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Lipoprotein DisorderPhase 2NCT07767513

Study of Oral HRS-5346 in Adult Patients With Elevated Lipoprotein(a) and High Risk of Cardiovascular Events

A Phase 2 study testing HRS-5346 in people with Lipoprotein Disorder, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is designed to evaluate the efficacy and safety of HRS-5346 Tablets in participants with high cardiovascular event risk and elevated Lp(a), and to investigate the appropriate dosage of HRS-5346 Tablets Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lipoprotein Disorder
What is being tested?
HRS-5346
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
Sep 2026to May 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

  • Understand the specific procedures of the trial, voluntarily participate in this trial, and provide written informed consent;
  • Aged ≥ 18 years on the day of signing the informed consent form;
  • Body mass index (BMI) ranging from 18.5 to 40 kg/m²;
  • High risk of cardiovascular events at screening;
  • Lp(a) ≥ 150 nmol/L as measured by the central laboratory during the screening period;
  • For participants receiving pharmacotherapy per clinical practice, they must have been on a stable treatment regimen for a specified duration prior to screening or randomization and are expected to remain on that regimen through the end of the treatment period;
  • Participants (including their partners) are willing to use effective contraception from the time of signing the informed consent form until 1 month after the last administration of the study drug; female participants must have a negative serum pregnancy test and must not be breastfeeding;
  • Willing and able to comply with all protocol requirements, including demonstrating adherence to study procedures prior to randomization.

Who cannot join

  • Any of the following occurring within 3 months prior to screening, or between screening and randomization: major cardiac or non-cardiac surgery, coronary, carotid or peripheral arterial revascularization, stroke or transient ischaemic attack, myocardial infarction or unstable angina, acute limb ischaemia; as well as arrhythmias requiring treatment but uncontrolled; or other events deemed clinically unstable by the Investigator;
  • Participants with planned or anticipated cardiac, cerebrovascular, or peripheral arterial surgery, coronary revascularization, or other major surgery during the trial period after randomization;
  • History of haemorrhagic stroke or other major bleeding, or occurrence of haemorrhagic stroke or other major bleeding events between screening visit and randomization visit;
  • Participants with an indication for anticoagulation but not receiving anticoagulant therapy at screening;
  • History of malignancy of any organ system within 5 years prior to screening, or newly diagnosed malignancy of any organ system between screening visit and randomization visit, regardless of signs of local recurrence or metastasis;
  • Prior 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, or HbA1c >8.0% at screening (a repeat confirmation is allowed);
  • History of acute kidney injury within 12 months prior to screening;
  • Uncontrolled hyperthyroidism or hypothyroidism at screening;
  • Active infection requiring systemic antiviral or antibacterial medication prior to randomization;
  • New York Heart Association (NYHA) functional class III-IV heart failure at screening, or the most recently measured left ventricular ejection fraction (LVEF) <30%;
  • At screening or prior to randomization, participants suffering from major diseases that are unstable and inadequately controlled, in the judgment of the Investigator;
  • Chronic, continuous, or repeated use of systemic glucocorticoids within 3 months prior to screening;
  • Receipt of lipoprotein apheresis within 3 months prior to screening, or planned lipoprotein apheresis during the study period;
  • Prior receipt of specific antisense or gene therapy;
  • Treatment with oligonucleotides or small interfering ribonucleic acid (siRNA) within 12 months prior to screening;
  • Use of weight-loss medications resulting in significant weight loss, or surgery leading to substantial weight loss within 3 months prior to screening;
  • Known hypersensitivity to the active ingredient or any excipient of HRS-5346;
  • Uncontrolled hypertension prior to randomization;
  • eGFR < 30 mL/min/1.73 m² at screening or prior to randomization, or participants receiving dialysis;
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma-glutamyl transferase (GGT) > 2 times the upper limit of normal (ULN), or total bilirubin >1.5 times ULN at screening or prior to randomization;
  • Human immunodeficiency virus infection (HIV-Ab positive), hepatitis C virus infection (HCV-RNA positive), Treponema pallidum infection (Treponema pallidum antibody positive), hepatitis B virus infection (HBsAg positive) at screening or prior to randomization;
  • Creatine kinase (CK) > 3 times the upper limit of normal (ULN) prior to randomization;
  • Thyroid-stimulating hormone (TSH) below the lower limit of normal (LLN) or above the upper limit of normal (ULN) during screening;
  • Significant abnormal laboratory parameters at screening or prior to randomization that render the participant unsuitable for this study, as judged by the Investigator;
  • History of drug or alcohol abuse or dependence in the recent past (within 1 year);
  • Pregnant or breastfeeding women;
  • Participation in any clinical trial of investigational drug or medical device within 3 months prior to screening, or still within 5 half-lives of the investigational product at screening, whichever is longer;
  • The Investigator judges that the participant has poor adherence or any other factor rendering participation inappropriate, including but not limited to circumstances where trial participation would expose the participant to unacceptable risk or may confound study results.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Na Li contact

+8615811068575

na.li.nl80@hengrui.com

China1 site

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Yucheng Chen

Other trials in China

About this study

Official title: A Randomized, Double-Blind Phase II Study to Evaluate the Efficacy and Safety of Oral HRS-5346 in Adult Patients With Elevated Lipoprotein(a) and High Risk of Cardiovascular Events

This study is designed to evaluate the efficacy and safety of HRS-5346 Tablets in participants with high cardiovascular event risk and elevated Lp(a), and to investigate the appropriate dosage of HRS-5346 Tablets

Being tested
HRS-5346

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HRS-5346Drug

    HRS-5346; Dose1

  • HRS-5346Drug

    HRS-5346; Dose2

Study groups in NCT07767513
Study groupRoleWhat they receive
Treatment group A: HRS-5346 Dose1ExperimentalNot described
Receives: Drug: HRS-5346
Treatment group B: HRS-5346 Dose2ExperimentalNot described
Receives: Drug: HRS-5346

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage Change in Lp(a) Levels from Baseline to Week 12

    Measured: Week 12

Secondary outcomes (9)

  1. Percentage change in Lp(a) levels from baseline to Week 4;

    Measured: Week 4

  2. Absolute change in Lp(a) levels from baseline to Week 4 and Week 12;

    Measured: Week4, Week 12

  3. Proportion of participants with greater than 70% reduction in Lp(a) levels from baseline at Week 4 and Week 12;

    Measured: Week4, Week 12

  4. Proportion of participants achieving Lp(a) < 125 nmol/L (i.e., 50 mg/dL) at Week 4 and Week 12;

    Measured: Week4, Week 12

  5. Proportion of participants achieving Lp(a) < 75 nmol/L (i.e., 30 mg/dL) at Week 4 and Week 12;

    Measured: Week4, Week 12

  6. Incidence and severity of any adverse event (AE);

    Measured: Week0- Week 13

  7. Incidence of adverse event of special interest (AESI)

    Measured: Week0- Week 13

  8. Incidence of serious adverse event (SAE)

    Measured: Week0- Week 13

  9. Pharmacokinetic assessment: plasma concentrations of HRS-5346.

    Measured: Week0- Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionFeb 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07767513
Sponsor's protocol ID
HRS-5346-202
Status last verified
Aug 2026
First submitted
12 Aug 2026
Last updated
17 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HRS-5346 in people with 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 8 inclusion and 29 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 17 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. 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 Na Li (+8615811068575, na.li.nl80@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change in Lp(a) Levels from Baseline to Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07767513.

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 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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