A Study of CIN-107 in Patients With Uncontrolled Hypertension Receiving 1 Antihypertensive Agent

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of multiple dose strengths of CIN-107 in the treatment of patients with uncontrolled hypertension who are currently taking 1 anti-hypertensive medication

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

Details

• Lead Sponsor: CinCor Pharma, Inc.
• Collaborator: CinRx

Criteria

Inclusion Criteria:

• Is on a stable regimen of a single background antihypertensive agent for at least 8 weeks and a second antihypertensive agent is warranted at the time of screening;

• Has a mean seated systolic blood pressure (SBP) ≥ 140 mmHG;

• Demonstrates they are able to be adherent to the study drug and their anti-hypertensive medication during a run-in period

• If taking SGLT2 inhibitor, the regimen must be stable for at least 8 weeks prior to randomization; and

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

Exclusion Criteria:

• Has a mean seated systolic blood pressure (SBP) ≥180 mmHG;

• Has a body mass index (BMI) >50 kg/m2;

• Is using alpha or beta blockers for any primary indication other than systemic hypertension (eg, migraine headache);

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

• Has documented estimated eGFR <30 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;

• Major cardiac surgery within 6 months before Screening;

• Has chronic permanent atrial fibrillation;

• Has uncontrolled diabetes with glycosylated hemoglobin >10% at Screening;

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

• Prior solid organ transplant and/or cell transplants;

• Sodium <130 mEq/L;

• Potassium <3.5 mEq/L;

• Potassium >5 mEq/L;

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

• Has typical consumption of ≥14 alcoholic drinks weekly;