A Study of CIN-107 in Adults With Primary Aldosteronism

Sponsor
CinCor Pharma, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04605549
Collaborator
(none)
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Study Details

Study Description

Brief Summary

This is a multicenter, open-label study in adult patients with PA to evaluate the effectiveness and safety of CIN-107 after up to 12 weeks of treatment, at doses from 2 to 8 mg per day, for the management of blood pressure in patients with primary aldosteronism (PA).

Condition or Disease Intervention/Treatment Phase
  • Drug: CIN-107 2 mg dosing
  • Drug: CIN-107 4 mg dosing
  • Drug: CIN-107 8 mg dosing
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Effectiveness of CIN-107 for the Management of Blood Pressure in Patients With Primary Aldosteronism
Actual Study Start Date :
Jan 13, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: CIN-107 for dosing at 2, 4, or 8 mg

Patients will be provided with an initial dose of CIN-107 and start once daily (QD) dosing of CIN-107 tablets at 2 mg. At Visit 4, CIN-107 dose may be up-titrated to 4 mg QD if the patient has tolerated dosing of CIN-107 at 2 mg and the blood pressure (BP) records indicate minimal hypotension risk. At Visit 5, CIN-107 dose may be up-titrated to 8 mg QD if the patient has tolerated dosing of CIN-107 at 4 mg.

Drug: CIN-107 2 mg dosing
One tablet of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 2 mg.

Drug: CIN-107 4 mg dosing
Two tablets of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 4 mg.

Drug: CIN-107 8 mg dosing
Four tablets of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 8 mg.

Outcome Measures

Primary Outcome Measures

  1. Number of participants with Adverse Events (AEs) [14 Weeks]

    Outcome measure is overall safety with is a composite of the following individual parameters (unit of measure in brackets): Adverse Events [number of events]; ECGs [PR interval (msec), RR interval (msec), or QTcF interval (msec); clinically significant ECG findings that are detected during the study will be reported as adverse events]; Hematology and chemistry laboratory values [clinically significant abnormal laboratory findings that are detected during the study will be reported as adverse events]; Vital signs [pulse, temperature, heart rate and blood pressure] and physical examination data changes noted as clinically significant abnormalities that arise during the study will be recorded as adverse events

  2. Change in mean seated systolic blood pressure (SBP) [12 weeks]

Secondary Outcome Measures

  1. Change in mean diastolic blood pressure (DBP) [12 Weeks]

  2. The percentage of patients achieving a seated blood pressure (BP) response <140/90 mmHg [Within 10 min after drug administration, for at least 4 weeks]

  3. The percentage of patients achieving a seated BP response <130/80 mmHg [Within 10 min after drug administration, for at least 4 weeks]

  4. The percentage of patients achieving either: - a plasma aldosterone concentration (PAC) < 15 ng/dL and a plasma renin activity (PRA) ≥ 0.5 ng/mL/h; or - an ARR < 15; or - unsuppressed renin activity PRA ≥ 1.0 ng/mL/h [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Have been diagnosed with PA.

  2. Are taking mineralocorticoid receptor antagonist (MRA) to control BP; or are newly diagnosed with PA and have not started MRA treatment.

  3. Are willing and able to cease dosing of MRA for up to 4 weeks in patients taking MRA.

  4. Are willing to be compliant with the contraception and reproduction restrictions of the study.

  5. Have increased SBP by ≥ 20 mmHg or have SBP ≥ 160 mmHg after dosing of MRA treatment is ceased for up to 4 weeks duration, or have SBP ≥ 150 mmHg for patients who are newly diagnosed with PA and have not taken an MRA in the past 12 weeks.

Exclusion Criteria:
  1. At Screening Visit, have a single occurrence of mean seated SBP > 180 mmHg or DBP > 110 mmHg if not taking an MRA; or have a mean seated SBP ≥ 160 mmHg or DBP ≥ 100 mmHg if currently taking an MRA.

  2. Have a body mass index > 45 kg/m2.

  3. Have had a previous surgical intervention for an adrenal adenoma or have a planned adrenal carcinoma, adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the course of the study.

  4. Have a documented estimated glomerular filtration rate < 45 mL/min/1.73 m2.

  5. Have a planned dialysis, kidney transplantation or any major surgical procedure during the course of the study.

  6. Have known documented New York Heart Association class III or IV chronic heart failure.

  7. Have had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before the Screening Visit.

  8. Have known current severe left ventricular outflow obstruction.

  9. Have had major cardiac surgery within 6 months before the Screening Visit.

  10. Have a history of, or currently experiencing, clinically significant arrhythmias.

  11. Have had a prior solid organ transplant or cell transplant.

  12. Are positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen.

  13. Have typical consumption of > 14 alcoholic drinks weekly.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CinCor Site 16 Los Angeles California United States 90048
2 CinCor Site 03 San Francisco California United States 94110
3 CinCor Site 10 Stanford California United States 94305
4 CinCor Site 12 Chicago Illinois United States 60611
5 CinCor Site 04 Baltimore Maryland United States 21287
6 CinCor Site 02 Ann Arbor Michigan United States 48109
7 CinCor Site 01 Rochester Minnesota United States 55905
8 CinCor Site 09 Columbus Ohio United States 43210
9 CinCor Site 17 Dallas Texas United States 75309

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:
NCT04605549
Other Study ID Numbers:
  • CIN-107-122
First Posted:
Oct 28, 2020
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by CinCor Pharma, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2022