ClinicalTrials.gg
RecruitingNCT07708441Updated Oct 20, 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.. Recruiting at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Shandong Suncadia Medicine Co., Ltd. (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 20, 2026Now RecruitingSite recruiting status changedGo to Updates ↓
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

Browse trials for

03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's planned enrollment of 914 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Shandong Suncadia Medicine Co., Ltd. is the lead sponsor of 87 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
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. 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. (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 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 product, including but not limited to: respiratory, digestive, endocrine, immune, urinary, hematologic, neurologic, or psychiatric disorders.
  11. History of within 5 years prior to screening.
  12. Use of strong inhibitors/inducers of cytochrome P450 3A4 () 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. \< 45 mL/min/1.73 m² ;
    2. > 10.5%;
    3. Serum sodium \< 135.0 mmol/L;
    4. ≥ 3 × ;
    5. AST ≥ 3 × ULN;
    6. Total ≥ 2 × ULN.
  18. (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 .
  21. Treatment with any other investigational product within 90 days or 5 half-lives prior to screening .
  22. Women of (WOCBP) who are pregnant, breastfeeding, plan to become pregnant during the study, or are unable to use highly effective 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.
Terms in these criteria, in plain language(14)

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.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

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.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

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.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

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

06

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

07

Study locations

2 of 2 sites recruiting
  • Army Characteristic Medical Center of the People's Liberation Army
    Chongqing, Chongqing Municipality 400042, China
    Recruiting
    • Chunyu Zeng · Principal investigator
  • Zhongshan Hospital, Fudan University
    Shanghai, Shanghai Municipality 200080, China
    Recruiting
    • Xiaoqiang Ding · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 20, 2026
Sites
2 sites changed recruiting status (2 now recruiting)
Show 2 sites
  • Army Characteristic Medical Center of the People's Liberation Army · Chongqing, Chinano status→Recruiting
  • Zhongshan Hospital, Fudan University · Shanghai, Chinano status→Recruiting
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Not yet recruiting→Recruiting
    2 sites changed recruiting status (2 now recruiting)
    Show 2 sites
    • Army Characteristic Medical Center of the People's Liberation Army · Chongqing, Chinano status→Recruiting
    • Zhongshan Hospital, Fudan University · Shanghai, Chinano status→Recruiting
    + 1 other change: date precision

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 ↗

10

Registry details

Key details

Study ID
NCT07708441
Responsible party
Sponsor
First posted
Jul 16, 2026
Start date
Sep 29, 2026
Primary completion
Apr 2029 (estimated)
Completion
Apr 2029 (estimated)
Last update
Oct 20, 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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Studies of the drug tested here: HRS-1780

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