New shot aims to tame high cholesterol and triglycerides
NCT ID NCT06497127
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an investigational drug called BW-00112 in 145 adults with mixed dyslipidemia, a condition where levels of certain blood fats are too high. Participants receive injections of the drug or a placebo over several months while continuing their usual statin medication. The main goal is to see if BW-00112 safely reduces triglycerides and other fats in the blood.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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145 people
The number who actually took part.
- Started
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Feb 2024
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Alliance for Multispecialty Research, LLC
Daphne, Alabama, 36526, United States
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Alliance for Multispecialty Research, LLC
Mobile, Alabama, 36608, United States
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Alliance for Multispecialty Research, LLC
Oak Brook, Illinois, 60523, United States
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Alliance for Multispecialty Research, LLC
Park Ridge, Illinois, 60068, United States
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Alliance for Multispecialty Research, LLC
Newton, Kansas, 67114, United States
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Alliance for Multispecialty Research, LLC
Norman, Oklahoma, 73069, United States
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Clinical Site Partners Leesburg, LLC dba Flourish Research
Leesburg, Florida, 34748, United States
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Clinical Site Partners, LLC DBA Flourish Research
Miami, Florida, 33186, United States
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Clinical Trials of Texas, LLC
San Antonio, Texas, 78229, United States
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East Coast Institute for Research LLC
Canton, Georgia, 30114, United States
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East Coast Institute for Research, LLC
Jacksonville, Florida, 32204, United States
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Excel Medical Clinical Trials, LLC, dba Flourish Research
Boca Raton, Florida, 33434, United States
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029-6574, United States
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Suncoast Research Group, LLC DBA Flourish Research
Miami, Florida, 33135, United States
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