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

Study Overview
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Brief Summary
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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).

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Multiple Dose Strengths of CIN-107 as Compared to Placebo After 12 Weeks of Treatment in Patients With Treatment-Resistant Hypertension (rHTN)

Conditions
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Resistant Hypertension

Intervention / Treatment
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* Drug: CIN-107
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CIN-107 0.5mg<br>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. | Drug: CIN-107<br>* CIN-107 tablets by mouth once daily<br>* Other names: baxdrostat;|
| Experimental: CIN-107 1mg<br>Subjects received CIN-107 1 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study. | Drug: CIN-107<br>* CIN-107 tablets by mouth once daily<br>* Other names: baxdrostat;|
| Experimental: CIN-107 2mg<br>Subjects received CIN-107 2 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study. | Drug: CIN-107<br>* CIN-107 tablets by mouth once daily<br>* Other names: baxdrostat;|
| Placebo Comparator: Placebo<br>Subjects received placebo tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study. | Drug: Placebo<br>* placebo tablets by mouth once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Seated Systolic BP (SBP) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Seated Diastolic BP (DBP) |  | 12 weeks | 
| The Percentage of Patients Achieving a Seated BP Response <130/80 mmHg |  | 12 weeks |