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

A Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Dose Strengths of CIN-107 as Compared to Placebo After 8 Weeks of Treatment in Patients With Uncontrolled Hypertension

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 249
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Saraland, Alabama, United States, 36571
      • CinCor Site 27
  • Arizona
    • Tucson, Arizona, United States, 85712
      • CinCor Site 35
  • California
    • Encinitas, California, United States, 92024
      • CinCor Site 69
    • Lincoln, California, United States, 95648
      • CinCor Site 6
    • Los Angeles, California, United States, 90057
      • CinCor Site 20
    • Lynwood, California, United States, 90262
      • CinCor Site 70
    • Northridge, California, United States, 91324
      • CinCor Site 36
    • Oceanside, California, United States, 92049
      • CinCor Site 29
    • Panorama City, California, United States, 91402
      • CinCor Site 46
    • San Dimas, California, United States, 91773
      • CinCor Site 47
    • Santa Ana, California, United States, 92705
      • CinCor Site 49
    • West Hills, California, United States, 91307
      • CinCor Site 52
  • Colorado
    • Denver, Colorado, United States, 80209
      • CinCor Site 57
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • CinCor Site 31
  • Florida
    • Clearwater, Florida, United States, 33765
      • CinCor Site 18
    • Cooper City, Florida, United States, 33024
      • CinCor Site 41
    • Homestead, Florida, United States, 33166
      • CinCor Site 28
    • Jupiter, Florida, United States, 33458
      • CinCor Site 9
    • Lake Worth, Florida, United States, 33460
      • CinCor Site 1
    • Miami, Florida, United States, 33032
      • CinCor Site 12
    • Miami, Florida, United States, 33106
      • CinCor Site 54
    • Miami, Florida, United States, 33155
      • CinCor Site 13
    • Miami, Florida, United States, 33183
      • CinCor Site 17
    • Tampa, Florida, United States, 33606
      • CinCor Site 16
    • Winter Haven, Florida, United States, 33880
      • CinCor Site 34
  • Georgia
    • Buford, Georgia, United States, 30519
      • CinCor Site 14
  • Illinois
    • Addison, Illinois, United States, 60101
      • CinCor Site 33
    • Chicago, Illinois, United States, 60607
      • CinCor Site 40
    • Gurnee, Illinois, United States, 60031
      • CinCor Site 42
    • Morton, Illinois, United States, 61550
      • CinCor Site 50
  • Indiana
    • Brownsburg, Indiana, United States, 46112
      • CinCor Site 72
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • CinCor Site 63
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • CinCor Site 7
    • Louisville, Kentucky, United States, 40213
      • CinCor Site 21
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • CinCor Site 30
    • Metairie, Louisiana, United States, 70004
      • CinCor Site 59
    • New Orleans, Louisiana, United States, 70112
      • CinCor Site 19
    • Shreveport, Louisiana, United States, 71106
      • CinCor Site 25
  • Maryland
    • Elkridge, Maryland, United States, 21043
      • CinCor Site 38
    • Elkridge, Maryland, United States, 21075
      • CinCor Site 38
  • Michigan
    • Troy, Michigan, United States, 48085
      • CinCor Site 22
  • Mississippi
    • Olive Branch, Mississippi, United States, 38654
      • CinCor Site 64
  • New York
    • Brooklyn, New York, United States, 11201
      • CinCor Site 11
    • Staten Island, New York, United States, 10305
      • CinCor Site 65
  • Ohio
    • Cincinnati, Ohio, United States, 45221
      • CinCor Site 15
    • Columbus, Ohio, United States, 43213
      • CinCor Site 24
    • Dayton, Ohio, United States, 45377
      • CinCor Site 4
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73119
      • CinCor Site 43
  • Tennessee
    • Chattanooga, Tennessee, United States, 37401
      • CinCor Site 60
  • Texas
    • Austin, Texas, United States, 78705
      • CinCor Site 48
    • Carrollton, Texas, United States, 75006
      • CinCor Site 32
    • Dallas, Texas, United States, 75234
      • CinCor Site 68
    • Georgetown, Texas, United States, 78613
      • CinCor Site 61
    • Houston, Texas, United States, 77036
      • CinCor Site 55
    • Houston, Texas, United States, 77040
      • CinCor Site 3
    • Katy, Texas, United States, 77450
      • CinCor Site 58
    • Lampasas, Texas, United States, 76550
      • CinCor Site 62
    • McAllen, Texas, United States, 78501
      • CinCor Site 26
    • San Antonio, Texas, United States, 78209
      • CinCor Site 53
    • Sugar Land, Texas, United States, 77479
      • CinCor Site 10
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • CinCor Site 45
  • Virginia
    • Manassas, Virginia, United States, 20108
      • CinCor Site 2
    • Norfolk, Virginia, United States, 23510
      • CinCor Site 5

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

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 0.5 mg; 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 tablets by mouth once daily; Other Names: Baxdrostat
Experimental: CIN-107 1 mg; 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 tablets by mouth once daily; Other Names: Baxdrostat
Experimental: CIN-107 2 mg; 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; CIN-107 tablets by mouth once daily; Other Names: Baxdrostat
Placebo Comparator: Placebo; 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; Placebo tablets by mouth once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean Seated Diastolic BP (DBP)	The change from baseline in mean seated DBP with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)	8 weeks
Change From Baseline in 24-hour Urine Aldosterone	The change from baseline in 24-hour urine aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1)	8 weeks
Change From Baseline in 24-hour Serum Aldosterone	The change from baseline in 24-hour serum aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1)	8 weeks
Percentage of Patients Achieving a Mean Seated SBP <130 mmHg	The percentage of patients achieving a mean seated SBP <130 mmHg ("responders") with CIN-107 compared to placebo after 8 weeks of treatment (Part 1; Weeks 1 to 8)	8 weeks
Change From Baseline in 24-hour Urine Renin	The change from baseline in 24-hour urine renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)	8 weeks
Change From Baseline in 24-hour Serum Renin	The change from baseline in 24-hour serum renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)	8 weeks

Collaborators and Investigators

• Sponsor: CinCor Pharma, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2021
• Primary Completion (Actual): September 13, 2022
• Study Completion (Actual): October 10, 2022

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 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-107-124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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