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Not yet recruitingNCT07646535Updated Jun 12, 2026

A Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Primary Aldosteronism

A Phase 2 interventional study of SAL0140 Tablets and SAL0140 Tablets in Primary Aldosteronism, sponsored by Shenzhen Salubris Pharmaceuticals Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Shenzhen Salubris Pharmaceuticals Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Primary Aldosteronism

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Keywords

  • Primary Aldosteronism
  • Aldosterone Synthase Inhibitor
  • Renin
03

In context

Hyperaldosteronism

201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.

This study's planned enrollment of 50 is below the median of 63 across 94 interventional studies indexed under Hyperaldosteronism.

Browse Hyperaldosteronism studies →

Lead sponsor

Shenzhen Salubris Pharmaceuticals Co., Ltd. is the lead sponsor of 42 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Aged ≥18 years , regardless of gender.
  2. Diagnosed with primary aldosteronism (PA).
  3. Mean seated office systolic blood pressure (msSBP) ≥145 mmHg.
  4. Receiving stable background antihypertensive therapy.
  5. Serum potassium tested at local laboratory ≥3.0 mmol/L and \<5.0 mmol/L.
  6. Morning serum cortisol >3 μg/dL.
  7. Voluntarily participate in the trial and provide written . Agree to comply with trial and reproductive restrictions.

Exclusion criteria

Exclusion Criteria:

  1. Mean seated office systolic blood pressure (msSBP) ≥180 mmHg and/or mean seated office diastolic blood pressure (msDBP) ≥110 mmHg.
  2. History or diagnosis of malignant hypertension, hypertensive emergency, hypertensive crisis or hypertensive encephalopathy.
  3. History or diagnostic evidence of other secondary hypertension.
  4. Prior surgical resection for adrenal adenoma.
  5. Medication compliance \<80% or >120%.
  6. PA complicated with acute coronary syndrome, myocardial infarction, percutaneous coronary intervention or stroke.
  7. Receiving treatment with potassium-binding agents.
  8. Any abnormal laboratory findings that, in the Investigator's opinion, may interfere with the evaluation of efficacy and/or safety endpoints of the study.
  9. Subjects with severe hepatobiliary diseases.
  10. Positive test for antibody (HIV), antibody (HCV), treponema pallidum antibody (TP), or positive surface antigen (HBsAg).
  11. Type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
  12. Morbid obesity.
  13. Receiving blood transfusion for anemia.
  14. History of adrenal insufficiency.
  15. History of solid organ or bone marrow transplantation.
  16. Prior exposure to rituximab or cytotoxic chemotherapeutic agents.
  17. Recent use of strong inhibitors or CYP3A inducers.
  18. Concomitant use of antihypertensive drugs, or other chemical drugs, biological products, traditional Chinese medicines or natural products deemed inappropriate by the Investigator.
  19. Active or past medical history of malignant tumor.
  20. Patients on hemodialysis or strict salt-restricted diet.
  21. Gastrointestinal disorders or prior gastrointestinal surgery that may affect drug absorption or excretion.
  22. Known or suspected to aldosterone synthase inhibitors; known or hypersensitivity to any background concomitant medications.
  23. History of substance abuse or chronic alcohol abuse.
  24. Female subjects who are pregnant, breastfeeding, or with positive pregnancy test result.
  25. Recent blood donation or major blood loss (>400 mL), or clinically diagnosed hypovolemia.
  26. Participation in any interventional clinical trial with 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.
  27. Night shift work within 3 days prior to study visit and within 3 days before ambulatory blood pressure monitoring.
  28. Presence of clinically significant, unstable or uncontrolled concomitant diseases as assessed by the Investigator at screening.
  29. Any other conditions judged by the Investigator to render the subject unsuitable for trial participation and likely to confound efficacy and/or safety assessment.
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Low-dose group

    Drug: SAL0140 Tablets

  • Experimental
    High-dose group

    Drug: SAL0140 Tablets

  • Placebo comparator
    Placebo group

    Drug: SAL0140 placebo

Interventions

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: at week 12

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2026; primary completion for Apr 2027, 9 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 8, 2026
First posted
Jun 12, 2026
StartEst.
Jun 12, 2026
Primary completionEst.
Apr 1, 2027
CompletionEst.
Dec 31, 2027
Last update
Jun 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07646535
Responsible party
Sponsor
First posted
Jun 12, 2026
Start date
Jun 12, 2026 (estimated)
Primary completion
Apr 1, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jun 12, 2026

Study contacts

Weiqing Wang, PhD
Contact
wqingw61@163.com
18917762201
Jiguang Wang, PhD
Contact
jiguangw@163.com
13764189476

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: SAL0140

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