RecruitingPhase 2NCT07100418

A Clinical Study Evaluating the Efficacy and Safety of HRS-7249 in Treating Patients With Hyperlipidemia

A Multicenter, Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of HRS-7249 in Patients With Hyperlipidemia


Sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Enrollment

200 participants

Start Date

Aug 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study is being conducted to evaluate the efficacy and safety of HRS-7249 for patients with hyperlipidemia, and to explore the reasonable dosage of HRS-7249 for patients with hyperlipidemia.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

  • Able and willing to provide a written informed consent.
  • Age ≥ 18 years old and < 80 years old.
  • Male or female.

Exclusion Criteria16

  • Acute pancreatitis within 3 months or within 4 weeks or planned for plasma exchange treatment.
  • Malignant tumors within 5 years.
  • Severe cardiovascular or cerebrovascular diseases.
  • Severe trauma or surgery within 6 months or severe infection within 3 months.
  • Previous diagnosed diseases affecting lipid levels.
  • Patients with unstable or severe diseases assessed as at risk by the investigator.
  • Uncontrolled hypertension.
  • Weight loss within 2 months or planned surgery causing unstable weight.
  • Uncontrolled diabetes.
  • Combined hyperthyroidism or hypothyroidism.
  • History of drug or alcohol abuse.
  • Significantly abnormal liver or kidney function.
  • Significantly abnormal blood routine.
  • Significantly abnormal thyroid function.
  • Participated in clinical research within 3 months.
  • Pregnant or lactating women, or refusing contraception.

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Interventions

DRUGHRS-7249 Injection

HRS-7249 injection.

DRUGSodium Chloride Injection

Sodium chloride injection.


Locations(1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

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NCT07100418


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