HRS-7249 injections for treating hyperlipidemia.

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

This trial will test whether injections of HRS-7249 can safely lower lipid levels in adults with hyperlipidemia.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. (industry)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07100418 on ClinicalTrials.gov

What this trial studies

This phase 2 interventional study gives adults with hyperlipidemia injections of HRS-7249 and uses sodium chloride injections as the comparator while testing different dose levels to identify a reasonable dose. Participants will be monitored over a defined treatment period for changes in lipid measurements and for any adverse effects. Safety labs and clinical assessments will be used to track tolerability and organ function. The goal is to find a dose that balances lipid-lowering effect with acceptable safety.

Who should consider this trial

Good fit: Adults aged 18 to 79 with hyperlipidemia who can give informed consent and do not have unstable or severe comorbid conditions are the intended candidates.

Not a fit: People with recent acute pancreatitis, recent or active cancer, severe cardiovascular or cerebrovascular disease, uncontrolled diabetes or hypertension, significant liver/kidney or blood abnormalities, pregnancy, or other excluded conditions are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, HRS-7249 could provide an additional option to lower cholesterol and reduce cardiovascular risk with an optimized dosing regimen.

How similar studies have performed: Other injectable lipid-lowering therapies such as PCSK9 inhibitors have been successful, but HRS-7249 itself is a new agent that has not yet been proven in large clinical trials.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Chanjuan Deng

Conditions: Hyperlipidemia