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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hyperlipidemia
• Intervention / Treatment: Drug: HRS-7249 Injection; Drug: Sodium Chloride Injection

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200030
      • Shanghai Chest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-7249 Group	Drug: HRS-7249 Injection; HRS-7249 injection.
Placebo Comparator: Sodium Chloride Injection Group	Drug: Sodium Chloride Injection; Sodium chloride injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The level of triglyceride (TG)	About 28 weeks.

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events (AEs)	About 48 weeks.

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 27, 2025
• First Submitted That Met QC Criteria: July 27, 2025
• First Posted (Actual): August 3, 2025

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hyperlipidemias; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: HRS-7249-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No