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

Official title

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

Overview

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.

Interventions

• Drug HRS-1780 Tablets
  HRS-1780 Tablets
• Drug Placebo
  Placebo

Primary outcome measures

• Change from baseline in office systolic blood pressure (SBP); [Time frame: up to Week 8]

Secondary outcome measures (10)

• Rate of achieving office blood pressure <140/90 mmHg; [Time frame: up to Week 8]
• Rate of achieving office blood pressure <130/80 mmHg; [Time frame: up to Week 8]
• Change from baseline in office diastolic blood pressure (DBP) ; [Time frame: 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]
• Change from baseline in 24-hour ABPM daytime and nighttime SBP and DBP ; [Time frame: up to Week 8]
• Change from baseline in serum potassium (K+) and serum sodium ; [Time frame: Weeks 2, 4, and 8]
• Total cumulative dose of potassium supplement (potassium chloride) ; [Time frame: up to Week 8]
• Proportion of participants with a ≥30% decline in estimated glomerular filtration rate (eGFR); [Time frame: up to Week 8]
• Proportion of participants with 5.5 < K+ ≤ 6.0 mmol/L; [Time frame: up to Week 8]
• Proportion of participants with K+ > 6.0 mmol/L; [Time frame: up to Week 8]

Eligibility criteria

Inclusion criteria

• Male or female, aged ≥ 18 years on the date of signing the informed consent form.
• Diagnosed with primary aldosteronism.
• No use of antihypertensive drugs before screening, or stable use of antihypertensive drugs.
• 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.
• 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 2 centers

• The First Affiliated Hospital of Chongqing Medical University — Chongqing
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou

Identifiers

NCT: NCT07470983 · HRS-1780-203

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