Non-obstructive Hypertrophic CardiomyopathyPhase 2NCT06816251
A Phase II Clinical Study of HRS-1893 in Non-obstructive Hypertrophic Cardiomyopathy
A Phase 2 study testing HRS-1893 in people with Non-obstructive Hypertrophic Cardiomyopathy, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
This study mainly evaluated the safety and tolerability of HRS-1893 in subjects with non-obstructive hypertrophic cardiomyopathy, and the efficacy and plasma concentrations of different dosing regimens in subjects with non-obstructive hypertrophic cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non-obstructive Hypertrophic Cardiomyopathy
- What is being tested?
- HRS-1893
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2025to 18 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18~85 years old (including boundary value), male or female.
- Body mass index < 35 kg/m2.
- Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.
- Female subjects of childbearing potential must have a serum pregnancy test prior to the first dose with a negative result and must be non-lactating during the study.
- Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to refrain from donating sperm/eggs from the time of signing the informed consent form until 3 months after the last dose of the trial drug, and comply with the relevant contraceptive requirements.
Who cannot join
- Known or suspected infiltration, hereditary, or storage disorder that can cause myocardial hypertrophy.
- Paroxysmal atrial flutter or atrial fibrillation with clinical symptoms at screening.
- History of syncope or sustained ventricular tachycardia within 6 months prior to screening.
- Those who have participated in the clinical trial of any drug or medical device within 3 months before screening.
- Other conditions that the investigator considers the subject to be unsuitable for participating in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS-1893 in Non-Obstructive Hypertrophic Cardiomyopathy
This study mainly evaluated the safety and tolerability of HRS-1893 in subjects with non-obstructive hypertrophic cardiomyopathy, and the efficacy and plasma concentrations of different dosing regimens in subjects with non-obstructive hypertrophic cardiomyopathy.
- Being tested
- HRS-1893, HRS-1893 placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-1893Drug
HRS-1893 tablet.
HRS-1893 placeboDrug
HRS-1893 tablet placebo.
| Study group | Role | What they receive |
|---|---|---|
| HRS-1893 low-dose group | Experimental | Not described Receives: Drug: HRS-1893 |
| HRS-1893 placebo low-dose group | Placebo comparator | Not described Receives: Drug: HRS-1893 placebo |
| HRS-1893 high-dose group | Experimental | Not described Receives: Drug: HRS-1893 |
| HRS-1893 placebo high-dose group | Placebo comparator | Not described Receives: Drug: HRS-1893 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Measured: Up to 14 weeks.
The incidence of left ventricular ejection fraction (LVEF) < 50%
Measured: Up to 14 weeks.
Secondary outcomes (2)
Peak oxygen uptake (pVO2) value
Measured: About 12 weeks.
The cardiac troponin value
Measured: About 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start25 Feb 2025
- Primary completion18 Nov 2025
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-obstructive Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816251
- Sponsor's protocol ID
- HRS-1893-202
- Status last verified
- Aug 2026
- First submitted
- 4 Feb 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS-1893 in Non-Obstructive Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06816251
- Acronym / sponsor ID
- HRS-1893-202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 10 Feb 2025 (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 study mainly evaluated the safety and tolerability of HRS-1893 in subjects with non-obstructive hypertrophic cardiomyopathy, and the efficacy and plasma concentrations of different dosing regimens in subjects with non-obstructive hypertrophic cardiomyopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HRS-1893 low-dose group | Experimental | Drug: HRS-1893 |
| HRS-1893 placebo low-dose group | Placebo comparator | Drug: HRS-1893 placebo |
| HRS-1893 high-dose group | Experimental | Drug: HRS-1893 |
| HRS-1893 placebo high-dose group | Placebo comparator | Drug: HRS-1893 placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18~85 years old (including boundary value), male or female.
- Body mass index < 35 kg/m2.
- Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.
- Female subjects of childbearing potential must have a serum pregnancy test prior to the first dose with a negative result and must be non-lactating during the study.
- Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to refrain from donating sperm/eggs from the time of signing the informed consent form until 3 months after the last dose of the trial drug, and comply with the relevant contraceptive requirements.
Key exclusion criteria (5 listed)
- Known or suspected infiltration, hereditary, or storage disorder that can cause myocardial hypertrophy.
- Paroxysmal atrial flutter or atrial fibrillation with clinical symptoms at screening.
- History of syncope or sustained ventricular tachycardia within 6 months prior to screening.
- Those who have participated in the clinical trial of any drug or medical device within 3 months before screening.
- Other conditions that the investigator considers the subject to be unsuitable for participating in this trial.
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 |
|---|---|---|
| HRS-1893HRS-1893 tablet. | Drug | HRS-1893 high-dose group, HRS-1893 low-dose group |
| HRS-1893 placeboHRS-1893 tablet placebo. | Drug | HRS-1893 placebo high-dose group, HRS-1893 placebo low-dose group |
Primary outcome
Adverse events (AEs)
Time frame: Up to 14 weeks.
The incidence of left ventricular ejection fraction (LVEF) < 50%
Time frame: Up to 14 weeks.
2 secondary outcomes
Peak oxygen uptake (pVO2) value
Time frame: About 12 weeks.
The cardiac troponin value
Time frame: About 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-1893 in people with Non-obstructive Hypertrophic Cardiomyopathy, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
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 5 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: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: Up to 14 weeks.). The study lists 2 primary outcomes in all. 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 Aug 2026.