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Not yet recruitingNCT07708441Updated Sep 1, 2026

A Trial of HRS-1780 in Participants With Uncontrolled Hypertension or Resistant Hypertension.

A Phase 2/3 interventional study of HRS-1780 tablet and HRS-1780 tablet in Uncontrolled or Resistant Hypertension, sponsored by Shandong Suncadia Medicine Co., Ltd.. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Shandong Suncadia Medicine Co., Ltd. · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
914
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The study is being conducted to evaluate the efficacy and safety of HRS-1780 in participants with uncontrolled hypertension or resistant hypertension. To explore the optimal use of HRS-1780 in participants with uncontrolled hypertension or resistant hypertension。

02

Conditions studied

  • Uncontrolled or Resistant Hypertension
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female, aged ≥ 18 and \< 80 years ;
  2. Mean trough seated SBP ≥ 140 mmHg and \< 170 mmHg at both screening and randomization visits.
  3. Meet one of the following two criteria:

    1. Meet the criteria for uncontrolled hypertension;
    2. Meet the criteria for resistant hypertension;
  4. Serum potassium ≥ 3.5 mmol/L and ≤ 5.0 mmol/L ;
  5. Voluntarily sign the ICF prior to the study;
  6. Have no plan for fertility from the time of signing the ICF until 4 weeks after the last dose.

Exclusion criteria

Exclusion Criteria:

  1. Mean trough seated DBP ≥ 110 mmHg at randomization.
  2. Have a known secondary cause of hypertension, including but not limited to: renal artery stenosis, coarctation of the aorta, uncontrolled or untreated hyperthyroidism/hypothyroidism, pheochromocytoma, or Cushing's syndrome.
  3. History of adrenal insufficiency at screening.
  4. Presence of severe structural heart disease at screening, including severe valvular heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, rheumatic heart disease, or congenital heart disease.
  5. Presence of persistent atrial fibrillation or any arrhythmia requiring treatment at screening; or resting heart rate \< 45 bpm or > 110 bpm.
  6. New York Heart Association (NYHA) Class III-IV heart failure at screening.
  7. Undergone CT angiography (CTA) or colonoscopy within 1 month prior to screening.
  8. Undergone percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 6 months prior to screening, or plan to undergo PCI, CABG, carotid or peripheral artery revascularization during the study period.
  9. History of stroke, acute coronary syndrome, hypertensive encephalopathy, or hospitalization for heart failure within 6 months prior to screening.
  10. Within 6 months prior to screening, presence of clinically significant diseases in the following systems that, in the investigator's judgment, may interfere with the study results or pose additional risk to the administration of the investigational product, including but not limited to: respiratory, digestive, endocrine, immune, urinary, hematologic, neurologic, or psychiatric disorders.
  11. History of malignancy within 5 years prior to screening.
  12. Use of strong inhibitors/inducers of cytochrome P450 3A4 (CYP3A4) within 1 week prior to screening ,or moderate inhibitors/inducers.
  13. Use of mineralocorticoid receptor antagonists (MRAs) and/or potassium-sparing diuretics (e.g., spironolactone, eplerenone, finerenone, amiloride, triamterene, etc.) within 4 weeks prior to randomization.
  14. Use of aldosterone synthase inhibitors (ASIs) within 4 weeks prior to randomization.
  15. Concomitant use of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) within 4 weeks prior to randomization.
  16. Treatment with potassium binders within 2 months prior to screening.
  17. Presence of any of the following laboratory abnormalities:

    1. eGFR \< 45 mL/min/1.73 m² ;
    2. HbA1c > 10.5%;
    3. Serum sodium \< 135.0 mmol/L;
    4. ALT ≥ 3 × ULN;
    5. AST ≥ 3 × ULN;
    6. Total bilirubin ≥ 2 × ULN.
  18. Body mass index (BMI) > 35 kg/m².
  19. Run-in period placebo compliance \< 80% or > 120% at randomization.
  20. Known or suspected allergy to MRAs, the investigational product, or any of its excipients.
  21. Treatment with any other investigational product within 90 days or 5 half-lives prior to screening .
  22. Women of childbearing potential (WOCBP) who are pregnant, breastfeeding, plan to become pregnant during the study, or are unable to use highly effective contraceptive measures; or male participants who are unable to use highly effective contraceptive measures.
  23. Occupation or working schedule requiring regular night shifts or similar circumstances that may interfere with study procedures.
  24. Any other condition that, in the investigator's judgment, may compromise participant safety or interfere with the assessment of study results.
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
914 participants (estimated)

Study arms

  • Experimental
    Treatment group A: HRS-1780 tablet Dose 1

    Drug: HRS-1780 tablet

  • Experimental
    Treatment group B: HRS-1780 tablet Dose 2

    Drug: HRS-1780 tablet

  • Experimental
    Treatment group C: HRS-1780 tablet Dose 3

    Drug: HRS-1780 tablet

  • Placebo comparator
    Treatment group D: HRS-1780 tablet placebo

    Drug: HRS-1780 tablet placebo

Interventions

  • DrugHRS-1780 tablet

    HRS-1780 tablet Dose 1

  • DrugHRS-1780 tablet

    HRS-1780 tablet Dose 2

  • DrugHRS-1780 tablet

    HRS-1780 tablet Dose 3

  • DrugHRS-1780 tablet placebo

    HRS-1780 tablet placebo

05

What researchers measure

Primary outcomes

  1. Change from baseline in trough seated SBP at Week 12

    Time frame: baseline and Week 12

Secondary outcomes

  1. Change from baseline in trough seated DBP at Week 12

    Time frame: baseline and Week 12

  2. Change from baseline in trough seated SBP at Week 8

    Time frame: baseline and Week 8

  3. Proportion of participants achieving trough seated blood pressure < 140/90 mmHg at Week 12

    Time frame: Week 12

  4. Proportion of participants achieving trough seated SBP < 130 mmHg at Week 12

    Time frame: Week 12

  5. Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) mean SBP at Week 12

    Time frame: baseline and Week 12

  6. Change from baseline in daytime and nighttime mean SBP measured by 24-hour ABPM at Week 12

    Time frame: baseline and Week 12

  7. Change from baseline in daytime and nighttime mean DBP measured by 24-hour ABPM at Week 12

    Time frame: baseline and Week 12

  8. Change from randomized withdrawal baseline (Week 44) in trough seated SBP at Week 52

    Time frame: Week 44 and Week 52

  9. Proportion of participants with eGFR decline ≥ 30% during the treatment period

    Time frame: baseline and treatment period

  10. Proportion of participants with serum potassium > 6.0 mmol/L during the treatment period

    Time frame: treatment period

  11. Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) mean DBP at Week 12

    Time frame: baseline and Week 12

  12. Proportion of participants with serum potassium > 5.5 mmol/L and ≤ 6.0 mmol/L during the treatment period

    Time frame: treatment period

06

Study locations

2 sites
  • Army Characteristic Medical Center of the People's Liberation Army
    Chongqing, Chongqing Municipality 400042, China
    • Chunyu Zeng · Principal investigator
  • Zhongshan Hospital, Fudan University
    Shanghai, Shanghai Municipality 200080, China
    • Xiaoqiang Ding · Principal investigator
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07708441
Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Jul 16, 2026
Start date
Sep 2026 (estimated)
Primary completion
Apr 2029 (estimated)
Completion
Apr 2029 (estimated)
Last update
Sep 1, 2026

Study contacts

Xue Dong
Contact
xue.dong@hengrui.com
13511659605
Ru Lin
Contact
ru.lin.rl7@hengrui.com
15521381683

Oversight

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

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