NCT07450378尚未招募3 期
Evaluation of Efficacy and Safety of QLC7401 in Participants With Heterozygous Familial Hypercholesterolemia on a Stable Lipid-lowering Therapy: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Percent Change in LDL-C from Baseline
研究概览
简要总结
This Phase III clinical trial aims to assess the efficacy and safety of QLC7401 Treatment in adults with Heterozygous Familial Hypercholesterolemia on a stable lipid-lowering therapy. Participants will be randomly assigned to receive subcutaneous injections of either QLC7401 or a placebo according to the study schedule.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-80 years (inclusive)
- •Participants diagnosed with heterozygous familial hypercholesterolemia by Dutch Lipid Clinic
- •Network criteria or genetic testing;
- •Serum low density lipoprotein cholesterol ≥2.6 millimoles (mmol)/liter (L) at screening.
- •Fasting triglyceride <4.5 mmol/L at screening.
- •Participants on lipid-lowering therapies should be on a stable dose for ≥4 weeks before screening with no planned medication or dose change during study participation.
- •Estimated glomerular filtration Rate (eGFR) >30 mL/min/1.73 m².
- •Willing to provide informed consent.
排除标准
- •New York Heart Association (NYHA) class III or IV heart failure.
- •Uncontrolled cardiac arrhythmia.
- •Cardiovascular Diseases within 3 months.
- •Uncontrolled hypertension.
- •Poorly controlled type 2 diabetes.
- •Significant liver or kidney disease.
- •Pregnancy or lactation.
- •Other conditions deemed unsuitable by investigator.
研究组 & 干预措施
QLC7401 Injection
Experimental
干预措施: QLC7401 Injection (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change in LDL-C from Baseline
时间窗: From baseline to Day 360
次要结局
- Incidence of Treatment-Emergent Adverse Events(From baseline to Day 360)
研究者
相似试验
尚未招募
3 期
QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed DyslipidemiaNCT07444086Qilu Pharmaceutical Co., Ltd.510
尚未招募
1 期
First in Human Study of QLS5316 in Solid TumorsNCT07358884Qilu Pharmaceutical Co., Ltd.300
尚未招募
2 期
A Phase II Study of QLS12010 Capsules in Adults With Moderate to Severe Atopic DermatitisNCT07344051Qilu Pharmaceutical Co., Ltd.160
招募中
2 期
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic PainNCT07285018Eli Lilly and Company150
尚未招募
3 期
A Phase III Clinical Trial of NTQ1062 in Combination With Fulvestrant for the Treatment of Advanced or Metastatic HR+/HER2- Breast CancerNCT07393321Nanjing Chia-tai Tianqing Pharmaceutical210