Mixed Dyslipidemia
Conditions
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
Interventions
DRUGBW-00112
BW-00112 or volume-matched placebo on Day 1 and Day 90
Sponsors
Shanghai Argo Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in fasting TG | From baseline to Day 180 | Percent change in fasting TG from baseline to Day 180 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in fasting TG | From baseline to Day 15, 30, 60, 90, 135, 225, and 270 | Percent change in fasting TG from baseline to Day 15, 30, 60, 90, 135, 225, and 270 |
Countries
United States
Outcome results
None listed