NCT06497127进行中（未招募）2 期
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
Shanghai Argo Biopharmaceutical Co., Ltd.14 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2024年2月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 145
- 试验地点
- 14
- 主要终点
- Percent change in fasting TG
研究概览
简要总结
A Phase 2 in Patients With Mixed Dyslipidemia
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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
排除标准
- •Active pancreatitis within 12 weeks prior to Day
- •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
- •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
- •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.
研究组 & 干预措施
Cohort 1
Experimental
BW-00112 150 mg or volume-matched placebo on Day 1 and Day 90
干预措施: BW-00112 (Drug)
Cohort 2
Experimental
BW-00112 300 mg or volume-matched placebo on Day 1 and Day 90
干预措施: BW-00112 (Drug)
Cohort 3
Experimental
BW-00112 600 mg or volume-matched placebo on Day 1 and Day 90
干预措施: BW-00112 (Drug)
结局指标
主要结局
Percent change in fasting TG
时间窗: From baseline to Day 180
Percent change in fasting TG from baseline to Day 180
次要结局
- Percent change in fasting TG(From baseline to Day 15, 30, 60, 90, 135, 225, and 270)
研究者
研究点 (14)
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