Primary AldosteronismPhase 2NCT07470983
A Phase II Clinical Study on the Efficacy and Safety of HRS-1780 in Participants With Primary Aldosteronism
A Phase 2 study testing HRS-1780 Tablets in people with Primary Aldosteronism, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites in China.
Trial summary
This study is a multicenter, randomized, double-blind, placebo-parallel-controlled phase II clinical trial to evaluate the efficacy and safety of HRS-1780 compared with placebo in participants with primary aldosteronism. The study plans to enroll 60 participants. 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?
- HRS-1780 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 2 sitesChina
- Study dates
- 23 Apr 2026to Nov 2026
- 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
- Male or female, aged ≥ 18 years on the date of signing the informed consent form.
- Diagnosed with primary aldosteronism.
- Not having taken antihypertensive medication prior to randomization, or having been on a stable antihypertensive regimen .
- Voluntarily sign the informed consent form before the trial, fully understand the trial content, procedures, and possible adverse reactions, and be capable and willing to comply with the protocol requirements to complete the study.
- From the signing of the informed consent form until 4 weeks after the last dose, the participant has no plan for procreation and is willing to adopt the highly effective contraceptive measures specified in the protocol.
Who cannot join
- Has known secondary causes of hypertension.
- Has previously undergone, or plans to undergo during the study period, adrenal-related surgeries, including adrenalectomy, adrenal ablation, etc.
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m².
- Has had any malignancy of an organ system within 5 years before screening.
- Has received any other investigational drug within 90 days or 5 half-lives before screening (whichever is longer).
- Has a history of blood donation or blood loss ≥ 400 mL within 3 months before screening, or has received a blood transfusion within 2 months.
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- Known or suspected alcohol or narcotic abuse.
- Women who are pregnant, breastfeeding, planning pregnancy, or of childbearing potential unable to adopt highly effective contraceptive measures; or men unable to adopt highly effective contraceptive measures.
- Abnormal daily routine.
- Use of strong inhibitors/inducers of cytochrome P450 3A4 (CYP3A4) within 1 week before randomization.
- Severe infection, severe trauma, or major or medium-scale surgery within 1 month prior to screening;
- Stroke, transient ischemic attack, myocardial infarction, symptomatic heart failure (NYHA III-IV), or coronary revascularization within 3 months prior to screening; and/or planned coronary, carotid, or peripheral artery revascularization at the time of screening;
- Within 6 months prior to the screening period, participants have clinically significant diseases that, in the judgment of the investigator, may interfere with the trial results or pose additional risks to the administration of the study drug, including but not limited to respiratory, digestive, cardiovascular, endocrine, immune, urinary, adrenal (except for the primary disease), hematological, neurological, psychiatric, or other conditions;
- Presence or suspected presence of depression, bipolar disorder, suicidal tendencies, schizophrenia, or other severe mental disorders; or participants with mental incapacity or language barriers that prevent them from adequately understanding or participating in the trial process;
- Alanine aminotransferase (ALT) ≥ 3 × upper limit of normal (ULN);
- Aspartate aminotransferase (AST) ≥ 3 × ULN;
- In the judgment of the investigator, any condition that may affect participant safety or otherwise interfere with the evaluation of trial results (including medical, psychological, social, or geographical factors).
Trial locations and contacts
2 sites in 1 country.
China2 sites
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS-1780 in Participants With Primary Aldosteronism
This study is a multicenter, randomized, double-blind, placebo-parallel-controlled phase II clinical trial to evaluate the efficacy and safety of HRS-1780 compared with placebo in participants with primary aldosteronism. The study plans to enroll 60 participants.
- Conditions
- Primary Aldosteronism
- Being tested
- HRS-1780 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.
