A Study of HRS-5346 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events

NCT06816264 | Completed Phase 2

• 1 other identifier: HRS-5346-201
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Treatment of Lipoprotein Disorder

Outcome Measures

Primary Outcomes (1)

• Percent Change from Baseline in Lipoprotein (a) Lp(a)

  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.

  From Day 1 to Week 16

• Percentage of Participants Achieving Lp(a) <125 Nanomole/Liter (nmol/L)

  Week 12

• Percentage of Participants Achieving Lp(a) <75 Nanomole/Liter (nmol/L)

  Week 12

• The plasma concentration of HRS-5346.

  From Day 1 to Week 16

Study Arms (4)

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

Interventions

HRS-5346 DRUG

HRS-5346

HRS-5346 Dose 1; HRS-5346 Dose 2; HRS-5346 Dose 3

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• \- 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.;
• 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;

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China

Location

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: February 4, 2025
• First Posted: February 10, 2025
• Study Start: February 18, 2025
• Primary Completion: September 29, 2025
• Study Completion: September 29, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-10

Locations

CN (1)