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

Starting soon · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Uncontrolled or Resistant Hypertension

In brief

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。

Key facts

Study ID

NCT07708441

Run by

Shandong Suncadia Medicine Co., Ltd.

People needed

914

Starts

2026-07-01

Expected to finish

2029-04-01

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, aged ≥ 18 and < 80 years ；
• Mean trough seated SBP ≥ 140 mmHg and < 170 mmHg at both screening and randomization visits.
• Meet one of the following two criteria:
• Meet the criteria for uncontrolled hypertension；
• Meet the criteria for resistant hypertension；
• Serum potassium ≥ 3.5 mmol/L and ≤ 5.0 mmol/L ；
• Voluntarily sign the ICF prior to the study；
• Have no plan for fertility from the time of signing the ICF until 4 weeks after the last dose.

You may not qualify if…

• Mean trough seated DBP ≥ 110 mmHg at randomization.
• 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.
• History of adrenal insufficiency at screening.
• Presence of severe structural heart disease at screening, including severe valvular heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, rheumatic heart disease, or congenital heart disease.
• Presence of persistent atrial fibrillation or any arrhythmia requiring treatment at screening; or resting heart rate < 45 bpm or > 110 bpm.
• New York Heart Association (NYHA) Class III-IV heart failure at screening.
• Undergone CT angiography (CTA) or colonoscopy within 1 month prior to screening.
• 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.
• History of stroke, acute coronary syndrome, hypertensive encephalopathy, or hospitalization for heart failure within 6 months prior to screening.
• 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.
• History of malignancy within 5 years prior to screening.
• Use of strong inhibitors/inducers of cytochrome P450 3A4 (CYP3A4) within 1 week prior to screening ,or moderate inhibitors/inducers.
• 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.
• Use of aldosterone synthase inhibitors (ASIs) within 4 weeks prior to randomization.
• Concomitant use of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) within 4 weeks prior to randomization.
• Treatment with potassium binders within 2 months prior to screening.
• Presence of any of the following laboratory abnormalities:
• eGFR < 45 mL/min/1.73 m² ;
• HbA1c > 10.5%;
• Serum sodium < 135.0 mmol/L;
• ALT ≥ 3 × ULN;
• AST ≥ 3 × ULN;
• Total bilirubin ≥ 2 × ULN.
• Body mass index (BMI) > 35 kg/m².
• Run-in period placebo compliance < 80% or > 120% at randomization.

Where it is running

• Army Characteristic Medical Center of the People's Liberation Army — Chongqing, Chongqing Municipality, China
• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

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