A Study in Patients with Mixed Dyslipidemia

Launched by SHANGHAI ARGO BIOPHARMACEUTICAL CO., LTD. · Jul 4, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a condition called mixed dyslipidemia, which is when a person has unhealthy levels of cholesterol and fats in their blood. The study aims to test a new treatment to see how well it can help patients manage their cholesterol levels. The trial is currently recruiting participants who are between 18 and 75 years old and have specific cholesterol levels. To be eligible, participants must be on a stable cholesterol-lowering medication called a statin for at least one month before the study starts.

If you or a loved one are interested in participating, you will need to provide written consent and meet certain health criteria. Participants can expect regular check-ins and tests to monitor their health throughout the trial. It's also important to note that individuals with certain health issues, like recent heart problems or severe diabetes complications, may not be able to join. This study represents an opportunity to contribute to research that could lead to better treatments for mixed dyslipidemia, so it may be worth considering if you meet the eligibility requirements.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Must have given written informed consent and be able to comply with all study requirements.
• • 2. Males or females aged 18 to 75 aged years, inclusive, at the time of informed consent
• • 3. Fasting LDL-C ≥ 70 mg/dL \[1.8 mmol/L\] at Screening.
• • 4.150 mg/dL \[1.7 mmol/L\] ≤ fasting TG \< 500 mg/dL \[5.6 mmol/L\] at Screening, which may be repeated once if deemed necessary.
• • 5.On a stable statin for at least 1 month before Screening and plan to remain on the same medication and dose for the duration of the study.
• • 6.Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal 7.Male patients agreeing to use acceptable methods of contraception
• Exclusion Criteria:
• • 1. Active pancreatitis within 12 weeks prior to Day 1.
• • 2. Clinically significant acute cardiovascular even or procedure
• • 3. HbA1c \> 9.0% at Screening or patients with diabetes who have experienced diabetic ketoacidosis, diabetic decompensation, hyperosmolar hyperglycemic nonketotic coma, diabetes complications, recurrent infections, or hospitalization related to poor glycemic control within 24 weeks prior to Day 1.
• • 4. Presence of any clinically significant uncontrolled disease known to influence serum lipids or lipoproteins. NOTE: Patients on thyroid replacement therapy are eligible if the dosage of thyroxine has been stable for at least 12 weeks prior to Day 1.
• • 5. Use of TG lowering medication , non-prescription dietary supplements or other cholesterol lowering medication 30 days prior to Day 1, other than statins and ezetimibe.