HRS-1780 TabletsDrug
HRS-1780 Tablets
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| HRS-1780 Tablets | Experimental | Not described Receives: Drug: HRS-1780 Tablets |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in office systolic blood pressure (SBP);
Measured: up to Week 8
Secondary outcomes (10)
Rate of achieving office blood pressure <140/90 mmHg;
Measured: up to Week 8
Rate of achieving office blood pressure <130/80 mmHg;
Measured: up to Week 8
Change from baseline in office diastolic blood pressure (DBP) ;
Measured: up to Week 8
Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) mean SBP and DBP ;
Measured: up to Week 8
Change from baseline in 24-hour ABPM daytime and nighttime SBP and DBP ;
Measured: up to Week 8
Change from baseline in serum potassium (K+) and serum sodium ;
Measured: Weeks 2, 4, and 8
Total cumulative dose of potassium supplement (potassium chloride) ;
Measured: up to Week 8
Proportion of participants with a ≥30% decline in estimated glomerular filtration rate (eGFR);
Measured: up to Week 8
Proportion of participants with 5.5 < K+ ≤ 6.0 mmol/L;
Measured: up to Week 8
Proportion of participants with K+ > 6.0 mmol/L;
Measured: up to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start23 Apr 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (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 Shandong Suncadia Medicine 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470983
- Sponsor's protocol ID
- HRS-1780-203
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS-1780 in Participants With Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT07470983
- Acronym / sponsor ID
- HRS-1780-203
- Conditions
- Primary Aldosteronism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 13 Mar 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 study is a multicenter, randomized, double-blind, placebo-parallel-controlled phase II clinical trial to evaluate the efficacy and safety of HRS-1780 compared with placebo in participants with primary aldosteronism. The study plans to enroll 60 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS-1780 Tablets | Experimental | Drug: HRS-1780 Tablets |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, aged ≥ 18 years on the date of signing the informed consent form.
- Diagnosed with primary aldosteronism.
- Not having taken antihypertensive medication prior to randomization, or having been on a stable antihypertensive regimen .
- Voluntarily sign the informed consent form before the trial, fully understand the trial content, procedures, and possible adverse reactions, and be capable and willing to comply with the protocol requirements to complete the study.
- From the signing of the informed consent form until 4 weeks after the last dose, the participant has no plan for procreation and is willing to adopt the highly effective contraceptive measures specified in the protocol.
Key exclusion criteria (17 listed)
- Has known secondary causes of hypertension.
- Has previously undergone, or plans to undergo during the study period, adrenal-related surgeries, including adrenalectomy, adrenal ablation, etc.
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m².
- Has had any malignancy of an organ system within 5 years before screening.
- Has received any other investigational drug within 90 days or 5 half-lives before screening (whichever is longer).
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 |
|---|---|---|
| HRS-1780 TabletsHRS-1780 Tablets | Drug | HRS-1780 Tablets |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change from baseline in office systolic blood pressure (SBP);
Time frame: up to Week 8
10 secondary outcomes
Rate of achieving office blood pressure <140/90 mmHg;
Time frame: up to Week 8
Rate of achieving office blood pressure <130/80 mmHg;
Time frame: up to Week 8
Change from baseline in office diastolic blood pressure (DBP) ;
Time frame: up to Week 8
Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) mean SBP and DBP ;
Time frame: up to Week 8
Change from baseline in 24-hour ABPM daytime and nighttime SBP and DBP ;
Time frame: up to Week 8
Change from baseline in serum potassium (K+) and serum sodium ;
Time frame: Weeks 2, 4, and 8
Total cumulative dose of potassium supplement (potassium chloride) ;
Time frame: up to Week 8
Proportion of participants with a ≥30% decline in estimated glomerular filtration rate (eGFR);
Time frame: up to Week 8
Proportion of participants with 5.5 < K+ ≤ 6.0 mmol/L;
Time frame: up to Week 8
Proportion of participants with K+ > 6.0 mmol/L;
Time frame: up to Week 8
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 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-1780 Tablets in people with Primary Aldosteronism, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites 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 17 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: under way, not looking for participants, as of the sponsor's last update on 13 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 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in office systolic blood pressure (SBP); (time frame: up to 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 13 Oct 2026.