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
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2025
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2025
CompletedFirst Posted
Study publicly available on registry
August 3, 2025
CompletedStudy Start
First participant enrolled
August 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
September 10, 2025
September 1, 2025
1.1 years
July 27, 2025
September 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The level of triglyceride (TG)
About 28 weeks.
Secondary Outcomes (1)
Adverse events (AEs)
About 48 weeks.
Study Arms (2)
HRS-7249 Group
EXPERIMENTALSodium Chloride Injection Group
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Able and willing to provide a written informed consent.
- Age ≥ 18 years old and \< 80 years old.
- Male or female.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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
July 27, 2025
First Posted
August 3, 2025
Study Start
August 12, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
January 1, 2027
Last Updated
September 10, 2025
Record last verified: 2025-09