Primary AldosteronismNCT07884955
Comparing Inclisiran Versus Statin for Primary Aldosteronism
A study testing inclisiran, Lipophilic statins (such as Simvastatin, Atorvastatin, Fluvastatin, Lovastatin,Pitavastatin) and Spironolactone (drug) in people with Primary Aldosteronism, run by Third Military Medical University at 1 site in China.
Trial summary
Primary aldosteronism represents one of the leading causes of resistant hypertension. Circulating cholesterol is established as the exclusive substrate for adrenal aldosterone synthesis, and statins, which suppress cholesterol production, are currently widely applied in clinical settings. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- inclisiran, Lipophilic statins (such as Simvastatin, Atorvastatin, Fluvastatin, Lovastatin,Pitavastatin) and Spironolactone (drug)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hypertension aged18-70years.
- Meeting the diagnostic criteria for primary aldosteronism (PA) according to the *Expert Consensus on the Diagnosis and Treatment of Primary Aldosteronism (2025 Edition)
- Patients either untreated or on antihypertensive therapy; after a 1-2week washout period, blood pressure is <160/100mmHg.
- Serum potassium at the end of the run-in period: 3mmol/L ≤ serum potassium <5mmol/L.
- Voluntary participation in the trial and provision of written informed consent.
Who cannot join
- Office blood pressure >180/110mmHg.
- Severe hepatic insufficiency or severe renal insufficiency.
- Acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, or cerebrovascular accident within the previous 6 months; heart failure of NYHA class II-IV.
- Serum potassium <2.5mmol/L or >5.5mmol/L.
- Pregnancy or planned pregnancy within 1year.
- Neurological or psychiatric disorders.
Show all 9Show fewer
- Concurrent malignant neoplasm.
- Low-density-lipoprotein-cholesterol(LDL-C) <2.6mmol/L.
- Any other conditions that, in the investigator's opinion, may interfere with efficacy and/or safety assessment of the study (including but not limited to poor subject compliance or inability to attend scheduled follow-up due to long-distance residence).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zhiming Zhu contact
China1 site, 1 recruiting
- Recruiting
Daping Hospital,Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Zhiming Zhu, +8613608313322, hbpcms@sina.com
About this study
Official title: A Randomized Controlled Study Comparing Inclisiran Plus Spironolactone Versus Statin Plus Spironolactone for Primary Aldosteronism
Primary aldosteronism represents one of the leading causes of resistant hypertension. Circulating cholesterol is established as the exclusive substrate for adrenal aldosterone synthesis, and statins, which suppress cholesterol production, are currently widely applied in clinical settings. Emerging clinical evidence has demonstrated that in patients with essential hypertension, the plasma aldosterone level decreased by 43% (from 13.9 ng/dL to 7.9 ng/dL) after treatment with PCSK9 inhibitors. However, the effect of PCSK9 inhibitors with superior lipid-lowering efficacy combined with amlodipine besylate on aldosterone levels remains elusive. The present clinical trial adopted inclisiran, a PCSK9 inhibitor with well-documented clinical safety and robust lipid-lowering effects, in combination with amlodipine besylate. Through randomized grouping intervention and follow-up, this study aimed to compare the differential effects of two therapeutic regimens-inclisiran-based therapy and statin-based therapy-on plasma aldosterone levels, as well as improvements in a spectrum of clinical parameters including blood pressure , serum potassium and so on in patients with primary aldosteronism. The outcomes of this trial are expected to provide novel and more effective pharmacological strategies for the management of primary aldosteronism.
- Conditions
- Primary Aldosteronism
- Being tested
- inclisiran, Lipophilic statins (such as Simvastatin, Atorvastatin, Fluvastatin, Lovastatin,Pitavastatin), Spironolactone (drug), Amlodipine besylate
- Keywords
- primary aldosteronism, PCSK9, Statins, Inclisiran
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inclisiranDrug
Subcutaneous inclisiran
Lipophilic statins (such as Simvastatin, Atorvastatin, Fluvastatin, Lovastatin,Pitavastatin)Drug
oral Lipophilic statins (such as Simvastatin, Atorvastatin, Fluvastatin, Lovastatin,Pitavastatin)
Spironolactone (drug)Drug
oral Spironolactone
Amlodipine besylateDrug
oral Amlodipine besylate
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous inclisiran plus oral amlodipine besylate and spironolactone | Experimental | Participants receive inclisiran subcutaneously plus oral amlodipine besylate and spironolactone Receives: Drug: inclisiran; Drug: Spironolactone (drug); Drug: Amlodipine besylate |
| Statin plus amlodipine besylate and spironolactone | Placebo comparator | Participants receive statin plus oral amlodipine besylate and spironolactone Receives: Drug: Lipophilic statins (such as Simvastatin, Atorvastatin, Fluvastatin, Lovastatin,Pitavastatin); Drug: Spironolactone (drug); Drug: Amlodipine besylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in plasma aldosterone level
Measured: 24 weeks after randomization
Secondary outcomes (6)
Change from baseline in systolic and diastolic blood pressure
Measured: 24 weeks after randomization
Change from baseline in plasma renin concentration
Measured: 24 weeks after randomization
Change from baseline in 24-hour urinary aldosterone
Measured: 24 weeks after randomization
Change from baseline in serum potassium level
Measured: 24 weeks after randomization
Change from baseline in plasma lipid
Measured: 24 weeks after randomization
Change from baseline in glucose
Measured: 24 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiming Zhu, Army Medical Center of PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884955
- Sponsor's protocol ID
- ISPA
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu H, He H, Han T, Tian X, Zhu Z. Targeting cholesterol-dependent adrenal steroidogenesis for management of primary aldosteronism. Trends Endocrinol Metab. 2025 Sep;36(9):789-801. doi: 10.1016/j.tem.2024.12.001. Epub 2025 Jan 6.
