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Not yet recruitingNCT07550465Updated Apr 24, 2026

Study of QLS1410 in the Treatment of Primary Aldosteronism.

A Phase 2 interventional study of QLS1410 and Placebo in Primary Aldosteronism, sponsored by Qilu Pharmaceutical Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Primary Aldosteronism

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female participants must be ≥ 18 years of age
  2. Participants with a documented diagnosis of primary aldosteronism (PA) that fulfils the criteria Guidelines.
  3. 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.
  4. eGFR ≥ 45 mL/min/1.73m2 at Screening
  5. Have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomization

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Has the following known secondary causes of HTN: renal artery stenosis, uncontrolled or untreated hyperthyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.
  3. Treatment with any MRA or potassium-sparing diuretic within 2 weeks prior to Randomization.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    QLS1410

    Drug: QLS1410

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugQLS1410

    QLS1410 tablet administered orally, once daily (QD).

  • DrugPlacebo

    Placebo tablet administered orally, once daily (QD).

05

What researchers measure

Primary outcomes

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

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

    Time frame: at week 12

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07550465
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Apr 24, 2026
Start date
Jun 2026 (estimated)
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Apr 24, 2026

Study contacts

Ming Liu
Contact
mingliu@tmu.edu.cn
+86-18322017516

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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