A Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Primary Aldosteronism

NCT07646535 | Not Yet Recruiting Phase 2

• 1 other identifier: SAL0140C201
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase II study designed to explore the efficacy and safety of different doses of SAL0140 in primary aldosteronism.

Conditions

Primary Aldosteronism

Keywords

Primary Aldosteronism; Aldosterone Synthase Inhibitor; Renin

Outcome Measures

Primary Outcomes (1)

• The baseline change in mean seated systolic blood pressure (msSBP)

  Change from baseline in mean seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment

  at week 12

Study Arms (3)

Low-dose group

EXPERIMENTAL

Drug: SAL0140 Tablets

High-dose group

EXPERIMENTAL

Drug: SAL0140 Tablets

Placebo group

PLACEBO COMPARATOR

Drug: SAL0140 placebo

Interventions

SAL0140 Tablets DRUG

Drug: SAL0140 Tablets

Low-dose group

SAL0140 placebo DRUG

Placebo

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years , regardless of gender.
• Diagnosed with primary aldosteronism (PA).
• Mean seated office systolic blood pressure (msSBP) ≥145 mmHg.
• Receiving stable background antihypertensive therapy.
• Serum potassium tested at local laboratory ≥3.0 mmol/L and \<5.0 mmol/L.
• Morning serum cortisol \>3 μg/dL.
• Voluntarily participate in the trial and provide written informed consent. Agree to comply with trial contraception and reproductive restrictions.

You may not qualify if:

• Mean seated office systolic blood pressure (msSBP) ≥180 mmHg and/or mean seated office diastolic blood pressure (msDBP) ≥110 mmHg.
• History or diagnosis of malignant hypertension, hypertensive emergency, hypertensive crisis or hypertensive encephalopathy.
• History or diagnostic evidence of other secondary hypertension.
• Prior surgical resection for adrenal adenoma.
• Medication compliance \<80% or \>120%.
• PA complicated with acute coronary syndrome, myocardial infarction, percutaneous coronary intervention or stroke.
• Receiving treatment with potassium-binding agents.
• Any clinically significant abnormal laboratory findings that, in the Investigator's opinion, may interfere with the evaluation of efficacy and/or safety endpoints of the study.
• Subjects with severe hepatobiliary diseases.
• Positive test for human immunodeficiency virus antibody (HIV), hepatitis C antibody (HCV), treponema pallidum antibody (TP), or positive hepatitis B surface antigen (HBsAg).
• Type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
• Morbid obesity.
• Receiving blood transfusion for anemia.
• History of adrenal insufficiency.
• History of solid organ or bone marrow transplantation.

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Central Study Contacts

Weiqing Wang, PhD

CONTACT

18917762201; wqingw61@163.com

Jiguang Wang, PhD

CONTACT

13764189476; jiguangw@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start: June 12, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)