PubMed 39765399Izkhakov E, Shacham Y, Serebro M, Yaish I, Marcus Y, Shefer G, Tordjman K, Greenman Y, Stern N, Ziv-Baran T. The Effect of the PCSK9 Inhibitor Evolocumab on Aldosterone Secretion among High Cardiovascular Risk Patients: A Pilot Study. J Clin Med. 2021 Jun 5;10(11):2504. doi: 10.3390/jcm10112504.
PubMed 34198795Navarese EP, Kolodziejczak M, Schulze V, Gurbel PA, Tantry U, Lin Y, Brockmeyer M, Kandzari DE, Kubica JM, D'Agostino RB Sr, Kubica J, Volpe M, Agewall S, Kereiakes DJ, Kelm M. Effects of Proprotein Convertase Subtilisin/Kexin Type 9 Antibodies in Adults With Hypercholesterolemia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Jul 7;163(1):40-51. doi: 10.7326/M14-2957.
PubMed 25915661Baudrand R, Pojoga LH, Vaidya A, Garza AE, Vohringer PA, Jeunemaitre X, Hopkins PN, Yao TM, Williams J, Adler GK, Williams GH. Statin Use and Adrenal Aldosterone Production in Hypertensive and Diabetic Subjects. Circulation. 2015 Nov 10;132(19):1825-33. doi: 10.1161/CIRCULATIONAHA.115.016759. Epub 2015 Oct 2.
PubMed 26432671Capponi AM. Regulation of cholesterol supply for mineralocorticoid biosynthesis. Trends Endocrinol Metab. 2002 Apr;13(3):118-21. doi: 10.1016/s1043-2760(01)00538-0.
PubMed 11893525
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Comparing Inclisiran Plus Spironolactone Versus Statin Plus Spironolactone for Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT07884955
- Acronym / sponsor ID
- ISPA
- Conditions
- Primary Aldosteronism
- Keywords
- primary aldosteronism, PCSK9, Statins, Inclisiran
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary aldosteronism represents one of the leading causes of resistant hypertension. Circulating cholesterol is established as the exclusive substrate for adrenal aldosterone synthesis, and statins, which suppress cholesterol production, are currently widely applied in clinical settings. Emerging clinical evidence has demonstrated that in patients with essential hypertension, the plasma aldosterone level decreased by 43% (from 13.9 ng/dL to 7.9 ng/dL) after treatment with PCSK9 inhibitors. However, the effect of PCSK9 inhibitors with superior lipid-lowering efficacy combined with amlodipine besylate on aldosterone levels remains elusive. The present clinical trial adopted inclisiran, a PCSK9 inhibitor with well-documented clinical safety and robust lipid-lowering effects, in combination with amlodipine besylate. Through randomized grouping intervention and follow-up, this study aimed to compare the differential effects of two therapeutic regimens-inclisiran-based therapy and statin-based therapy-on plasma aldosterone levels, as well as improvements in a spectrum of clinical parameters including blood pressure , serum potassium and so on in patients with primary aldosteronism. The outcomes of this trial are expected to provide novel and more effective pharmacological strategies for the management of primary aldosteronism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous inclisiran plus oral amlodipine besylate and spironolactone | Experimental | Drug: inclisiran, Drug: Spironolactone (drug), Drug: Amlodipine besylateParticipants receive inclisiran subcutaneously plus oral amlodipine besylate and spironolactone |
| Statin plus amlodipine besylate and spironolactone | Placebo comparator | Drug: Lipophilic statins (such as Simvastatin, Atorvastatin, Fluvastatin, Lovastatin,Pitavastatin), Drug: Spironolactone (drug), Drug: Amlodipine besylateParticipants receive statin plus oral amlodipine besylate and spironolactone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with hypertension aged18-70years.
