A Phase II Clinical Study on the Efficacy and Safety of HRS-1780 in Participants With Primary Aldosteronism

August 26, 2026 updated by: Shandong Suncadia Medicine Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Principal Investigator:
          • Qifu Li
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Principal Investigator:
          • Guijun Qin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female, aged ≥ 18 years on the date of signing the informed consent form.
  2. Diagnosed with primary aldosteronism.
  3. Not having taken antihypertensive medication prior to randomization, or having been on a stable antihypertensive regimen .
  4. 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.
  5. 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.

Exclusion Criteria:

  1. Has known secondary causes of hypertension.
  2. Has previously undergone, or plans to undergo during the study period, adrenal-related surgeries, including adrenalectomy, adrenal ablation, etc.
  3. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m².
  4. Has had any malignancy of an organ system within 5 years before screening.
  5. Has received any other investigational drug within 90 days or 5 half-lives before screening (whichever is longer).
  6. 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.
  7. Known or suspected alcohol or narcotic abuse.
  8. 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.
  9. Abnormal daily routine.
  10. Use of strong inhibitors/inducers of cytochrome P450 3A4 (CYP3A4) within 1 week before randomization.
  11. Severe infection, severe trauma, or major or medium-scale surgery within 1 month prior to screening;
  12. 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;
  13. 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;
  14. 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;
  15. Alanine aminotransferase (ALT) ≥ 3 × upper limit of normal (ULN);
  16. Aspartate aminotransferase (AST) ≥ 3 × ULN;
  17. 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: HRS-1780 Tablets
Drug: HRS-1780 Tablets
HRS-1780 Tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in office systolic blood pressure (SBP);
Time Frame: up to Week 8
up to Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Rate of achieving office blood pressure <140/90 mmHg;
Time Frame: up to Week 8
up to Week 8
Rate of achieving office blood pressure <130/80 mmHg;
Time Frame: up to Week 8
up to Week 8
Change from baseline in office diastolic blood pressure (DBP) ;
Time Frame: up to Week 8
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
up to Week 8
Change from baseline in 24-hour ABPM daytime and nighttime SBP and DBP ;
Time Frame: up to Week 8
up to Week 8
Change from baseline in serum potassium (K+) and serum sodium ;
Time Frame: Weeks 2, 4, and 8
Weeks 2, 4, and 8
Total cumulative dose of potassium supplement (potassium chloride) ;
Time Frame: up to Week 8
up to Week 8
Proportion of participants with a ≥30% decline in estimated glomerular filtration rate (eGFR);
Time Frame: up to Week 8
up to Week 8
Proportion of participants with 5.5 < K+ ≤ 6.0 mmol/L;
Time Frame: up to Week 8
up to Week 8
Proportion of participants with K+ > 6.0 mmol/L;
Time Frame: up to Week 8
up to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shandong Suncadia Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HRS-1780-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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