> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-trial-of-hrs-1780-in-participants-with-uncontrolled-9e04bcd0-3c8b-45fb-a61d-8078319c1ee8 > Record changed: 2026-10-13 # A Trial of HRS-1780 in Participants With Uncontrolled Hypertension or Resistant Hypertension. NCT07708441 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) Phase Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) Participants 914 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) Lead sponsor Shandong Suncadia Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) Start date 2026-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) ## Title and summary **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。 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) **Short title** A Trial of HRS-1780 in Participants With Uncontrolled Hypertension or Resistant Hypertension. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) **Official title** A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of HRS-1780 in Participants With Uncontrolled Hypertension or Resistant Hypertension. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) **Phase** Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) ## Dates **Completion date** 2029-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) **First posted** 2026-07-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) **Registry last updated** 2026-07-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) **Primary completion date** 2029-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) **Start date** 2026-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) ## Size and sites **Participants** 914 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) **Planned participants** 914 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) **Lead sponsor** Shandong Suncadia Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) ## Identifiers **Registry ID** NCT07708441 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) **ClinicalTrials.gov ID** NCT07708441 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) ## Outcomes ### Primary outcomes 1. Change from baseline in trough seated SBP at Week 12 Timeframe: baseline and Week 12 ### Secondary outcomes 1. Change from baseline in trough seated DBP at Week 12 Timeframe: baseline and Week 12 2. Change from baseline in trough seated SBP at Week 8 Timeframe: baseline and Week 8 3. Proportion of participants achieving trough seated blood pressure < 140/90 mmHg at Week 12 Timeframe: Week 12 4. Proportion of participants achieving trough seated SBP < 130 mmHg at Week 12 Timeframe: Week 12 5. Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) mean SBP at Week 12 Timeframe: baseline and Week 12 6. Change from baseline in daytime and nighttime mean SBP measured by 24-hour ABPM at Week 12 Timeframe: baseline and Week 12 7. Change from baseline in daytime and nighttime mean DBP measured by 24-hour ABPM at Week 12 Timeframe: baseline and Week 12 8. Change from randomized withdrawal baseline (Week 44) in trough seated SBP at Week 52 Timeframe: Week 44 and Week 52 9. Proportion of participants with eGFR decline ≥ 30% during the treatment period Timeframe: baseline and treatment period 10. Proportion of participants with serum potassium > 6.0 mmol/L during the treatment period Timeframe: treatment period 11. Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) mean DBP at Week 12 Timeframe: baseline and Week 12 12. Proportion of participants with serum potassium > 5.5 mmol/L and ≤ 6.0 mmol/L during the treatment period Timeframe: treatment period Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 80 Years **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 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) ## Sites - Army Characteristic Medical Center of the People's Liberation ArmyChongqing, China - Zhongshan Hospital, Fudan UniversityShanghai, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708441) ## Related records ### Drugs (1) - [LB-102](https://trialight.com/data/asset/lb-102-4fafa13e-2b6e-4289-b389-c2f1e2b594e9.md) ### Lead sponsors (1) - [Shandong Suncadia Medicine Co., Ltd.](https://trialight.com/data/company/shandong-suncadia-medicine-co-ltd-c4ebee86-20f2-45b5-9857-30794a216c9a.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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