Hyperlipidemia
Conditions
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.
Interventions
HRS-7249 injection.
Sodium chloride injection.
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The level of triglyceride (TG) | About 28 weeks. |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AEs) | About 48 weeks. |
Countries
China
Contacts
Primary ContactChanjuan Deng
Outcome results
None listed