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

NCT04519658 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CIN-107-121
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 80

Brief Summary

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).

Conditions

Resistant Hypertension

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Seated Systolic BP (SBP)

  12 weeks

Secondary Outcomes (2)

• 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

Study Arms (4)

CIN-107 0.5mg

EXPERIMENTAL

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 1mg

EXPERIMENTAL

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 2mg

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Subjects received placebo tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.

Drug: Placebo

Interventions

CIN-107 DRUG

CIN-107 tablets by mouth once daily

Also known as: baxdrostat

CIN-107 0.5mg; CIN-107 1mg; CIN-107 2mg

Placebo DRUG

placebo tablets by mouth once daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• CinCor Pharma, Inc.: lead

Study Sites (80)

CinCor Site 16

Birmingham, Alabama, 35209, United States

Location

CinCor Site 38

Birmingham, Alabama, 35294-0007, United States

Location

CinCor Site 61

Saraland, Alabama, 36571, United States

Location

CinCor Site 90

Tucson, Arizona, 85715, United States

Location

CinCor Site 82

Anaheim, California, 92805, United States

Location

CinCor Site 91

Granada Hills, California, 91344, United States

Location

CinCor Site 25

Lincoln, California, 95821, United States

Location

CinCor Site 73

Los Angeles, California, 90048, United States

Location

CinCor Site 36

Los Angeles, California, 90057, United States

Location

CinCor Site 34

Lynwood, California, 90262, United States

Location

CinCor Site 14

San Dimas, California, 91773, United States

Location

CinCor Site 28

Santa Ana, California, 92705, United States

Location

CinCor Site 19

Spring Valley, California, 91978, United States

Location

CinCor Site 32

Tustin, California, 92780, United States

Location

CinCor Site 44

West Hills, California, 91405, United States

Location

CinCor Site 66

Whittier, California, 90211, United States

Location

CinCor Site 56

Stamford, Connecticut, 06905, United States

Location

CinCor Site 30

Clearwater, Florida, 33765, United States

Location

CinCor Site 13

Fort Myers, Florida, 33912, United States

Location

CinCor Site 74

Hialeah, Florida, 33013, United States

Location

CinCor Site 22

Homestead, Florida, 33166, United States

Location

CinCor Site 20

Jacksonville, Florida, 32216, United States

Location

CinCor Site 1

Jupiter, Florida, 33458, United States

Location

CinCor Site 84

Lake Worth, Florida, 33467, United States

Location

CinCor Site 70

Miami, Florida, 33012, United States

Location

CinCor Site 89

Miami, Florida, 33032, United States

Location

CinCor Site 94

Miami, Florida, 33033, United States

Location

CinCor Site 5

Port Orange, Florida, 32127, United States

Location

CinCor Site 9

St. Petersburg, Florida, 33709, United States

Location

CinCor Site 23

Tampa, Florida, 33606, United States

Location

CinCor Site 88

Winter Haven, Florida, 33880, United States

Location

CinCor Site 71

Suwanee, Georgia, 30024, United States

Location

CinCor Site 11

Meridian, Idaho, 83642, United States

Location

CinCor Site 15

Addison, Illinois, 60101, United States

Location

CinCor Site 81

Arlington Heights, Illinois, 60005, United States

Location

CinCor Site 49

Chicago, Illinois, 60607, United States

Location

CinCor Site 35

Morton, Illinois, 61550, United States

Location

CinCor Site 58

Evansville, Indiana, 47714, United States

Location

CinCor Site 54

West Des Moines, Iowa, 50266, United States

Location

CinCor Site 29

Lexington, Kentucky, 40503, United States

Location

CinCor Site 24

Lexington, Kentucky, 40509, United States

Location

CinCor Site 69

New Orleans, Louisiana, 70119, United States

Location

CinCor Site 64

Shreveport, Louisiana, 71101, United States

Location

CinCor Site 75

Baltimore, Maryland, 21201, United States

Location

CinCor Site 65

Elkridge, Maryland, 21075, United States

Location

CinCor Site 52

Roseville, Michigan, 48066, United States

Location

CinCor Site 21

Troy, Michigan, 48085, United States

Location

CinCor Site 92

Hattiesburg, Mississippi, 39401, United States

Location

CinCor Site 50

Olive Branch, Mississippi, 38654, United States

Location

CinCor Site 45

Butte, Montana, 59701, United States

Location

CinCor Site 47

Las Vegas, Nevada, 89119, United States

Location

CinCor Site 31

Albuquerque, New Mexico, 87102, United States

Location

CinCor Site 55

Johnson City, New York, 13901, United States

Location

CinCor Site 4

The Bronx, New York, 10455, United States

Location

CinCor Site 59

Cincinnati, Ohio, 45212, United States

Location

CinCor Site 6

Cincinnati, Ohio, 45246, United States

Location

CinCor Site 7

Cincinnati, Ohio, 45246, United States

Location

CinCor Site 86

Dayton, Ohio, 45439, United States

Location

CinCor Site 43

Beaver, Pennsylvania, 15066, United States

Location

CinCor Site 39

Myrtle Beach, South Carolina, 29588, United States

Location

CinCor Site 97

Jackson, Tennessee, 38305, United States

Location

CinCor Site 42

Knoxville, Tennessee, 37920, United States

Location

CinCor Site 27

Austin, Texas, 78705, United States

Location

CinCor Site 80

Carrollton, Texas, 75006, United States

Location

CinCor Site 79

Dallas, Texas, 75234, United States

Location

CinCor Site 87

Friendswood, Texas, 77089, United States

Location

CinCor Site 2

Houston, Texas, 77040, United States

Location

CinCor Site 72

Houston, Texas, 77054, United States

Location

CinCor Site 46

Hurst, Texas, 76054, United States

Location

CinCor Site 93

Kerville, Texas, 78028, United States

Location

CinCor Site 37

McAllen, Texas, 78503, United States

Location

CinCor Site 85

Sugar Land, Texas, 77479, United States

Location

CinCor Site 48

Draper, Utah, 84020, United States

Location

CinCor Site 3

Salt Lake City, Utah, 84107, United States

Location

CinCor Site 77

Alexandria, Virginia, 22304, United States

Location

CinCor Site 8

Burke, Virginia, 22015, United States

Location

CinCor Site 33

Manassas, Virginia, 20110, United States

Location

CinCor Site 76

Norfolk, Virginia, 23510, United States

Location

CinCor Site 41

Olympia, Washington, 98502, United States

Location

CinCor Site 51

Kenosha, Wisconsin, 60031, United States

Location

Related Publications (1)

• 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.

  PMID: 36342143 BACKGROUND

Results Point of Contact

• Title: Yuan-Di Halvorsen
• Organization: CinCor Pharma

yhalvorsen@cincor.com

617-675-8126

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: October 12, 2020
• Primary Completion: June 14, 2022
• Study Completion: June 14, 2022
• Last Updated: July 24, 2023
• Results First Posted: June 28, 2023

Record last verified: 2023-07

Locations

US (80)