- Meeting the diagnostic criteria for primary aldosteronism (PA) according to the *Expert Consensus on the Diagnosis and Treatment of Primary Aldosteronism (2025 Edition)
- Patients either untreated or on antihypertensive therapy; after a 1-2week washout period, blood pressure is <160/100mmHg.
- Serum potassium at the end of the run-in period: 3mmol/L ≤ serum potassium <5mmol/L.
- Voluntary participation in the trial and provision of written informed consent.
Key exclusion criteria (9 listed)
- Office blood pressure >180/110mmHg.
- Severe hepatic insufficiency or severe renal insufficiency.
- Acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, or cerebrovascular accident within the previous 6 months; heart failure of NYHA class II-IV.
- Serum potassium <2.5mmol/L or >5.5mmol/L.
- Pregnancy or planned pregnancy within 1year.
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 |
|---|---|---|
| inclisiranSubcutaneous inclisiran | Drug | Subcutaneous inclisiran plus oral amlodipine besylate and spironolactone |
| Lipophilic statins (such as Simvastatin, Atorvastatin, Fluvastatin, Lovastatin,Pitavastatin)oral Lipophilic statins (such as Simvastatin, Atorvastatin, Fluvastatin, Lovastatin,Pitavastatin) | Drug | Statin plus amlodipine besylate and spironolactone |
| Spironolactone (drug)oral Spironolactone | Drug | Statin plus amlodipine besylate and spironolactone, Subcutaneous inclisiran plus oral amlodipine besylate and spironolactone |
| Amlodipine besylateoral Amlodipine besylate | Drug | Statin plus amlodipine besylate and spironolactone, Subcutaneous inclisiran plus oral amlodipine besylate and spironolactone |
Primary outcome
Change from baseline in plasma aldosterone level
Time frame: 24 weeks after randomization
6 secondary outcomes
Change from baseline in systolic and diastolic blood pressure
Time frame: 24 weeks after randomization
Change from baseline in plasma renin concentration
Time frame: 24 weeks after randomization
Change from baseline in 24-hour urinary aldosterone
Time frame: 24 weeks after randomization
Change from baseline in serum potassium level
Time frame: 24 weeks after randomization
Change from baseline in plasma lipid
Time frame: 24 weeks after randomization
Change from baseline in glucose
Time frame: 24 weeks after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 39765399Wu H, He H, Han T, Tian X, Zhu Z. Targeting cholesterol-dependent adrenal steroidogenesis for management of primary aldosteronism. Trends Endocrinol Metab. 2025 Sep;36(9):789-801. doi: 10.1016/j.tem.2024.12.001. Epub 2025 Jan 6.
- Background: PubMed 34198795Izkhakov E, Shacham Y, Serebro M, Yaish I, Marcus Y, Shefer G, Tordjman K, Greenman Y, Stern N, Ziv-Baran T. The Effect of the PCSK9 Inhibitor Evolocumab on Aldosterone Secretion among High Cardiovascular Risk Patients: A Pilot Study. J Clin Med. 2021 Jun 5;10(11):2504. doi: 10.3390/jcm10112504.
- Background: PubMed 25915661Navarese EP, Kolodziejczak M, Schulze V, Gurbel PA, Tantry U, Lin Y, Brockmeyer M, Kandzari DE, Kubica JM, D'Agostino RB Sr, Kubica J, Volpe M, Agewall S, Kereiakes DJ, Kelm M. Effects of Proprotein Convertase Subtilisin/Kexin Type 9 Antibodies in Adults With Hypercholesterolemia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Jul 7;163(1):40-51. doi: 10.7326/M14-2957.
- Background: PubMed 26432671Baudrand R, Pojoga LH, Vaidya A, Garza AE, Vohringer PA, Jeunemaitre X, Hopkins PN, Yao TM, Williams J, Adler GK, Williams GH. Statin Use and Adrenal Aldosterone Production in Hypertensive and Diabetic Subjects. Circulation. 2015 Nov 10;132(19):1825-33. doi: 10.1161/CIRCULATIONAHA.115.016759. Epub 2015 Oct 2.
- Background: PubMed 11893525Capponi AM. Regulation of cholesterol supply for mineralocorticoid biosynthesis. Trends Endocrinol Metab. 2002 Apr;13(3):118-21. doi: 10.1016/s1043-2760(01)00538-0.
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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.
Zhiming Zhu contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inclisiran, Lipophilic statins (such as Simvastatin, Atorvastatin, Fluvastatin, Lovastatin,Pitavastatin) and Spironolactone (drug) in people with Primary Aldosteronism, run by Third Military Medical University at 1 site in China.
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 9 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liyuan Yuan (+8617374960635, 706539967@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in plasma aldosterone level (time frame: 24 weeks after randomization). 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 NCT07884955, which also lists 5 linked publications.
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 21 Oct 2026.