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

NCT07767513 | Not Yet Recruiting Phase 2

• 1 other identifier: HRS-5346-202
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Lipoprotein Disorder

Outcome Measures

Primary Outcomes (1)

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

  Week 12

Secondary Outcomes (9)

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

  Week 4

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

  Week4, Week 12

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

  Week4, Week 12

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

  Week4, Week 12

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

  Week4, Week 12

Study Arms (2)

Treatment group A: HRS-5346 Dose1

EXPERIMENTAL

Drug: HRS-5346

Treatment group B: HRS-5346 Dose2

EXPERIMENTAL

Drug: HRS-5346

Interventions

HRS-5346 DRUG

HRS-5346; Dose1

Treatment group A: HRS-5346 Dose1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.;
• 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;

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Central Study Contacts

Na Li

CONTACT

+8615811068575; na.li.nl80@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 17, 2026

Record last verified: 2026-08

Locations

CN (1)