A Study of CIN-107 in Patients With Uncontrolled Hypertension

Phase 2

Completed

Brief Summary: This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of multiple dose strengths of baxdrostat (also called CIN-107) in the treatment of patients with uncontrolled hypertension. The primary objective was to demonstrate that treatment with baxdrostat for 8 weeks would lower the systolic blood pressure (SBP) in patients who were hypertensive despite taking one or two anti-hypertensive medications.

Participants were assigned to take placebo or baxdrostat once per day for 8 weeks while they continued taking the regular anti-hypertensive medications. At the end of the 8-week period, qualified patients could participate in Part II of the study and receive 2 mg baxdrostat for 4 weeks while they discontinued taking the background anti-hypertensive medication.

Recruitment & Eligibility

Inclusion Criteria

Is on a stable regimen of background antihypertensive agent(s) for at least 8 weeks and would be considered a candidate for an additional antihypertensive agent at the time of screening ;
Has a mean seated systolic blood pressure (SBP) ≥ 140 mmHg or ≥ 130 mmHg if diabetic;
Demonstrates ability to be adherent to the study drug and their anti-hypertensive medication during a run-in period
If taking an 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 glycated 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;
White blood cell count >15 × E9/L or absolute neutrophil count <1 × E9/L at Screening;
Is positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen;
Has typical consumption of ≥14 alcoholic drinks weekly;

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks
CIN-107 0.5 mg	CIN-107	Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks
CIN-107 2 mg	CIN-107	Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks or withdraw study participation depending on BP control
CIN-107 1 mg	CIN-107	Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Seated Systolic BP (SBP)	8 weeks	The primary efficacy endpoint was the change from baseline in mean seated SBP after 8 weeks of treatment in patients with uncontrolled HTN (Part 1).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Seated Diastolic BP (DBP)	8 weeks	The change from baseline in mean seated DBP with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)
Change From Baseline in 24-hour Urine Aldosterone	8 weeks	The change from baseline in 24-hour urine aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1)
Change From Baseline in 24-hour Serum Renin	8 weeks	The change from baseline in 24-hour serum renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)
Change From Baseline in 24-hour Serum Aldosterone	8 weeks	The change from baseline in 24-hour serum aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1)
Percentage of Patients Achieving a Mean Seated SBP <130 mmHg	8 weeks	The percentage of patients achieving a mean seated SBP \<130 mmHg ("responders") with CIN-107 compared to placebo after 8 weeks of treatment (Part 1; Weeks 1 to 8)
Change From Baseline in 24-hour Urine Renin	8 weeks	The change from baseline in 24-hour urine renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)

Locations (62): CinCor Site 27
🇺🇸
Saraland, Alabama, United States
CinCor Site 35
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Tucson, Arizona, United States
CinCor Site 69
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Encinitas, California, United States
CinCor Site 6
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Lincoln, California, United States
CinCor Site 20
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Los Angeles, California, United States
CinCor Site 70
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Lynwood, California, United States
CinCor Site 36
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Northridge, California, United States
CinCor Site 29
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Oceanside, California, United States
CinCor Site 46
🇺🇸
Panorama City, California, United States
CinCor Site 47
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San Dimas, California, United States
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CinCor Site 27
🇺🇸Saraland, Alabama, United States