A Study of HRS-5632 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events

NCT07185776 | Active Not Recruiting Phase 2

• 1 other identifier: HRS-5632-201
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 2

Brief Summary

The main purpose of this study is to evaluate the efficacy and safety of HRS-5632 in adult participants with elevated Lipoprotein(a) (Lp(a)) at high risk for cardiovascular events.

Conditions

Lipoprotein Disorder

Outcome Measures

Primary Outcomes (1)

• The percent change from the baseline in Lipoprotein (a) (Lp(a)).

  From baseline to Day 360.

Secondary Outcomes (7)

• The percentage of all reported adverse events (AEs).

  From Day 1 to Day 540.

• The percentage of all reported serious adverse events (SAEs).

  From Day 1 to Day 540.

• The percentage of treatment-related adverse events.

  From Day 1 to Day 540.

• The percentage of treatment-related serious adverse events.

  From Day 1 to Day 540.

• The percentage of participants achieving Lipoprotein(a) (Lp(a)) < 125 Nanomole/Liter (nmol/L).

  Day 540.

Study Arms (5)

HRS-5632 Dose 1 Group

EXPERIMENTAL

Drug: HRS-5632 Injection

HRS-5632 Dose 2 Group

EXPERIMENTAL

Drug: HRS-5632 Injection

HRS-5632 Dose 3 Group

EXPERIMENTAL

Drug: HRS-5632 Injection

HRS-5632 Dose 4 Group

EXPERIMENTAL

Drug: HRS-5632 Injection

HRS-5632 Placebo Group

PLACEBO COMPARATOR

Drug: HRS-5632 Injection Placebo

Interventions

HRS-5632 Injection DRUG

HRS-5632 injection.

HRS-5632 Dose 1 Group; HRS-5632 Dose 2 Group; HRS-5632 Dose 3 Group; HRS-5632 Dose 4 Group

HRS-5632 Injection Placebo DRUG

HRS-5632 injection placebo.

HRS-5632 Placebo Group

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 moderate risk or high risk for ASCVD；
• Based on clinical practice, participants receiving the following medications must be receiving a stable regimen prior to screening or randomization and expected to remain on a stable regimen at the end of the treatment follow-up period:
• Lipid-lowering drugs (statins, cholesterol absorption inhibitors, prescription-dose niacin, fibrates, fish oil or other omega-3 fatty acid-containing products, including over-the-counter \[OTC\] preparations) must be receiving a stable regimen for ≥ 8 weeks prior to randomization; PCSK9 monoclonal antibodies must be receiving a stable regimen for ≥ 12 weeks prior to screening;
• Testosterone, estrogen, anti-estrogen/anti-androgen, progestin, selective estrogen receptor modulator, or growth hormone must be receiving a stable regimen for ≥ 4 weeks prior to screening;
• Participants (including their partners) are willing to voluntarily use highly effective contraceptive measures from the time of signing the informed consent form until 1 year 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:

• Any of the following events occurring within 3 months prior to screening or between screening and randomization, or other events considered by the investigator to indicate clinical instability: major cardiac or non-cardiac surgery; coronary, carotid, or peripheral arterial revascularization; stroke or transient ischemic attack, myocardial infarction or unstable angina, acute limb ischemia, and uncontrolled arrhythmias requiring treatment;
• Cardiac, cerebrovascular, or peripheral arterial surgery or coronary revascularization planned or anticipated during the trial after randomization;
• A history of hemorrhagic stroke or other major bleeding (e.g., hemophilia, von Willebrand disease, coagulation factor deficiency), or a hemorrhagic stroke or other major bleeding event (fatal; major organ bleeding; resulting in a rapid, short-term decrease in hemoglobin or blood transfusion) occurring between the screening visit and the randomization visit;
• Patients with an indication for anticoagulation at screening but not receiving anticoagulation therapy, such as patients with atrial fibrillation or flutter or those undergoing aortic valve replacement;
• History of any organ system malignancy within 5 years prior to screening (excluding cured basal cell or squamous cell skin cancer, non-invasive stage 0 cervical cancer, non-invasive stage 0 prostate cancer, or ductal carcinoma in situ of the breast), or a history of any organ system malignancy diagnosed between the screening visit and the randomization visit, regardless of whether there is evidence of local recurrence or metastasis;
• A history of a disease that significantly affects lipid levels, such as nephrotic syndrome, severe liver disease, or Cushing's syndrome;
• Uncontrolled type 1 or type 2 diabetes (including diabetic ketoacidosis or hyperglycemic hyperosmolar state) within 6 months prior to screening, or HbA1c \> 8.0% at screening (secondary confirmation is permitted);
• History of acute kidney injury within 12 months prior to screening;
• Uncontrolled hyperthyroidism or hypothyroidism at screening or before randomization;
• Active infection requiring systemic antiviral or antibacterial medication before randomization;
• New York Heart Association (NYHA) class III-IV heart function or a most recently measured left ventricular ejection fraction (LVEF) \<30% at screening or before randomization;
• At screening or before randomization, patients, as determined by the investigator, have a major medical condition that is currently unstable and not adequately controlled, such as hematologic disease, renal disease, metabolic or endocrine dysfunction, gastrointestinal disease, chronic disease or infection, unstable mental health disorder, or are recovering from major surgery;
• 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 within 3 months prior to screening, or plans to undergo such treatment during the study;
• Patients who are allergic to the active ingredient or any excipients of HRS-5632;

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (2)

The Second Affiliated Hospital of AFMU

Xi’an, Shanxi, 710038, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, 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: September 15, 2025
• First Posted: September 22, 2025
• Study Start: October 21, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

CN (2)