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

Not Applicable

Recruiting

• Conditions: Hyperlipidemia
• Interventions: Drug: HRS-7249 Injection; Drug: Sodium Chloride Injection

• Registration Number: NCT07100418
• Lead Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-27
• Study First Submitted QC: 2025-07-27
• Study First Posted: 2025-08-03
• Study Start: 2025-08-12
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-09
• Last Update Posted: 2025-09-10
• Primary Completion: 2026-09
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HRS-7249 Group	HRS-7249 Injection	-
Sodium Chloride Injection Group	Sodium Chloride Injection	-

Primary Outcome Measures

Name	Time	Method
The level of triglyceride (TG)	About 28 weeks.

Secondary Outcome Measures

Name	Time	Method
Adverse events (AEs)	About 48 weeks.

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai Municipality, China