Obstructive Hypertrophic CardiomyopathyPhase 3NCT07021976
A Phase III Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy
A Phase 3 study testing HRS-1893 Tablets in people with Obstructive Hypertrophic Cardiomyopathy, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Obstructive Hypertrophic Cardiomyopathy
- What is being tested?
- HRS-1893 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2025to Nov 2026
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-85 years old, gender unlimited.
- BMI<35 kg/m2.
- The diagnosis was obstructive hypertrophic cardiomyopathy.
- Laboratory determination of echocardiography showed that Rest LVOT-G≥50 mmHg, or Rest LVOT-G≥30 mmHg and LVOT-G≥50 mmHg after Valsalva action.
- Echocardiographic laboratory tests showed LVEF≥60%.
- NYHA classification: Grade II - III.
- Understand the study procedure and sign the informed consent in person, willing to strictly follow the clinical study protocol to complete the study.
Who cannot join
- Known or suspected invasive, genetic or storage diseases (e.g. Noonan syndrome, Fabre's disease, amyloidosis) that cause cardiac hypertrophy (similar to oHCM).
- Had a history of severe valvular heart disease.
- Abnormal laboratory test results during screening, or any other clinically significant abnormal screening laboratory values, which are determined by the researcher to be unsuitable for inclusion.
- Other circumstances where the researchers consider the subjects unsuitable to participate in this trial, such as physical or mental illnesses or conditions that may increase the risk of the trial, affect the subjects' compliance with the protocol, or affect the subjects' completion of the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, 100032
About this study
Official title: A Multicentre, Randomized, Double-blind, Placebo-parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of HRS-1893 Tablets in the Treatment of Obstructive Hypertrophic Cardiomyopathy
The study is being conducted to evaluate the efficacy and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy.
- Conditions
- Obstructive Hypertrophic Cardiomyopathy
- Being tested
- HRS-1893 Tablets, HRS-1893 Placebo Tablets
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-1893 TabletsDrug
HRS-1893 tablets.
HRS-1893 Placebo TabletsDrug
HRS-1893 placebo tablets.
| Study group | Role | What they receive |
|---|---|---|
| HRS-1893 Group | Experimental | Not described Receives: Drug: HRS-1893 Tablets |
| HRS-1893 Placebo Group | Placebo comparator | Not described Receives: Drug: HRS-1893 Placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical response rate of treatment with HRS-1893.
Measured: After 24 weeks of HRS-1893 treatment.
Secondary outcomes (3)
The incidence of major adverse cardiac events (cardiovascular death, cardiac arrest, non-fatal stroke, non-fatal myocardial infarction, hospitalization for cardiovascular events).
Measured: About 29 weeks.
Incidence and severity of any adverse events.
Measured: About 29 weeks.
The change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) from the baseline.
Measured: Week 12 and Week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start11 Aug 2025
- Primary completionSep 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 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
- NCT07021976
- Sponsor's protocol ID
- HRS-1893-301
- Status last verified
- Aug 2026
- First submitted
- 6 Jun 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 Multicentre, Randomized, Double-blind, Placebo-parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of HRS-1893 Tablets in the Treatment of Obstructive Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT07021976
- Acronym / sponsor ID
- HRS-1893-301
- Conditions
- Obstructive Hypertrophic Cardiomyopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 15 Jun 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.
The study is being conducted to evaluate the efficacy and safety of HRS-1893 for 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
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS-1893 Group | Experimental | Drug: HRS-1893 Tablets |
| HRS-1893 Placebo Group | Placebo comparator | Drug: HRS-1893 Placebo Tablets |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-85 years old, gender unlimited.
- BMI<35 kg/m2.
- The diagnosis was obstructive hypertrophic cardiomyopathy.
- Laboratory determination of echocardiography showed that Rest LVOT-G≥50 mmHg, or Rest LVOT-G≥30 mmHg and LVOT-G≥50 mmHg after Valsalva action.
- Echocardiographic laboratory tests showed LVEF≥60%.
Key exclusion criteria (4 listed)
- Known or suspected invasive, genetic or storage diseases (e.g. Noonan syndrome, Fabre's disease, amyloidosis) that cause cardiac hypertrophy (similar to oHCM).
- Had a history of severe valvular heart disease.
- Abnormal laboratory test results during screening, or any other clinically significant abnormal screening laboratory values, which are determined by the researcher to be unsuitable for inclusion.
- Other circumstances where the researchers consider the subjects unsuitable to participate in this trial, such as physical or mental illnesses or conditions that may increase the risk of the trial, affect the subjects' compliance with the protocol, or affect the subjects' completion of the 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-1893 TabletsHRS-1893 tablets. | Drug | HRS-1893 Group |
| HRS-1893 Placebo TabletsHRS-1893 placebo tablets. | Drug | HRS-1893 Placebo Group |
Primary outcome
The clinical response rate of treatment with HRS-1893.
Time frame: After 24 weeks of HRS-1893 treatment.
3 secondary outcomes
The incidence of major adverse cardiac events (cardiovascular death, cardiac arrest, non-fatal stroke, non-fatal myocardial infarction, hospitalization for cardiovascular events).
Time frame: About 29 weeks.
Incidence and severity of any adverse events.
Time frame: About 29 weeks.
The change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) from the baseline.
Time frame: Week 12 and Week 24.
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 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 3 study testing HRS-1893 Tablets in people with 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 7 inclusion and 4 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: under way, not looking for participants, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
The clinical response rate of treatment with HRS-1893. (time frame: After 24 weeks of HRS-1893 treatment.). 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.