NCT05256654已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3561774 in Adults With Mixed Dyslipidemia
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 41
- 主要终点
- Percent Change From Baseline for Apolipoprotein B (ApoB) at Day 180
研究概览
简要总结
This a multicenter, Phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy and safety of LY3561774 administered subcutaneously at various doses in participants with mixed dyslipidemia and on a stable dose of a statin.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have fasting triglycerides (TGs) within the range of 150 (1.69 millimole/liter (mmoL) to 499 milligram/deciliter (mg/dL) 2.26 to 5.64 millimole/liter (mmol/L) at screening.
- •Have fasting LDL-C ≥70 mg/dL (1.81 mmol/L) at screening.
- •Have non-HDL-C ≥ 130 mg/dL (3.36 mmol/L) at screening.
- •Must be on a stable moderate or high-intensity dose of a statin for at least 2 months before screening and remain on the same medication and dose for the duration of the study.
- •Have a body mass index within the range of 18.5 to 40.0 kilogram/square meter (kg/m²), inclusive
排除标准
- •Have in the 6 months prior to screening, uncontrolled Type 1 or Type 2 diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization, or have an hemoglobin A1c (HbA1c) ≥8% at screening.
- •Have a history of nephrotic syndrome.
- •Have a history of acute or chronic pancreatitis.
- •Have had within the past 3 months prior to screening
- •Myocardial infarction
- •Unstable angina
- •Coronary artery bypass graft
- •Percutaneous coronary intervention - diagnostic angiograms are permitted
- •Peripheral artery disease
- •Transient ischemic attack, or
- •Cerebrovascular accident
- •Have New York Heart Association Class III or IV heart failure or last known left ventricular ejection fraction <30%.
- •Have undergone LDL apheresis within 12 months prior to screening.
- •Have clinically relevant anemia, as defined by the investigator.
- •Have, within 1 year prior to screening or plan on having during the study, surgical treatment for obesity.
- •Have within 3 years prior to screening a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse.
- •Have uncontrolled hypertension.
- •Have used or are taking products for the purpose of lowering lipid levels (except for statins, PCSK9 inhibitors, bempedoic acid, and ezetimibe). This includes lipid-regulating medication, over-the-counter products, or herbal therapies.
研究组 & 干预措施
LY3561774 100 mg
Experimental
Participants received 100 milligram (mg) LY3561774 subcutaneously (SC) on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
干预措施: LY3561774 (Drug)
LY3561774 400 mg
Experimental
Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
干预措施: LY3561774 (Drug)
LY3561774 800 mg
Experimental
Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
干预措施: LY3561774 (Drug)
Placebo
Placebo Comparator
Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline for Apolipoprotein B (ApoB) at Day 180
时间窗: Baseline, Day 180
Change in apoB levels from baseline to Day 180 expressed as a percentage of the baseline levels. Least Square Mean (LS mean) using Mixed Model for Repeated Measures (MMRM) model adjusted for baseline.
次要结局
- Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3) at Day 180(Baseline, Day 180)
- Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) at Day 180(Baseline, Day 180)
- Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Day 180(Baseline, Day 180)
- Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Day 180(Baseline, Day 180)
- Percent Change From Baseline for Triglycerides at Day 180(Baseline, Day 180)
- Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3)(Baseline, Day 270)
- Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)(Baseline, Day 270)
- Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C)(Baseline, Day 270)
- Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C)(Baseline, Day 270)
- Percent Change From Baseline for Apolipoprotein B (ApoB)(Baseline, Day 270)
- Percent Change From Baseline for Triglycerides(Baseline, Day 270)
- Pharmacokinetics (PK): Seady State Area Under the Concentration Curve From Hour 0 Extrapolated to Infinity (AUC 0-∞) of LY3561774(On Day 0: 0.5 hour (hr) and at the latest time after 2 hr post-dose, Day 90: 24 to 48 hr postdose)
研究者
研究点 (41)
Loading locations...
相似试验
已完成
2 期
A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70)DyslipidemiasHyperlipidemiasHyperlipoproteinemiasNCT04516291Pfizer286
已完成
2 期
Safety, Tolerability and Activity Study of Ibudilast in Subjects With Progressive Multiple SclerosisMultiple Sclerosis, Primary ProgressiveMultiple Sclerosis, Secondary ProgressiveNCT01982942MediciNova255
终止
2 期
VTX958 for the Treatment of Moderately to Severely Active Crohn's DiseaseCrohn DiseaseNCT05688852Ventyx Biosciences, Inc107
进行中（未招募）
2 期
A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)NCT06643481Novartis Pharmaceuticals251
撤回
2 期
A Phase 2 Study of CX-8998 in Adults With Tremor Associated With Parkinson's DiseaseTremorParkinson's DiseaseNCT03436953Jazz Pharmaceuticals