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Not yet recruitingNCT07917039Updated Nov 6, 2026

SYH2072 Tablets in Participants With Primary Aldosteronism

A Phase 2 interventional study of SYH2072 tablets and Placebo in Primary Aldosteronism, sponsored by InnovStone Therapeutics Limited. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by InnovStone Therapeutics Limited (part of CSPC Pharmaceutical Group Limited) · Phase 2, Interventional, and Treatment

Updated Nov 6, 2026Title changedNewly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
60
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 SYH2072 tablets in Chinese participants with primary aldosteronism (PA) .

Read the detailed description

Participants diagnosed with primary aldosteronism will be randomly assigned to the SYH2072 group or the placebo group for a double-blind treatment period. SYH2072 (or matching placebo) will be administered once daily, with the dose up-titrated during the treatment period based on clinical response and tolerability.

02

Conditions studied

  • Primary Aldosteronism

Browse trials for

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 60 is close to the median of 63 across 94 interventional studies indexed under Hyperaldosteronism.

Browse Hyperaldosteronism studies →

Lead sponsor

InnovStone Therapeutics Limited is the lead sponsor of 6 studies on the registry; 6 are open to participants now.

Browse InnovStone Therapeutics Limited studies →All CSPC Pharmaceutical Group Limited studies →

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 or older; male or female.
  2. Documented diagnosis of primary aldosteronism (PA) before screening.
  3. Receiving stable antihypertensive therapy.
  4. Willing to discontinue mineralocorticoid receptor antagonists (MRA) or potassium-sparing diuretics.
  5. Mean seated office systolic blood pressure (SBP) ≥140 mmHg and \<180 mmHg, and mean seated office diastolic blood pressure (DBP) \<110 mmHg before randomization.
  6. Medication compliance of background antihypertensive therapy and placebo within 80%-120% during the run-in period.
  7. Voluntary participation in the study, with signed form.

Exclusion criteria

Exclusion Criteria:

  1. Night shift workers.
  2. Known secondary causes of hypertension other than PA.
  3. Hypotension.
  4. Known or allergic constitution.
  5. History of adrenal surgery, renal denervation, or similar procedures.
  6. History of adrenal insufficiency.
  7. Poorly controlled blood glucose, or GLP-1 receptor agonist not maintained at a stable dose for at least 4 weeks.
  8. Poorly controlled thyroid disease.
  9. Severe cardiovascular or cerebrovascular events within 6 months before screening.
  10. Severe arrhythmia within 6 months before screening.
  11. Severe heart failure within 6 months before screening.
  12. Major surgery within 6 months before screening.
  13. Severe gastrointestinal disease or history of gastrointestinal surgery.
  14. laboratory abnormalities.
  15. History of within 5 years.
  16. History of drug abuse within 5 years.
  17. Female participants who are pregnant, breastfeeding, or with a positive pregnancy test.
  18. Use of strong inhibitors or strong CYP3A4 inducers within 4 weeks before screening.
  19. Participation in any drug or device clinical trial within 3 months before screening.
  20. Regular alcohol consumption within 90 days before screening.
  21. Any other reason that, in the opinion of the investigator, may prevent the participant from completing the study, or any condition for which the investigator considers enrollment inappropriate.
Terms in these criteria, in plain language(5)

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.

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.

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.

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.

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    SYH2072 group

    SYH2072 Tablets

    Drug: SYH2072 tablets · Drug: Placebo

  • Placebo comparator
    Placebo group

    Placebo

    Drug: Placebo

Interventions

  • DrugSYH2072 tablets

    SYH2072 tablets administered orally, once daily (QD)

  • DrugPlacebo

    Placebo administered orally, once daily (QD).

06

What researchers measure

Primary outcomes

  1. Change from baseline in seated Systolic Blood Pressure (SBP) at Week 8

    To evaluate the efficacy of SYH2072 tablets in improving blood pressure in trial participants with primary aldosteronism (PA) in China.

    Time frame: week 8

07

Study locations

1 site
08

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Feb 2028, 14 months later.

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

Registered
Oct 29, 2026
First posted
Nov 4, 2026
StartEst.
Nov 13, 2026
Primary completionEst.
Feb 1, 2028
CompletionEst.
Jun 4, 2028
Last update
Nov 6, 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.
Title
A Phase Ⅱ Clinical Trial of SYH2072 Tablets in Participants With Primary Aldosteronism
Nov 6, 2026
Registered
First appeared on the registry
Nov 4, 2026
Show all 2 updates
  1. Nov 6, 2026
    Title A Phase Ⅱ Clinical Trial of SYH2072 Tablets in Participants With Primary Aldosteronism
  2. Nov 4, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07917039
Lead sponsor
InnovStone Therapeutics Limited
Responsible party
Sponsor
First posted
Nov 4, 2026
Start date
Nov 13, 2026 (estimated)
Primary completion
Feb 1, 2028 (estimated)
Completion
Jun 4, 2028 (estimated)
Last update
Nov 6, 2026

Study contacts

Clinical Trials Information Group NA officer
Contact
ctr-contact@cspc.cn
86-311-69085587
Yuguo Chen, Medical Doctor
study chair · Qilu Hospital of Shandong University

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 Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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