Primary AldosteronismPhase 2NCT07917039
SYH2072 Tablets in Participants With Primary Aldosteronism
A Phase 2 study testing SYH2072 tablets in people with Primary Aldosteronism, run by InnovStone Therapeutics Limited 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 SYH2072 tablets in Chinese participants with primary aldosteronism (PA) . 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?
- SYH2072 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2026to 4 Jun 2028
- 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 or older; male or female.
- Documented diagnosis of primary aldosteronism (PA) before screening.
- Receiving stable antihypertensive therapy.
- Willing to discontinue mineralocorticoid receptor antagonists (MRA) or potassium-sparing diuretics.
- Mean seated office systolic blood pressure (SBP) ≥140 mmHg and <180 mmHg, and mean seated office diastolic blood pressure (DBP) <110 mmHg before randomization.
- Medication compliance of background antihypertensive therapy and placebo within 80%-120% during the run-in period.
- Voluntary participation in the study, with signed informed consent form.
Who cannot join
- Night shift workers.
- Known secondary causes of hypertension other than PA.
- Hypotension.
- Known hypersensitivity or allergic constitution.
- History of adrenal surgery, renal denervation, or similar procedures.
- History of adrenal insufficiency.
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- Poorly controlled blood glucose, or GLP-1 receptor agonist not maintained at a stable dose for at least 4 weeks.
- Poorly controlled thyroid disease.
- Severe cardiovascular or cerebrovascular events within 6 months before screening.
- Severe arrhythmia within 6 months before screening.
- Severe heart failure within 6 months before screening.
- Major surgery within 6 months before screening.
- Severe gastrointestinal disease or history of gastrointestinal surgery.
- Clinically significant laboratory abnormalities.
- History of malignancy within 5 years.
- History of drug abuse within 5 years.
- Female participants who are pregnant, breastfeeding, or with a positive pregnancy test.
- Use of strong CYP3A4 inhibitors or strong CYP3A4 inducers within 4 weeks before screening.
- Participation in any drug or device clinical trial within 3 months before screening.
- Regular alcohol consumption within 90 days before screening.
- 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.
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
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
86-531-82169603, qlyygcp_ec@qiluhospital.cn
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of SYH2072 Tablets in Chinese Participants With Primary Aldosteronism
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.
- Conditions
- Primary Aldosteronism
- Being tested
- SYH2072 tablets, Placebo
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYH2072 tabletsDrug
SYH2072 tablets administered orally, once daily (QD)
PlaceboDrug
Placebo administered orally, once daily (QD).
| Study group | Role | What they receive |
|---|---|---|
| SYH2072 group | Experimental | SYH2072 Tablets Receives: Drug: SYH2072 tablets; Drug: Placebo |
| Placebo group | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start13 Nov 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion4 Jun 2028 (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.
- 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
- Model description
- This is a parallel-group design. Participants diagnosed with Primary aldosteronism will be randomly assigned to the SYH2072 treatment or placebo group.All participants will undergo regular dose increases in accordance with drug tolerance criteria, or may have their dose reduced at any time based on safety criteria.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InnovStone Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuguo Chen, Medical Doctor, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917039
- Sponsor's protocol ID
- SYH2072-004
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 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 to Evaluate the Efficacy and Safety of SYH2072 Tablets in Chinese Participants With Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT07917039
- Acronym / sponsor ID
- SYH2072-004
- Conditions
- Primary Aldosteronism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- InnovStone Therapeutics LimitedIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 4 Jun 2028 (estimated)
- First posted
- 4 Nov 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 SYH2072 tablets in Chinese participants with primary aldosteronism (PA) .
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a parallel-group design. Participants diagnosed with Primary aldosteronism will be randomly assigned to the SYH2072 treatment or placebo group.All participants will undergo regular dose increases in accordance with drug tolerance criteria, or may have their dose reduced at any time based on safety criteria.
| Arm | Type | Receives |
|---|---|---|
| SYH2072 group | Experimental | Drug: SYH2072 tablets, Drug: PlaceboSYH2072 Tablets |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo |
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 or older; male or female.
- Documented diagnosis of primary aldosteronism (PA) before screening.
- Receiving stable antihypertensive therapy.
- Willing to discontinue mineralocorticoid receptor antagonists (MRA) or potassium-sparing diuretics.
- Mean seated office systolic blood pressure (SBP) ≥140 mmHg and <180 mmHg, and mean seated office diastolic blood pressure (DBP) <110 mmHg before randomization.
Key exclusion criteria (21 listed)
- Night shift workers.
- Known secondary causes of hypertension other than PA.
- Hypotension.
- Known hypersensitivity or allergic constitution.
- History of adrenal surgery, renal denervation, or similar procedures.
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 |
|---|---|---|
| SYH2072 tabletsSYH2072 tablets administered orally, once daily (QD) | Drug | SYH2072 group |
| PlaceboPlacebo administered orally, once daily (QD). | Drug | Placebo group, SYH2072 group |
Primary outcome
Change from baseline in seated Systolic Blood Pressure (SBP) at Week 8
Time frame: week 8
To evaluate the efficacy of SYH2072 tablets in improving blood pressure in trial participants with primary aldosteronism (PA) in China.
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 6 Nov 2026.
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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.
Yuguo Chen, Medical Doctor study chair
Qilu Hospital of Shandong University
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 SYH2072 tablets in people with Primary Aldosteronism, run by InnovStone Therapeutics Limited 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 21 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 6 Nov 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 Clinical Trials Information Group NA officer (86-311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in seated Systolic Blood Pressure (SBP) at Week 8 (time frame: week 8). 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 6 Nov 2026.