A Study of CIN-107 in Patients With Uncontrolled Hypertension (HALO)

CinCor Pharma

Status and phase: Completed; Phase 2

Conditions: Uncontrolled Hypertension

Treatments: Drug: CIN-107; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05137002

CIN-107-124

Details and patient eligibility

About

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.

Enrollment: 249 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

249 participants in 4 patient groups, including a placebo group

CIN-107 0.5 mg

Experimental group

Description:

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

Treatment:

Drug: CIN-107

CIN-107 1 mg

Experimental group

Description:

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

Treatment:

Drug: CIN-107

CIN-107 2 mg

Experimental group

Description:

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

Treatment:

Drug: CIN-107

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo