BW-00112: BW-00112 or volume-matched placebo on Day 1 and Day 90
Study summary
A Phase 2 in Patients With Mixed Dyslipidemia
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Percent change in fasting TG — From baseline to Day 180 Percent change in fasting TG from baseline to Day 180
Trial sites (14)
Facility
City
Region
Status
Alliance for Multispecialty Research, LLC
Daphne
Alabama
Alliance for Multispecialty Research, LLC
Mobile
Alabama
Excel Medical Clinical Trials, LLC, dba Flourish Research
Boca Raton
Florida
East Coast Institute for Research, LLC
Jacksonville
Florida
Clinical Site Partners Leesburg, LLC dba Flourish Research
Leesburg
Florida
Suncoast Research Group, LLC DBA Flourish Research
Miami
Florida
Clinical Site Partners, LLC DBA Flourish Research
Miami
Florida
East Coast Institute for Research LLC
Canton
Georgia
Alliance for Multispecialty Research, LLC
Oak Brook
Illinois
Alliance for Multispecialty Research, LLC
Park Ridge
Illinois
Alliance for Multispecialty Research, LLC
Newton
Kansas
Icahn School of Medicine at Mount Sinai
New York
New York
Alliance for Multispecialty Research, LLC
Norman
Oklahoma
Clinical Trials of Texas, LLC
San Antonio
Texas
More Shanghai Argo Biopharmaceutical Co., Ltd. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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