Clinical Trials in the USA / NCT06497127
Active, not recruiting
Phase 2
A Study in Patients With Mixed Dyslipidemia
NCT06497127 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Mixed Dyslipidemia
Investigational drug(s) / intervention(s)
BW-00112
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
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 |
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Official registry record
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.
View NCT06497127 on ClinicalTrials.gov ↗ ← All trials in the USA