A Study of CIN-107 in Adults With Primary Aldosteronism

NCT04605549 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: CIN-107-122D6970C00001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 10

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 (Part 1), and then for eligible, consenting patients follow patients in Part 2 for up to 74 weeks for evidence of long-term safety and tolerability.

Conditions

Primary Aldosteronism; Hyperaldosteronism

Keywords

Primary Aldosteronism

Outcome Measures

Primary Outcomes (2)

• Number of Treatment Emergent Adverse Events

  An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Adverse events were collected from the beginning of the study until Week 74. Treatment emergent AEs are defined as AEs that newly occur or worsen in severity during the treatment period.

  74 weeks

• Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) in Patients With Primary Aldosteronism

  The mean seated SBP was defined as the average of 3 measurements obtained at the clinical site visit. The change from baseline in mean seated SBP after 12 weeks of treatment with CIN-107 (Part 1) is calculated.

  12 weeks

Secondary Outcomes (4)

• Change From Baseline in Mean Diastolic Blood Pressure (DBP) in Patients With Primary Aldosteronism

  12 weeks

• The Percentage of Patients Achieving a Seated BP Response of <140/90 mmHg

  12 weeks

• The Percentage of Patients Achieving a Seated BP Response of <130/80 mmHg

  12 weeks

• The Percentage of Patients Achieving the Pharmacodynamic Marker Response

  12 weeks

Study Arms (1)

CIN-107 for dosing at 2, 4, or 8 mg (QD)

EXPERIMENTAL

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; Drug: CIN-107 4 mg dosing; Drug: CIN-107 8 mg dosing

Interventions

CIN-107 2 mg dosing DRUG

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

CIN-107 for dosing at 2, 4, or 8 mg (QD)

CIN-107 4 mg dosing DRUG

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

CIN-107 for dosing at 2, 4, or 8 mg (QD)

CIN-107 8 mg dosing DRUG

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

CIN-107 for dosing at 2, 4, or 8 mg (QD)

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have been diagnosed with PA.
• Are taking mineralocorticoid receptor antagonist (MRA) to control BP; or are newly diagnosed with PA and have not started MRA treatment.
• Are willing and able to cease dosing of MRA for up to 4 weeks in patients taking MRA.
• Are willing to be compliant with the contraception and reproduction restrictions of the study.
• 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.

You may not qualify if:

• 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.
• Have a body mass index \> 45 kg/m2.
• 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.
• Have a documented estimated glomerular filtration rate \< 45 mL/min/1.73 m2.
• Have a planned dialysis, kidney transplantation or any major surgical procedure during the course of the study.
• Have known documented New York Heart Association class III or IV chronic heart failure.
• Have had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before the Screening Visit.
• Have known current severe left ventricular outflow obstruction.
• Have had major cardiac surgery within 6 months before the Screening Visit.
• Have a history of, or currently experiencing, clinically significant arrhythmias.
• Have had a prior solid organ transplant or cell transplant.
• Are positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen.
• Have typical consumption of \> 14 alcoholic drinks weekly.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (10)

Research Site

Greenbrae, California, 94904, United States

Location

Research Site

San Francisco, California, 94110, United States

Location

Research Site

West Hollywood, California, 90048, United States

Location

Research Site

Chicago, Illinois, 60611, United States

Location

Research Site

Baltimore, Maryland, 21287, United States

Location

Research Site

Ann Arbor, Michigan, 48109, United States

Location

Research Site

Rochester, Minnesota, 55905, United States

Location

Research Site

Cincinnati, Ohio, 45245, United States

Location

Research Site

Columbus, Ohio, 43210, United States

Location

Research Site

Dallas, Texas, 75390-9047, United States

Location

Related Publications (1)

• Townsend RR. Blocking Aldosterone Synthesis: Whose BrigHTN Idea Was That? Clin J Am Soc Nephrol. 2023 Dec 1;18(12):1631-1633. doi: 10.2215/CJN.0000000000000265. Epub 2023 Jul 24. No abstract available.

  PMID: 37490693 DERIVED

Related Links

• Redacted CSR Synopsis
• Redacted CSP
• Redacted SAP

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 28, 2020
• Study Start: March 8, 2021
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: March 3, 2026
• Results First Posted: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (10)