Treatment of Lipoprotein DisorderPhase 2NCT06816264
A Study of HRS-5346 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events
A Phase 2 study testing HRS-5346 in people with Treatment of Lipoprotein Disorder, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The main purpose of this study is to evaluate the efficacy and safety of HRS-5346 in adult participants with elevated Lp(a) at high risk for cardiovascular events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment of Lipoprotein Disorder
- What is being tested?
- HRS-5346
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2025to 29 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understanding the specific procedures of the trial, voluntarily participating in this trial, and providing written informed consent;
- Being at least 18 years of age on the day of signing the informed consent form;
- Body Mass Index (BMI) within the range of 18.5 to 40 kg/m² (inclusive of boundary values);
- Participants must be at high risk of cardiovascular events, defined as individuals diagnosed with Atherosclerotic Cardiovascular Disease (ASCVD) and those at high risk for ASCVD.
- Participants (including their partners) are willing to voluntarily use highly effective contraceptive measures from the time of signing the informed consent form until 6 months after the last administration of the study drug; female participants must have a negative blood pregnancy test and must not be breastfeeding;
- Willing and able to comply with all the provisions of the protocol, including demonstrating the ability to adhere to study procedures prior to random assignment.
Who cannot join
- Medical History and Concomitant Medications
- Occurrence of any of the following events within 3 months prior to screening, or between screening and randomization, or any other event deemed by the investigator to indicate clinical instability: major cardiac or non-cardiac surgery, coronary, carotid, or peripheral artery revascularization, stroke or transient ischemic attack, myocardial infarction or unstable angina, acute limb ischemia;
- Planned or anticipated cardiac, cerebrovascular, or peripheral artery surgery or coronary revascularization or other major surgery after randomization;
- History of hemorrhagic stroke or other significant bleeding events;
- History of malignancy in any organ system (except well-treated basal cell carcinoma of the skin);
- History of diseases that significantly affect lipid levels, such as nephrotic syndrome, severe liver disease, Cushing's syndrome, etc.;
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- Uncontrolled type 1 or type 2 diabetes within 6 months prior to screening (including diabetic ketoacidosis or hyperosmolar hyperglycemic state or HbA1c > 8.5% at screening);
- History of acute kidney injury within 12 months prior to screening;
- Uncontrolled hyperthyroidism or hypothyroidism;
- Active infection requiring systemic antiviral or antibiotic therapy prior to randomization;
- New York Heart Association (NYHA) class III-IV heart function or most recent left ventricular ejection fraction (LVEF) < 30% at screening or prior to randomization;
- Use of weight-loss medications or surgery leading to weight instability within 2 months prior to screening;
- Long-term continuous or repeated use of systemic corticosteroids within 3 months prior to screening (excluding local use, such as intra-articular, nasal, inhaled, topical, etc.; long-term continuous means ≥7 days; repeated means cumulative use ≥3 times);
- Lipoprotein apheresis treatment within 3 months prior to screening, or planned to undergo this treatment during the study;
- Use of PCSK9 inhibitors within 12 months prior to screening;
- Allergy to the active ingredient of HRS-5346 or any excipient.
- Laboratory and Other Tests
- Uncontrolled hypertension at screening (sitting systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg);
- Severe renal insufficiency, defined as eGFR < 30 ml/min/1.73 m² (calculated using the CKD-EPI formula) at screening, or undergoing dialysis;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or γ-glutamyl transferase (GGT) more than 3 times the upper limit of normal (ULN), or total bilirubin more than 2 times the ULN;
- Positive test results for any of the following: human immunodeficiency virus antibody (HIV-Ab), hepatitis C virus antibody (HCV-Ab), Treponema pallidum antibody; positive hepatitis B virus surface antigen (HBsAg) with HBV-DNA ≥1000 copies/ml (or ≥200 IU/ml, if the lower limit of detection is higher than 1000 copies/ml or 200 IU/ml, then HBV-DNA ≥ the lower limit of detection);
- Creatine kinase (CK) more than 3 times the ULN;
- Thyroid-stimulating hormone (TSH) below the lower limit of normal (LLN) or more than 1.5 times the ULN;
- Other Conditions
- History of drug or alcohol abuse or dependence within the past 1 year;
- Pregnant or breastfeeding women;
- Participants in any drug or medical device clinical trial within 3 months prior to screening (defined by the participant receiving the trial drug/device treatment), or within 5 half-lives of the trial drug prior to screening, whichever is longer;
- Participants deemed by the investigator to have poor compliance or any factors that make them unsuitable for this trial, including but not limited to participation posing unacceptable risk to the participant or potentially interfering with study results.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Oral HRS-5346 in Adult Patients at High Risk of Cardiovascular Events With Elevated Lipoprotein(a)
The main purpose of this study is to evaluate the efficacy and safety of HRS-5346 in adult participants with elevated Lp(a) at high risk for cardiovascular events.
