistant hypertension (rHTN).

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

Details

• Lead Sponsor: CinCor Pharma, Inc.

Criteria

Inclusion Criteria:

• Is on a stable regimen of ≥ 3 antihypertensive agents (one of which is a diuretic) for at least 4 weeks prior to randomization;

• Be at least 70% compliant to their anti-hypertensive medication regimen;

• Has a seated BP ≥ 130/80 mmHg;

• Agrees to comply with the contraception and reproduction restrictions of the study; and

• Able to understand and willing to comply with all study visits, procedures, restrictions, and provide written informed consent according to institutional and regulatory guidelines.

Exclusion Criteria:

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

• Has a body mass index (BMI) > 40 kg/m2;

• Has an upper arm circumference < 7 or > 17 inches;

• Has been on night shifts at any time during the 4 weeks before Screening;

• Is using a beta blocker for any primary indication other than systemic hypertension (eg, migraine headache);

• Is not willing or not able to discontinue an MRA or a potassium sparing diuretic as part of an existing antihypertensive regimen;

• Is not willing or not able to discontinue taking a potassium supplement;

• Has documented estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73m2

• Has known and documented New York Heart Association stage III or IV chronic heart failure

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

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

• Major cardiac surgery (eg, CABG, valve replacement), peripheral arterial bypass surgery, or PCI within 6 months before Screening;

• Has chronic permanent atrial fibrillation;

• Has uncontrolled diabetes with glycosylated hemoglobin > 9.5% at Screening;

• Has planned dialysis or kidney transplant during the course of this study;

• Potassium < 3.5 mEq/L;

• Potassium > 5.0 mEq/L;

• Is positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen;

• Has typical consumption of ≥14 alcoholic drinks weekly.