Primary AldosteronismPhase 2NCT07550465
Study of QLS1410 in the Treatment of Primary Aldosteronism.
A Phase 2 study testing QLS1410 in people with Primary Aldosteronism, run by Qilu Pharmaceutical Co., Ltd..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- QLS1410
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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.
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
- Being tested
- QLS1410, Placebo
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS1410Drug
QLS1410 tablet administered orally, once daily (QD).
PlaceboDrug
Placebo tablet administered orally, once daily (QD).
| Study group | Role | What they receive |
|---|---|---|
| QLS1410 | Experimental | Not described Receives: Drug: QLS1410 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study startJun 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550465
- Sponsor's protocol ID
- QLS1410-202
- Status last verified
- Mar 2026
- First submitted
- 19 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07550465
- Acronym / sponsor ID
- QLS1410-202
- Conditions
- Primary Aldosteronism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLS1410 | Experimental | Drug: QLS1410 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QLS1410QLS1410 tablet administered orally, once daily (QD). | Drug | QLS1410 |
| PlaceboPlacebo tablet administered orally, once daily (QD). | Drug | Placebo |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QLS1410 in people with Primary Aldosteronism, run by Qilu Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Liu (+86-18322017516, mingliu@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in seated Systolic Blood Pressure (SBP) at Week 12 (time frame: at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.