- Conditions
- Treatment of Lipoprotein Disorder
- Being tested
- HRS-5346, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-5346Drug
HRS-5346
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| HRS-5346 Dose 1 | Experimental | Not described Receives: Drug: HRS-5346 |
| HRS-5346 Dose 2 | Experimental | Not described Receives: Drug: HRS-5346 |
| HRS-5346 Dose 3 | Experimental | Not described Receives: Drug: HRS-5346 |
| 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.
Percent Change from Baseline in Lipoprotein (a) Lp(a)
Measured: Baseline to Week 12
Secondary outcomes (4)
The percentage of all reported adverse events, serious adverse events and treatment-related adverse events, serious adverse events.
Measured: From Day 1 to Week 16
Percentage of Participants Achieving Lp(a) <125 Nanomole/Liter (nmol/L)
Measured: Week 12
Percentage of Participants Achieving Lp(a) <75 Nanomole/Liter (nmol/L)
Measured: Week 12
The plasma concentration of HRS-5346.
Measured: From Day 1 to Week 16
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 start18 Feb 2025
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Lipoprotein DisorderStudies 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
- 120 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
- NCT06816264
- Sponsor's protocol ID
- HRS-5346-201
- Status last verified
- Oct 2025
- First submitted
- 4 Feb 2025
- Last updated
- 17 Nov 2025
- 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Oral HRS-5346 in Adult Patients at High Risk of Cardiovascular Events With Elevated Lipoprotein(a)
- ClinicalTrials.gov ID
- NCT06816264
- Acronym / sponsor ID
- HRS-5346-201
- Conditions
- Treatment of Lipoprotein Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 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.
The main purpose of this study is to evaluate the efficacy and safety of HRS-5346 in adult participants with elevated Lp(a) at high risk for cardiovascular events.
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-5346 Dose 1 | Experimental | Drug: HRS-5346 |
| HRS-5346 Dose 2 | Experimental | Drug: HRS-5346 |
| HRS-5346 Dose 3 | Experimental | Drug: HRS-5346 |
| 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 (6 listed)
- Understanding the specific procedures of the trial, voluntarily participating in this trial, and providing written informed consent;
- Being at least 18 years of age on the day of signing the informed consent form;
- Body Mass Index (BMI) within the range of 18.5 to 40 kg/m² (inclusive of boundary values);
- Participants must be at high risk of cardiovascular events, defined as individuals diagnosed with Atherosclerotic Cardiovascular Disease (ASCVD) and those at high risk for ASCVD.
- Participants (including their partners) are willing to voluntarily use highly effective contraceptive measures from the time of signing the informed consent form until 6 months after the last administration of the study drug; female participants must have a negative blood pregnancy test and must not be breastfeeding;
Key exclusion criteria (28 listed)
- Medical History and Concomitant Medications
- Occurrence of any of the following events within 3 months prior to screening, or between screening and randomization, or any other event deemed by the investigator to indicate clinical instability: major cardiac or non-cardiac surgery, coronary, carotid, or peripheral artery revascularization, stroke or transient ischemic attack, myocardial infarction or unstable angina, acute limb ischemia;
- Planned or anticipated cardiac, cerebrovascular, or peripheral artery surgery or coronary revascularization or other major surgery after randomization;
- History of hemorrhagic stroke or other significant bleeding events;
- History of malignancy in any organ system (except well-treated basal cell carcinoma of the skin);
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-5346HRS-5346 | Drug | HRS-5346 Dose 1, HRS-5346 Dose 2, HRS-5346 Dose 3 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Percent Change from Baseline in Lipoprotein (a) Lp(a)
Time frame: Baseline to Week 12
4 secondary outcomes
The percentage of all reported adverse events, serious adverse events and treatment-related adverse events, serious adverse events.
Time frame: From Day 1 to Week 16
Percentage of Participants Achieving Lp(a) <125 Nanomole/Liter (nmol/L)
Time frame: Week 12
Percentage of Participants Achieving Lp(a) <75 Nanomole/Liter (nmol/L)
Time frame: Week 12
The plasma concentration of HRS-5346.
Time frame: From Day 1 to Week 16
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 17 Nov 2025.
- 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-5346 in people with Treatment of Lipoprotein Disorder, 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 6 inclusion and 28 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 17 Nov 2025. 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?
Percent Change from Baseline in Lipoprotein (a) Lp(a) (time frame: Baseline to 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 17 Nov 2025.