Primary AldosteronismPhase 2NCT07646535
A Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Primary Aldosteronism
A Phase 2 study testing SAL0140 Tablets in people with Primary Aldosteronism, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled phase II study designed to explore the efficacy and safety of different doses of SAL0140 in primary aldosteronism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- SAL0140 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2026to 31 Dec 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years , regardless of gender.
- Diagnosed with primary aldosteronism (PA).
- Mean seated office systolic blood pressure (msSBP) ≥145 mmHg.
- Receiving stable background antihypertensive therapy.
- Serum potassium tested at local laboratory ≥3.0 mmol/L and <5.0 mmol/L.
- Morning serum cortisol >3 μg/dL.
- Voluntarily participate in the trial and provide written informed consent. Agree to comply with trial contraception and reproductive restrictions.
Who cannot join
- Mean seated office systolic blood pressure (msSBP) ≥180 mmHg and/or mean seated office diastolic blood pressure (msDBP) ≥110 mmHg.
- History or diagnosis of malignant hypertension, hypertensive emergency, hypertensive crisis or hypertensive encephalopathy.
- History or diagnostic evidence of other secondary hypertension.
- Prior surgical resection for adrenal adenoma.
- Medication compliance <80% or >120%.
- PA complicated with acute coronary syndrome, myocardial infarction, percutaneous coronary intervention or stroke.
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- Receiving treatment with potassium-binding agents.
- Any clinically significant abnormal laboratory findings that, in the Investigator's opinion, may interfere with the evaluation of efficacy and/or safety endpoints of the study.
- Subjects with severe hepatobiliary diseases.
- Positive test for human immunodeficiency virus antibody (HIV), hepatitis C antibody (HCV), treponema pallidum antibody (TP), or positive hepatitis B surface antigen (HBsAg).
- Type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
- Morbid obesity.
- Receiving blood transfusion for anemia.
- History of adrenal insufficiency.
- History of solid organ or bone marrow transplantation.
- Prior exposure to rituximab or cytotoxic chemotherapeutic agents.
- Recent use of strong CYP3A inhibitors or CYP3A inducers.
- Concomitant use of antihypertensive drugs, or other chemical drugs, biological products, traditional Chinese medicines or natural products deemed inappropriate by the Investigator.
- Active malignancy or past medical history of malignant tumor.
- Patients on hemodialysis or strict salt-restricted diet.
- Gastrointestinal disorders or prior gastrointestinal surgery that may affect drug absorption or excretion.
- Known or suspected hypersensitivity to aldosterone synthase inhibitors; known contraindication or hypersensitivity to any background concomitant medications.
- History of substance abuse or chronic alcohol abuse.
- Female subjects who are pregnant, breastfeeding, or with positive pregnancy test result.
- Recent blood donation or major blood loss (>400 mL), or clinically diagnosed hypovolemia.
- Participation in any interventional clinical trial with investigational product within 3 months prior to screening (or within 5 half-lives of the investigational product, whichever is longer); or enrollment in any medical device clinical trial with implanted/used study device.
- Night shift work within 3 days prior to study visit and within 3 days before ambulatory blood pressure monitoring.
- Presence of clinically significant, unstable or uncontrolled concomitant diseases as assessed by the Investigator at screening.
- Any other conditions judged by the Investigator to render the subject unsuitable for trial participation and likely to confound efficacy and/or safety assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Weiqing Wang, PhD, 18917762201, wqingw61@163.com
Jiguang Wang, PhD, 13764189476, jiguangw@163.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Primary Aldosteronism
This is a multicenter, randomized, double-blind, placebo-controlled phase II study designed to explore the efficacy and safety of different doses of SAL0140 in primary aldosteronism.
Read the detailed description
Participants diagnosed with primary aldosteronism were randomly assigned to the low-dose group, high-dose group or placebo group for a double-blind treatment period. Participants subsequently entered an open-label period to assess long-term efficacy and safety.
- Conditions
- Primary Aldosteronism
- Being tested
- SAL0140 Tablets, SAL0140 placebo
- Keywords
- Primary Aldosteronism, Aldosterone Synthase Inhibitor, Renin
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAL0140 TabletsDrug
Drug: SAL0140 Tablets
SAL0140 TabletsDrug
SAL0140 Tablets
SAL0140 placeboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Low-dose group | Experimental | Not described Receives: Drug: SAL0140 Tablets |
| High-dose group | Experimental | Not described Receives: Drug: SAL0140 Tablets |
| Placebo group | Placebo comparator | Not described Receives: Drug: SAL0140 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The baseline change in mean seated systolic blood pressure (msSBP)
Change from baseline in mean seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment
Measured: at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start12 Jun 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- More trials run by Shenzhen Salubris Pharmaceuticals Co., Ltd.The 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646535
- Sponsor's protocol ID
- SAL0140C201
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT07646535
- Acronym / sponsor ID
- SAL0140C201
- Conditions
- Primary Aldosteronism
- Keywords
- Primary Aldosteronism, Aldosterone Synthase Inhibitor, Renin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Jun 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.
This is a multicenter, randomized, double-blind, placebo-controlled phase II study designed to explore the efficacy and safety of different doses of SAL0140 in primary aldosteronism.
Detailed description
Participants diagnosed with primary aldosteronism were randomly assigned to the low-dose group, high-dose group or placebo group for a double-blind treatment period. Participants subsequently entered an open-label period to assess long-term efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose group | Experimental | Drug: SAL0140 Tablets |
| High-dose group | Experimental | Drug: SAL0140 Tablets |
| Placebo group | Placebo comparator | Drug: SAL0140 placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥18 years , regardless of gender.
- Diagnosed with primary aldosteronism (PA).
- Mean seated office systolic blood pressure (msSBP) ≥145 mmHg.
- Receiving stable background antihypertensive therapy.
- Serum potassium tested at local laboratory ≥3.0 mmol/L and <5.0 mmol/L.
Key exclusion criteria (29 listed)
- Mean seated office systolic blood pressure (msSBP) ≥180 mmHg and/or mean seated office diastolic blood pressure (msDBP) ≥110 mmHg.
- History or diagnosis of malignant hypertension, hypertensive emergency, hypertensive crisis or hypertensive encephalopathy.
- History or diagnostic evidence of other secondary hypertension.
- Prior surgical resection for adrenal adenoma.
- Medication compliance <80% or >120%.
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 |
|---|---|---|
| SAL0140 TabletsDrug: SAL0140 Tablets | Drug | Low-dose group |
| SAL0140 TabletsSAL0140 Tablets | Drug | High-dose group |
| SAL0140 placeboPlacebo | Drug | Placebo group |
Primary outcome
The baseline change in mean seated systolic blood pressure (msSBP)
Time frame: at week 12
Change from baseline in mean seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment
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 12 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAL0140 Tablets in people with Primary Aldosteronism, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. 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 7 inclusion and 29 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: opening soon, as of the sponsor's last update on 12 Jun 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.
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?
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 Weiqing Wang, PhD (18917762201, wqingw61@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The baseline change in mean seated systolic blood pressure (msSBP) (time frame: at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2026.