Study of QLS1410 in the Treatment of Primary Aldosteronism.

NCT07550465 | Not Yet Recruiting Phase 2

• 1 other identifier: QLS1410-202
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Primary Aldosteronism

Outcome Measures

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

  at week 12

Study Arms (2)

QLS1410

EXPERIMENTAL

Drug: QLS1410

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

QLS1410 DRUG

QLS1410 tablet administered orally, once daily (QD).

QLS1410

Placebo DRUG

Placebo tablet administered orally, once daily (QD).

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Central Study Contacts

Ming Liu

CONTACT

+86-18322017516; mingliu@tmu.edu.cn

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: April 19, 2026
• First Posted: April 24, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-03