Not Yet RecruitingPhase 2

Study of QLS1410 in the Treatment of Primary Aldosteronism.

60 participantsStarted 2026-06

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

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

Timeframe: at week 12

Trial details

NCT IDNCT07550465

SponsorQilu Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04

Contact for this trial

Ming Liu

+86-18322017516 mingliu@tmu.edu.cn

View on ClinicalTrials.gov More Primary Aldosteronism trials