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

  • days left to enroll
  • participants needed
  • sponsor
    CinCor Pharma, Inc.
Updated on 23 April 2022


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

Condition Uncontrolled Hypertension
Treatment Placebo, CIN-107
Clinical Study IdentifierNCT05137002
SponsorCinCor Pharma, Inc.
Last Modified on23 April 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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