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

Sponsor
CinCor Pharma, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05137002
Collaborator
(none)
212
Enrollment
63
Locations
4
Arms
9
Anticipated Duration (Months)
3.4
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
212 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Dec 7, 2021
Anticipated Primary Completion Date :
Sep 6, 2022
Anticipated Study Completion Date :
Sep 6, 2022

Arms and Interventions

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
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
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
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

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in mean seated systolic BP (SBP) [8 weeks]

Secondary Outcome Measures

  1. Change from baseline in mean seated diastolic BP (DBP) [8 weeks]

  2. Change from baseline in 24-hour urine aldosterone and serum aldosterone [8 weeks]

  3. Percentage of patients achieving a mean seated SBP <130 mmHg [8 weeks]

  4. Change from baseline in 24-hour urine renin and serum renin [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

  • 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;

  • 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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 CinCor Site 27 Saraland Alabama United States 36571
2 CinCor Site 35 Tucson Arizona United States 85712
3 CinCor Site 69 Encinitas California United States 92024
4 CinCor Site 6 Lincoln California United States 95648
5 CinCor Site 20 Los Angeles California United States 90057
6 CinCor Site 70 Lynwood California United States 90262
7 CinCor Site 36 Northridge California United States 91324
8 CinCor Site 29 Oceanside California United States 92049
9 CinCor Site 46 Panorama City California United States 91402
10 CinCor Site 47 San Dimas California United States 91773
11 CinCor Site 49 Santa Ana California United States 92705
12 CinCor Site 52 West Hills California United States 91307
13 CinCor Site 57 Denver Colorado United States 80209
14 CinCor Site 31 Waterbury Connecticut United States 06708
15 CinCor Site 18 Clearwater Florida United States 33765
16 CinCor Site 41 Cooper City Florida United States 33024
17 CinCor Site 9 Jupiter Florida United States 33458
18 CinCor Site 1 Lake Worth Florida United States 33460
19 CinCor Site 12 Miami Florida United States 33032
20 CinCor Site 54 Miami Florida United States 33106
21 CinCor Site 13 Miami Florida United States 33155
22 CinCor Site 17 Miami Florida United States 33183
23 CinCor Site 16 Tampa Florida United States 33606
24 CinCor Site 34 Winter Haven Florida United States 33880
25 CinCor Site 14 Buford Georgia United States 30519
26 CinCor Site 72 Brownsburg Indiana United States 46112
27 CinCor Site 63 West Des Moines Iowa United States 50266
28 CinCor Site 7 Lexington Kentucky United States 40503
29 CinCor Site 21 Louisville Kentucky United States 40213
30 CinCor Site 30 Marrero Louisiana United States 70072
31 CinCor Site 59 Metairie Louisiana United States 70004
32 CinCor Site 19 New Orleans Louisiana United States 70112
33 CinCor Site 25 Shreveport Louisiana United States 71106
34 CinCor Site 38 Elkridge Maryland United States 21043
35 CinCor Site 38 Elkridge Maryland United States 21075
36 CinCor Site 22 Troy Michigan United States 48085
37 CinCor Site 11 Brooklyn New York United States 11201
38 CinCor Site 65 Staten Island New York United States 10305
39 CinCor Site 15 Cincinnati Ohio United States 45221
40 CinCor Site 28 Cincinnati Ohio United States 45221
41 CinCor Site 33 Cincinnati Ohio United States 45221
42 CinCor Site 40 Cincinnati Ohio United States 45221
43 CinCor Site 42 Cincinnati Ohio United States 45221
44 CinCor Site 50 Cincinnati Ohio United States 45521
45 CinCor Site 24 Columbus Ohio United States 43213
46 CinCor Site 4 Dayton Ohio United States 45377
47 CinCor Site 43 Oklahoma City Oklahoma United States 73119
48 CinCor Site 60 Chattanooga Tennessee United States 37401
49 CinCor Site 48 Austin Texas United States 78705
50 CinCor Site 32 Carrollton Texas United States 75006
51 CinCor Site 68 Dallas Texas United States 75234
52 CinCor Site 55 Houston Texas United States 77036
53 CinCor Site 3 Houston Texas United States 77040
54 CinCor Site 61 Irving Texas United States 75062
55 CinCor Site 58 Katy Texas United States 77450
56 CinCor Site 62 Lampasas Texas United States 76550
57 CinCor Site 64 Lampasas Texas United States 76550
58 CinCor Site 26 McAllen Texas United States 78501
59 CinCor Site 53 San Antonio Texas United States 78209
60 CinCor Site 10 Sugar Land Texas United States 77479
61 CinCor Site 45 Salt Lake City Utah United States 84102
62 CinCor Site 2 Manassas Virginia United States 20108
63 CinCor Site 5 Norfolk Virginia United States 23510

Sponsors and Collaborators

  • CinCor Pharma, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CinCor Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT05137002
Other Study ID Numbers:
  • CIN-107-124
First Posted:
Nov 30, 2021
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hypertension

Study Results

No Results Posted as of Jun 22, 2022