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

CinCor Pharma

Status and phase: Completed; Phase 2

Conditions: Resistant Hypertension

Treatments: Drug: CIN-107; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04519658

CIN-107-121

Details and patient eligibility

About

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).

Enrollment: 275 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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275 participants in 4 patient groups, including a placebo group

CIN-107 0.5mg

Experimental group

Description:

Subjects received CIN-107 0.5 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.

Treatment:

Drug: CIN-107

CIN-107 1mg

Experimental group

Description:

Subjects received CIN-107 1 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.

Treatment:

Drug: CIN-107

CIN-107 2mg

Experimental group

Description:

Subjects received CIN-107 2 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.

Treatment:

Drug: CIN-107

Placebo

Placebo Comparator group

Description:

Subjects received placebo tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.

Treatment:

Drug: Placebo