Primary AldosteronismPhase 2NCT04605549

A Study of CIN-107 in Adults With Primary Aldosteronism

A Phase 2 study testing CIN-107 2 mg dosing, CIN-107 4 mg dosing and CIN-107 8 mg dosing in people with Primary Aldosteronism and Hyperaldosteronism, run by AstraZeneca at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Primary Aldosteronism, Hyperaldosteronism
What is being tested?: CIN-107 2 mg dosing, CIN-107 4 mg dosing and CIN-107 8 mg dosing
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 10 sitesUnited States
Study dates: 8 Mar 2021to 28 Oct 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 13Show fewer

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.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Research Site
Ann Arbor, Michigan, 48109
Research Site
Baltimore, Maryland, 21287
Research Site
Chicago, Illinois, 60611
Research Site
Cincinnati, Ohio, 45245
Research Site
Columbus, Ohio, 43210
Research Site
Dallas, Texas, 75390-9047
Research Site
Greenbrae, California, 94904
Research Site
Rochester, Minnesota, 55905
Research Site
San Francisco, California, 94110
Research Site
West Hollywood, California, 90048

Other trials in United States

About this study

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

Read the detailed description

For patients in Part 1 only :

The treatment duration for patients who complete all 3 dose levels, and who opt not to continue in the extension part of the study, is 12 weeks. For patients who do not complete up-titration, the treatment duration will include at least 4 weeks of dosing with the final dose level. If down-titration of CIN-107 dose is determined at Visit 6 (Week 9), the total treatment duration may be extended to 13 weeks to allow sufficient time for CIN-107 treatment effect at the final dose to be assessed. If the final dose of CIN-107 is reached before week 8 (Visit 5) and no up-titration occurs at Visit 5, the patients will be encouraged to continue CIN-107 treatment till Visit 7 for a total of 12 weeks of treatment. The patients who opt not to continue to Part 2 will not receive any study drug and will return for their safety follow up visit (Visit 8) in 2 weeks.

For patients who opt to continue in the extension part (Part 2) of the study:

Patients will continue to receive their dose of baxdrostat and be instructed to measure BP at least once every week prior to dosing with CIN-107 in the morning, during the extension phase. Safety surveillance will be conducted if clinically indicated. Repeat and unscheduled testing for serum potassium may be measured at the investigator's clinical site or at local laboratory for a faster turn-around time to allow clinical assessment. These patients entering part 2 will skip Visit 8 and their next visit will be Visit 9.

Conditions: Primary Aldosteronism, Hyperaldosteronism
Being tested: CIN-107 2 mg dosing, CIN-107 4 mg dosing, CIN-107 8 mg dosing
Keywords: Primary Aldosteronism
Medical subject headings: Hyperaldosteronism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CIN-107 2 mg dosingDrug
One tablet of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 2 mg.
CIN-107 4 mg dosingDrug
Two tablets of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 4 mg.
CIN-107 8 mg dosingDrug
Four tablets of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 8 mg.

Study groups in NCT04605549
Study group	Role	What they receive
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. Receives: Drug: CIN-107 2 mg dosing; Drug: CIN-107 4 mg dosing; Drug: CIN-107 8 mg dosing

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 12 weeks

Secondary outcomes (4)

Change From Baseline in Mean Diastolic Blood Pressure (DBP) in Patients With Primary Aldosteronism
The mean DBP was defined as the average of 3 measurements obtained at the clinical site visit. The change from baseline in mean DBP after 12 weeks of treatment with CIN-107 (Part 1) is calculated.
Measured: 12 weeks
The Percentage of Patients Achieving a Seated BP Response of <140/90 mmHg
The percentage of patients achieving a mean seated SBP <140 mmHg and a mean DBP of <90 mmHg after 12 weeks of treatment with CIN-107 (Part 1) is calculated.
Measured: 12 weeks
The Percentage of Patients Achieving a Seated BP Response of <130/80 mmHg
The percentage of patients achieving a mean seated SBP <130 mmHg and a mean DBP of <80 mmHg after 12 weeks of treatment with CIN-107 (Part 1) is calculated.
Measured: 12 weeks
The Percentage of Patients Achieving the Pharmacodynamic Marker Response
Pharmacodynamic marker response is defined as 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
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Mar 202128 Oct 2024

First posted28 Oct 2020
Study start8 Mar 2021
Primary completion28 Oct 2024
Study completion28 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Primary AldosteronismStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04605549
Sponsor's protocol ID: CIN-107-122
Other IDs: D6970C00001
Status last verified: Feb 2026
First submitted: 22 Oct 2020
Last updated: 3 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Publications

