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

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)

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).

Study Overview

• Status: Completed
• Conditions: Resistant Hypertension
• Intervention / Treatment: Drug: CIN-107; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 275
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • CinCor Site 16
    • Birmingham, Alabama, United States, 35294-0007
      • CinCor Site 38
    • Saraland, Alabama, United States, 36571
      • CinCor Site 61
  • Arizona
    • Tucson, Arizona, United States, 85715
      • CinCor Site 90
  • California
    • Anaheim, California, United States, 92805
      • CinCor Site 82
    • Granada Hills, California, United States, 91344
      • CinCor Site 91
    • Lincoln, California, United States, 95821
      • CinCor Site 25
    • Los Angeles, California, United States, 90048
      • CinCor Site 73
    • Los Angeles, California, United States, 90057
      • CinCor Site 36
    • Lynwood, California, United States, 90262
      • CinCor Site 34
    • San Dimas, California, United States, 91773
      • CinCor Site 14
    • Santa Ana, California, United States, 92705
      • CinCor Site 28
    • Spring Valley, California, United States, 91978
      • CinCor Site 19
    • Tustin, California, United States, 92780
      • CinCor Site 32
    • West Hills, California, United States, 91405
      • CinCor Site 44
    • Whittier, California, United States, 90211
      • CinCor Site 66
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • CinCor Site 56
  • Florida
    • Clearwater, Florida, United States, 33765
      • CinCor Site 30
    • Fort Myers, Florida, United States, 33912
      • CinCor Site 13
    • Hialeah, Florida, United States, 33013
      • CinCor Site 74
    • Homestead, Florida, United States, 33166
      • CinCor Site 22
    • Jacksonville, Florida, United States, 32216
      • CinCor Site 20
    • Jupiter, Florida, United States, 33458
      • CinCor Site 1
    • Lake Worth, Florida, United States, 33467
      • CinCor Site 84
    • Miami, Florida, United States, 33012
      • CinCor Site 70
    • Miami, Florida, United States, 33032
      • CinCor Site 89
    • Miami, Florida, United States, 33033
      • CinCor Site 94
    • Port Orange, Florida, United States, 32127
      • CinCor Site 5
    • Saint Petersburg, Florida, United States, 33709
      • CinCor Site 9
    • Tampa, Florida, United States, 33606
      • CinCor Site 23
    • Winter Haven, Florida, United States, 33880
      • CinCor Site 88
  • Georgia
    • Suwanee, Georgia, United States, 30024
      • CinCor Site 71
  • Idaho
    • Meridian, Idaho, United States, 83642
      • CinCor Site 11
  • Illinois
    • Addison, Illinois, United States, 60101
      • CinCor Site 15
    • Arlington Heights, Illinois, United States, 60005
      • CinCor Site 81
    • Chicago, Illinois, United States, 60607
      • CinCor Site 49
    • Morton, Illinois, United States, 61550
      • CinCor Site 35
  • Indiana
    • Evansville, Indiana, United States, 47714
      • CinCor Site 58
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • CinCor Site 54
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • CinCor Site 29
    • Lexington, Kentucky, United States, 40509
      • CinCor Site 24
  • Louisiana
    • New Orleans, Louisiana, United States, 70119
      • CinCor Site 69
    • Shreveport, Louisiana, United States, 71101
      • CinCor Site 64
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • CinCor Site 75
    • Elkridge, Maryland, United States, 21075
      • CinCor Site 65
  • Michigan
    • Roseville, Michigan, United States, 48066
      • CinCor Site 52
    • Troy, Michigan, United States, 48085
      • CinCor Site 21
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • CinCor Site 92
    • Olive Branch, Mississippi, United States, 38654
      • CinCor Site 50
  • Montana
    • Butte, Montana, United States, 59701
      • CinCor Site 45
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • CinCor Site 47
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • CinCor Site 31
  • New York
    • Bronx, New York, United States, 10455
      • CinCor Site 4
    • Johnson City, New York, United States, 13901
      • CinCor Site 55
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • CinCor Site 59
    • Cincinnati, Ohio, United States, 45246
      • CinCor Site 6
    • Cincinnati, Ohio, United States, 45246
      • CinCor Site 7
    • Dayton, Ohio, United States, 45439
      • CinCor Site 86
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15066
      • CinCor Site 43
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29588
      • CinCor Site 39
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • CinCor Site 97
    • Knoxville, Tennessee, United States, 37920
      • CinCor Site 42
  • Texas
    • Austin, Texas, United States, 78705
      • CinCor Site 27
    • Carrollton, Texas, United States, 75006
      • CinCor Site 80
    • Dallas, Texas, United States, 75234
      • CinCor Site 79
    • Friendswood, Texas, United States, 77089
      • CinCor Site 87
    • Houston, Texas, United States, 77040
      • CinCor Site 2
    • Houston, Texas, United States, 77054
      • CinCor Site 72
    • Hurst, Texas, United States, 76054
      • CinCor Site 46
    • Kerville, Texas, United States, 78028
      • CinCor Site 93
    • McAllen, Texas, United States, 78503
      • CinCor Site 37
    • Sugar Land, Texas, United States, 77479
      • CinCor Site 85
  • Utah
    • Draper, Utah, United States, 84020
      • CinCor Site 48
    • Salt Lake City, Utah, United States, 84107
      • CinCor Site 3
  • Virginia
    • Alexandria, Virginia, United States, 22304
      • CinCor Site 77
    • Burke, Virginia, United States, 22015
      • CinCor Site 8
    • Manassas, Virginia, United States, 20110
      • CinCor Site 33
    • Norfolk, Virginia, United States, 23510
      • CinCor Site 76
  • Washington
    • Olympia, Washington, United States, 98502
      • CinCor Site 41
  • Wisconsin
    • Kenosha, Wisconsin, United States, 60031
      • CinCor Site 51

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: CinCor Pharma, Inc.

Publications and helpful links

General Publications

• Freeman MW, Halvorsen YD, Marshall W, Pater M, Isaacsohn J, Pearce C, Murphy B, Alp N, Srivastava A, Bhatt DL, Brown MJ; BrigHTN Investigators. Phase 2 Trial of Baxdrostat for Treatment-Resistant Hypertension. N Engl J Med. 2023 Feb 2;388(5):395-405. doi: 10.1056/NEJMoa2213169. Epub 2022 Nov 7.

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2020
• Primary Completion (Actual): June 14, 2022
• Study Completion (Actual): June 14, 2022

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: CIN-107-121

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No