Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
145 participants
INTERVENTIONAL
2024-02-28
2028-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort 1
BW-00112 150 mg or volume-matched placebo on Day 1 and Day 90
BW-00112
BW-00112 or volume-matched placebo on Day 1 and Day 90
Cohort 2
BW-00112 300 mg or volume-matched placebo on Day 1 and Day 90
BW-00112
BW-00112 or volume-matched placebo on Day 1 and Day 90
Cohort 3
BW-00112 600 mg or volume-matched placebo on Day 1 and Day 90
BW-00112
BW-00112 or volume-matched placebo on Day 1 and Day 90
Interventions
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BW-00112
BW-00112 or volume-matched placebo on Day 1 and Day 90
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Argo Biopharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yuqiong Li, Master
Role: STUDY_DIRECTOR
Shanghai Argo Biopharmaceutical Co., Ltd.
Locations
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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
Countries
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Other Identifiers
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BW-00112-2002
Identifier Type: -
Identifier Source: org_study_id
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