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.
PubMed 37490693

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
SYH2072 Tablets in Participants With Primary Aldosteronism
Primary Aldosteronism
Recruiting
Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism (TARGET-PA)
Hyperaldosteronism; Primary, Primary Aldosteronism Due to Aldosterone Producing Adenoma
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
Active, not recruiting
Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA
Primary Aldosteronism

All Primary Aldosteronism trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04605549
Acronym / sponsor ID: CIN-107-122
Conditions: Primary Aldosteronism, Hyperaldosteronism
Keywords: Primary Aldosteronism
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 8 Mar 2021 (actual)
Primary completion: 28 Oct 2024 (actual)
Study completion: 28 Oct 2024 (actual)
First posted: 28 Oct 2020 (actual)
Results: Posted 3 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

For patients in Part 1 only :

For patients who opt to continue in the extension part (Part 2) of the study:

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CIN-107 for dosing at 2, 4, or 8 mg (QD)	Experimental	Drug: CIN-107 2 mg dosing, Drug: CIN-107 4 mg dosing, Drug: CIN-107 8 mg dosingPatients 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.

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CIN-107 2 mg dosingOne tablet of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 2 mg.	Drug	CIN-107 for dosing at 2, 4, or 8 mg (QD)
CIN-107 4 mg dosingTwo tablets of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 4 mg.	Drug	CIN-107 for dosing at 2, 4, or 8 mg (QD)
CIN-107 8 mg dosingFour tablets of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 8 mg.	Drug	CIN-107 for dosing at 2, 4, or 8 mg (QD)

Primary outcome

Number of Treatment Emergent Adverse Events
Time frame: 74 weeks
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.
Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) in Patients With Primary Aldosteronism
Time frame: 12 weeks
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.

4 secondary outcomes

Change From Baseline in Mean Diastolic Blood Pressure (DBP) in Patients With Primary Aldosteronism
Time frame: 12 weeks
The Percentage of Patients Achieving a Seated BP Response of <140/90 mmHg
Time frame: 12 weeks
The Percentage of Patients Achieving a Seated BP Response of <130/80 mmHg
Time frame: 12 weeks
The Percentage of Patients Achieving the Pharmacodynamic Marker Response
Time frame: 12 weeks

Results and safety

Results posted to the registry on 3 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CIN-107	15	15

Primary outcome: Number of Treatment Emergent Adverse Events

Time frame: 74 weeks. Number. Unit: Number of events

Measure	CIN-107 n = 15
Part 1 before titration (0-Week 4)	27
Part 1 after titration (Week 4-Week 12)	34
Part 2 (Week 12-Week 74)	101

Population analysed: The Safety Population is defined as all enrolled patients who receive at least one dose of study drug. Due to the small sample size of the study, arms/groups are combined for analysis.

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

Time frame: 12 weeks. Mean (Standard Deviation). Unit: mmHg

Measure	CIN-107 n = 15
Value	-24.9 (11.6)

Population analysed: ITT Population is defined as all participants enrolled in the study. Due to the small sample size of the study, arms/groups are combined for analysis.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CIN-107 2 mg Part 1 - Before Titration	0 of 15 (0%)	11 of 15 (73.3%)	0 of 15
CIN-107 2 mg Part 1 - After Titration	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
CIN-107 4 mg Part 1 - After Titration	0 of 13 (0%)	8 of 13 (61.5%)	0 of 13
CIN-107 8 mg Part 1 - After Titration	0 of 8 (0%)	2 of 8 (25%)	0 of 8
CIN-107 2 mg Part 2	0 of 4 (0%)	4 of 4 (100%)	0 of 4
CIN-107 4 mg Part 2	0 of 7 (0%)	6 of 7 (85.7%)	0 of 7
CIN-107 8 mg Part 2	1 of 7 (14.3%)	7 of 7 (100%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37490693Townsend 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.
Redacted CSR SynopsisLink provided by the sponsor.
Redacted CSPLink provided by the sponsor.
Redacted SAPLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Related trials for Primary Aldosteronism

Not yet recruitingPhase 2
SYH2072 Tablets in Participants With Primary Aldosteronism
Primary Aldosteronism
Recruiting
Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism (TARGET-PA)
Hyperaldosteronism; Primary, Primary Aldosteronism Due to Aldosterone Producing Adenoma
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
Active, not recruiting
Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA
Primary Aldosteronism

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CIN-107 2 mg dosing, CIN-107 4 mg dosing and CIN-107 8 mg dosing in people with Primary Aldosteronism and Hyperaldosteronism, run by AstraZeneca at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Treatment Emergent Adverse Events (time frame: 74 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04605549, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.