Study of QLS1410 in the Treatment of Primary Aldosteronism.

This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of QLS1410 versus placebo, on the reduction of Seated Blood Pressure (SBP) in participants ≥ 18 years of age with Primary Aldosteronism (PA) with or without prior treatment with Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics.

QLS1410 (or placebo) will be administered once daily, up-titrated after 2 weeks or 4 weeks based on clinical response and tolerability.

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Key information

Conditions

Primary Aldosteronism Adrenal Gland Diseases Adrenocortical Hyperfunction Endocrine System Diseases Hyperaldosteronism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female participants must be ≥ 18 years of age
Participants with a documented diagnosis of primary aldosteronism (PA) that fulfils the criteria Guidelines.
Participants willing and able to cease dosing of mineralocorticoid receptor antagonist (MRA) or potassium sparing diuretics per study requirement for participants taking an MRA or potassium sparing diuretic at Screening.
eGFR ≥ 45 mL/min/1.73m2 at Screening
Have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomization

Exclusion criteria

Had undergone surgery for adrenal adenoma in the past or planned to receive surgical treatments such as adrenalectomy, renal sympathetic denervation, or adrenal ablation during the course of the study.
Has the following known secondary causes of HTN: renal artery stenosis, uncontrolled or untreated hyperthyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.
Treatment with any MRA or potassium-sparing diuretic within 2 weeks prior to Randomization.

Treatment and study plan

QLS1410

Drug

QLS1410 tablet administered orally, once daily (QD).

Placebo

Drug

Placebo tablet administered orally, once daily (QD).

Primary outcomes

Change from baseline in seated Systolic Blood Pressure (SBP) at Week 12

Time frame: at week 12

To assess the effect of baxdrostat versus placebo on seated Systolic Blood Pressure (SBP) at Week 12

Study contacts

Contact information is provided by the study sponsor or research team.

Ming Liu

CONTACT

[email protected]

+86-18322017516

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of QLS1410 Tablets in the Treatment of Patients With Primary Aldosteronism.

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Apr 24, 2026
Registry last updated: Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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