Status:
RECRUITING
A Study in Patients With Mixed Dyslipidemia
Lead Sponsor:
Shanghai Argo Biopharmaceutical Co., Ltd.
Conditions:
Mixed Dyslipidemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
A Phase 2 in Patients With Mixed Dyslipidemia
Detailed Description
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Subcutaneously Administered BW-00112 in Patients with Mixed Dyslipidemia
Eligibility Criteria
Inclusion
- Must have given written informed consent and be able to comply with all study requirements.
- Males or females aged 18 to 75 aged years, inclusive, at the time of informed consent
- Fasting LDL-C ≥ 70 mg/dL \[1.8 mmol/L\] at Screening.
- 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.
- 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.
- 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
- 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 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.
- 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.
- 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.
Key Trial Info
Start Date :
February 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2028
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06497127
Start Date
February 28 2024
End Date
March 30 2028
Last Update
November 25 2025
Active Locations (14)
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1
Alliance for Multispecialty Research, LLC
Daphne, Alabama, United States, 36526
2
Alliance for Multispecialty Research, LLC
Mobile, Alabama, United States, 36608
3
Excel Medical Clinical Trials, LLC, dba Flourish Research
Boca Raton, Florida, United States, 33434
4
East Coast Institute for Research, LLC
Jacksonville, Florida, United States, 32204