Phase
Condition
N/ATreatment
BW-00112
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must have given written informed consent and be able to comply with all studyrequirements.
Males or females aged 18 to 75 aged years, inclusive, at the time of informedconsent
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
Exclusion Criteria:
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 diabeticketoacidosis, diabetic decompensation, hyperosmolar hyperglycemic nonketotic coma,diabetes complications, recurrent infections, or hospitalization related to poorglycemic control within 24 weeks prior to Day 1.
Presence of any clinically significant uncontrolled disease known to influence serumlipids or lipoproteins. NOTE: Patients on thyroid replacement therapy are eligibleif 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 othercholesterol lowering medication 30 days prior to Day 1, other than statins andezetimibe.
Study Design
Study Description
Connect with a study center
Alliance for Multispecialty Research, LLC
Daphne, Alabama 36526
United StatesSite Not Available
Alliance for Multispecialty Research, LLC
Mobile, Alabama 36608
United StatesSite Not Available
Alliance for Multispecialty Research, LLC
Daphne 4058219, Alabama 4829764 36526
United StatesSite Not Available
Alliance for Multispecialty Research, LLC
Mobile 4076598, Alabama 4829764 36608
United StatesSite Not Available
Excel Medical Clinical Trials, LLC, dba Flourish Research
Boca Raton, Florida 33434
United StatesSite Not Available
East Coast Institute for Research, LLC
Jacksonville, Florida 32204
United StatesSite Not Available
Clinical Site Partners Leesburg, LLC dba Flourish Research
Leesburg, Florida 34748
United StatesSite Not Available
Clinical Site Partners, LLC DBA Flourish Research
Miami, Florida 33186
United StatesSite Not Available
Suncoast Research Group, LLC DBA Flourish Research
Miami, Florida 33135
United StatesActive - Recruiting
Excel Medical Clinical Trials, LLC, dba Flourish Research
Boca Raton 4148411, Florida 4155751 33434
United StatesSite Not Available
East Coast Institute for Research, LLC
Jacksonville 4160021, Florida 4155751 32204
United StatesSite Not Available
Clinical Site Partners Leesburg, LLC dba Flourish Research
Leesburg 4161771, Florida 4155751 34748
United StatesSite Not Available
Clinical Site Partners, LLC DBA Flourish Research
Miami 4164138, Florida 4155751 33186
United StatesSite Not Available
Suncoast Research Group, LLC DBA Flourish Research
Miami 4164138, Florida 4155751 33135
United StatesSite Not Available
East Coast Institute for Research LLC
Canton, Georgia 30114
United StatesSite Not Available
East Coast Institute for Research LLC
Canton 4186213, Georgia 4197000 30114
United StatesSite Not Available
Alliance for Multispecialty Research, LLC
Oak Brook, Illinois 60523
United StatesSite Not Available
Alliance for Multispecialty Research, LLC
Park Ridge, Illinois 60068
United StatesSite Not Available
Alliance for Multispecialty Research, LLC
Oak Brook 4904277, Illinois 4896861 60523
United StatesSite Not Available
Alliance for Multispecialty Research, LLC
Park Ridge 4905367, Illinois 4896861 60068
United StatesSite Not Available
Alliance for Multispecialty Research, LLC
Newton, Kansas 67114
United StatesSite Not Available
Alliance for Multispecialty Research, LLC
Newton 4276248, Kansas 4273857 67114
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029-6574
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029-6574
United StatesSite Not Available
Alliance for Multispecialty Research, LLC
Norman, Oklahoma 73069
United StatesSite Not Available
Alliance for Multispecialty Research, LLC
Norman 4543762, Oklahoma 4544379 73069
United StatesSite Not Available
Clinical Trials of Texas, LLC
San Antonio, Texas 78229
United StatesSite Not Available
Clinical Trials of Texas, LLC
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available

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