2025-521912-21-00招募中2 期
A multi- center, randomized, double-blind, placebo-controlled parallel–group, dose-finding study to evaluate efficacy, safety, and tolerability of DII235 in adults with elevated Lipoprotein(a)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 19
- 主要终点
- Time averaged percent change from baseline in Lp(a) measured between Day 60 and Day 180
研究概览
简要总结
- To evaluate the dose-response relationship of DII235 administered as compared to placebo on time averaged percentage change from baseline of Lp(a) in adults with elevated Lp(a) (defined as Lp(a) ≥ 150 nmol/L).
- To evaluate the efficacy of DII235 versus placebo in time averaged percent change from baseline in Lp(a) between Day 60 and Day 360.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent must be obtained prior to participation in the study.
- •Male or female participants 18 to 80 years of age (inclusive) at the screening.
- •Lp(a) ≥ 150 nmol/L at screening, measured at the central laboratory.
- •Presence of ASCVD and/or Type 2 diabetes mellitus (T2DM). Diagnosis of ASCVD should be based on at least one of the following: a. Coronary heart disease (CHD): • Prior myocardial infarction (MI) of presumed atherosclerotic origin, which occurred ≥ 12 weeks prior to the Screening Visit • Prior coronary revascularization (PCI or CABG) that occurred ≥ 12 weeks prior to the Screening Visit • Angiographic or CT-imaging (e.g., MDCT/CTA) evidence of coronary atherosclerosis: ≥50% stenosis in at least one major epicardial coronary artery • Coronary artery calcium (CAC) score of ≥ 300 AU by computed tomography (if a participant has T2DM CAC score of ≥ 100 AU is sufficient to define ASCVD) And/or b. Cerebrovascular disease (CVD): • Prior ischemic stroke, which occurred ≥ 12 weeks prior to the Screening Visit, confirmed by documented brain imaging (CT or MRI); embolic stroke (not of atherosclerotic origin) is not a qualifying event. • History of percutaneous or surgical carotid artery revascularization that occurred ≥ 12 weeks prior to the Screening Visit • Carotid artery stenosis ≥ 70% or symptomatic carotid artery disease with ≥ 50% carotid arterial stenosis on prior angiography or ultrasound And/or c. Peripheral arterial disease (PAD): • Prior non-traumatic amputation of a lower extremity due to peripheral artery disease • History of prior percutaneous or surgical revascularization of iliac, femoral, or popliteal artery • Prior documentation of a resting ankle-brachial index ≤ 0.9 On standard of care treatment for ASCVD risk factors (according to local guidelines and per Investigator discretion). Participants receiving lipid lowering therapy (including statins, ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibody inhibitors must be on a stable regimen per local guidelines for a minimum of 4 weeks prior to screening, with no planned changes made after screening, and expected to remain on a stable regimen through the end of the treatment (as statins may raise Lp(a) concentrations).
排除标准
- •Acute cardiovascular event (e.g., acute myocardial infarction or unstable angina, CABG, stroke, TIA) within 12 weeks before screening
- •Renal dysfunction with eGFR rate < 30 mL/min/1.73 m2 (using CKD-EPI formula) at screening
- •Positive human immunodeficiency virus (HIV), hepatitis C, or hepatitis B surface antigen tests from central laboratory at Screening Visit.
- •Hepatic dysfunction based on liver function tests at screening (defined as AST or ALT > 2 × ULN or total bilirubin > 1.5 × ULN at screening) (participants with Gilbert’s syndrome are allowed if total bilirubin < 2 × ULN)
- •Current or prior history of moderate to severe heart failure of NYHA Class III or IV, or known LVEF < 30% at screening
- •Uncontrolled cardiac arrhythmia
结局指标
主要结局
Time averaged percent change from baseline in Lp(a) measured between Day 60 and Day 180
Time averaged percent change from baseline in Lp(a) measured between Day 60 and Day 180
Time averaged percent change from baseline in Lp(a) measured between Day 60 and Day 360
Time averaged percent change from baseline in Lp(a) measured between Day 60 and Day 360
次要结局
- Time averaged percent change from baseline in Lp(a) measured (i) between Day 60 and Day 360; and (ii) between Day 240 and Day 360
- Participant's status of achieving Lp(a) < 125 nmol/L at Day 180 and Day 360 (Yes, No)
- Participant's status of achieving Lp(a) < 75 nmol/L at Day 180 and Day 360
- Incidence of Adverse events, safety laboratory parameters, and vital signs
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (19)
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