A Study of CIN-107 in Patients With Uncontrolled Hypertension

NCT05137002 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CIN-107-124
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 63

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.

Conditions

Uncontrolled Hypertension

Outcome Measures

Primary Outcomes (1)

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

  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).

  8 weeks

Secondary Outcomes (6)

• Change From Baseline in Mean Seated Diastolic BP (DBP)

  8 weeks

• Change From Baseline in 24-hour Urine Aldosterone

  8 weeks

• Change From Baseline in 24-hour Serum Aldosterone

  8 weeks

• Percentage of Patients Achieving a Mean Seated SBP <130 mmHg

  8 weeks

• Change From Baseline in 24-hour Urine Renin

  8 weeks

Study Arms (4)

CIN-107 0.5 mg

EXPERIMENTAL

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

Drug: CIN-107

CIN-107 1 mg

EXPERIMENTAL

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

Drug: CIN-107

CIN-107 2 mg

EXPERIMENTAL

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

Drug: CIN-107

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

CIN-107 DRUG

CIN-107 tablets by mouth once daily

Also known as: Baxdrostat

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

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 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• CinCor Pharma, Inc.: lead

Study Sites (63)

CinCor Site 27

Saraland, Alabama, 36571, United States

Location

CinCor Site 35

Tucson, Arizona, 85712, United States

Location

CinCor Site 69

Encinitas, California, 92024, United States

Location

CinCor Site 6

Lincoln, California, 95648, United States

Location

CinCor Site 20

Los Angeles, California, 90057, United States

Location

CinCor Site 70

Lynwood, California, 90262, United States

Location

CinCor Site 36

Northridge, California, 91324, United States

Location

CinCor Site 29

Oceanside, California, 92049, United States

Location

CinCor Site 46

Panorama City, California, 91402, United States

Location

CinCor Site 47

San Dimas, California, 91773, United States

Location

CinCor Site 49

Santa Ana, California, 92705, United States

Location

CinCor Site 52

West Hills, California, 91307, United States

Location

CinCor Site 57

Denver, Colorado, 80209, United States

Location

CinCor Site 31

Waterbury, Connecticut, 06708, United States

Location

CinCor Site 18

Clearwater, Florida, 33765, United States

Location

CinCor Site 41

Cooper City, Florida, 33024, United States

Location

CinCor Site 28

Homestead, Florida, 33166, United States

Location

CinCor Site 9

Jupiter, Florida, 33458, United States

Location

CinCor Site 1

Lake Worth, Florida, 33460, United States

Location

CinCor Site 12

Miami, Florida, 33032, United States

Location

CinCor Site 54

Miami, Florida, 33106, United States

Location

CinCor Site 13

Miami, Florida, 33155, United States

Location

CinCor Site 17

Miami, Florida, 33183, United States

Location

CinCor Site 16

Tampa, Florida, 33606, United States

Location

CinCor Site 34

Winter Haven, Florida, 33880, United States

Location

CinCor Site 14

Buford, Georgia, 30519, United States

Location

CinCor Site 33

Addison, Illinois, 60101, United States

Location

CinCor Site 40

Chicago, Illinois, 60607, United States

Location

CinCor Site 42

Gurnee, Illinois, 60031, United States

Location

CinCor Site 50

Morton, Illinois, 61550, United States

Location

CinCor Site 72

Brownsburg, Indiana, 46112, United States

Location

CinCor Site 63

West Des Moines, Iowa, 50266, United States

Location

CinCor Site 7

Lexington, Kentucky, 40503, United States

Location

CinCor Site 21

Louisville, Kentucky, 40213, United States

Location

CinCor Site 30

Marrero, Louisiana, 70072, United States

Location

CinCor Site 59

Metairie, Louisiana, 70004, United States

Location

CinCor Site 19

New Orleans, Louisiana, 70112, United States

Location

CinCor Site 25

Shreveport, Louisiana, 71106, United States

Location

CinCor Site 38

Elkridge, Maryland, 21043, United States

Location

CinCor Site 38

Elkridge, Maryland, 21075, United States

Location

CinCor Site 22

Troy, Michigan, 48085, United States

Location

CinCor Site 64

Olive Branch, Mississippi, 38654, United States

Location

CinCor Site 11

Brooklyn, New York, 11201, United States

Location

CinCor Site 65

Staten Island, New York, 10305, United States

Location

CinCor Site 15

Cincinnati, Ohio, 45221, United States

Location

CinCor Site 24

Columbus, Ohio, 43213, United States

Location

CinCor Site 4

Dayton, Ohio, 45377, United States

Location

CinCor Site 43

Oklahoma City, Oklahoma, 73119, United States

Location

CinCor Site 60

Chattanooga, Tennessee, 37401, United States

Location

CinCor Site 48

Austin, Texas, 78705, United States

Location

CinCor Site 32

Carrollton, Texas, 75006, United States

Location

CinCor Site 68

Dallas, Texas, 75234, United States

Location

CinCor Site 61

Georgetown, Texas, 78613, United States

Location

CinCor Site 55

Houston, Texas, 77036, United States

Location

CinCor Site 3

Houston, Texas, 77040, United States

Location

CinCor Site 58

Katy, Texas, 77450, United States

Location

CinCor Site 62

Lampasas, Texas, 76550, United States

Location

CinCor Site 26

McAllen, Texas, 78501, United States

Location

CinCor Site 53

San Antonio, Texas, 78209, United States

Location

CinCor Site 10

Sugar Land, Texas, 77479, United States

Location

CinCor Site 45

Salt Lake City, Utah, 84102, United States

Location

CinCor Site 2

Manassas, Virginia, 20108, United States

Location

CinCor Site 5

Norfolk, Virginia, 23510, United States

Location

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: November 16, 2021
• First Posted: November 30, 2021
• Study Start: December 7, 2021
• Primary Completion: September 13, 2022
• Study Completion: October 10, 2022
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (63)