A Study in Patients With Mixed Dyslipidemia

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Mixed Dyslipidemia

In brief

A Phase 2 in Patients With Mixed Dyslipidemia

Key facts

Study ID

NCT06497127

Run by

Shanghai Argo Biopharmaceutical Co., Ltd.

People needed

145

Starts

2024-02-28

Expected to finish

2028-03-30

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have given written informed consent and be able to comply with all study requirements.
• Males or females aged 18 to 75 aged years, inclusive, at the time of informed consent
• Fasting LDL-C ≥ 70 mg/dL [1.8 mmol/L] at Screening.
• 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.
• 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.
• 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

You may not qualify if…

• Active pancreatitis within 12 weeks prior to Day 1.
• Clinically significant acute cardiovascular even or procedure
• 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.
• 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.
• 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.

Where it is running

• Alliance for Multispecialty Research, LLC — Daphne, Alabama, United States
• Alliance for Multispecialty Research, LLC — Mobile, Alabama, United States
• Excel Medical Clinical Trials, LLC, dba Flourish Research — Boca Raton, Florida, United States
• East Coast Institute for Research, LLC — Jacksonville, Florida, United States
• Clinical Site Partners Leesburg, LLC dba Flourish Research — Leesburg, Florida, United States
• Suncoast Research Group, LLC DBA Flourish Research — Miami, Florida, United States
• Clinical Site Partners, LLC DBA Flourish Research — Miami, Florida, United States
• East Coast Institute for Research LLC — Canton, Georgia, United States
• Alliance for Multispecialty Research, LLC — Oak Brook, Illinois, United States
• Alliance for Multispecialty Research, LLC — Park Ridge, Illinois, United States
• Alliance for Multispecialty Research, LLC — Newton, Kansas, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Alliance for Multispecialty Research, LLC — Norman, Oklahoma, United States
• Clinical Trials of Texas, LLC — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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