NCT07219602进行中（未招募）3 期
A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib 10 mg and Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome (RUBENS Trial)
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 75
- 主要终点
- The percent change from Baseline to Day 84 in LDL-C compared with placebo for the following treatment groups: - obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group; and - obicetrapib 10 mg monotherapy treatment group
研究概览
简要总结
This study will be a placebo-controlled, double-blind, randomized, Phase 3 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both as a fixed-dose combination (FDC) with ezetimibe 10 mg and as monotherapy, on top of guideline-recommended lipid-lowering therapy in patients with metabolic syndrome and/or Type 2 Diabetes Mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •fasting serum LDL-C ≥ 70 mg/dL (≥1.81 mmol/L)
- •Have fasting TG ≥150 mg/dL (≥1.7 mmol/L) and <400 mg/dL (<4.5 mmol/L)
- •Know diagnosis of T2DM OR have metabolic syndrome defined as fasting TG ≥150 mg/dL (≥1.7mmol/L) and <400 mg/dL (<4.5 mmol/L) and at least 2 risk factors
- •Are on stable guideline-recommended lipid-lowering therapy
- •Estimated glomerular filtration rate ≥15 mL/min/1.73 m2
排除标准
- •Have current or any previous history of New York Heart Association class III or IV heart failure or left ventricular ejection fraction <30%
- •Have been hospitalized for heart failure within 5 years prior to Screening
- •Have uncontrolled severe hypertension
- •Have a formal diagnosis of homozygous familial hypercholesterolemia
- •HbA1c ≥10.0% (≥0.100 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening
- •active liver disease
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo on top of guideline-recommended lipid-lowering therapy
干预措施: Placebo (Other)
Obicetrapib
Experimental
obicetrapib 10 mg daily
干预措施: Obicetrapib 10 mg (Drug)
Open-Label Extension
Experimental
Open-Label Extension (OLE) with the FDC of Obicetrapib 10 mg and Ezetimibe 10 mg
干预措施: obicetrapib 10 mg + ezetimibe 10 mg FDC daily (Drug)
Obicetrapib/Ezetimibe
Experimental
obicetrapib 10 mg + ezetimibe 10 mg FDC daily
干预措施: obicetrapib 10 mg + ezetimibe 10 mg FDC daily (Drug)
结局指标
主要结局
The percent change from Baseline to Day 84 in LDL-C compared with placebo for the following treatment groups: - obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group; and - obicetrapib 10 mg monotherapy treatment group
时间窗: 84 days
次要结局
- Percent change from Baseline to Day 84 in non-HDL-C for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group(Day 84)
- Percent change from Baseline to Day 84 in HDL-C for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group(84 days)
- Percent change from Baseline to Day 84 in ApoB for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group(84 days)
- Percent change from Baseline to Day 84 in ApoA1 for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group(84 days)
- Percent change from Baseline to Day 84 in non-HDL-C for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group;(84 days)
- Percent change from Baseline to Day 84 in HDL-C for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group(Day 84)
- Percent change from Baseline to Day 84 in ApoB for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group(Day 84)
- Percent change from Baseline to Day 84 in ApoA1 for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group(Day 84)
- Percent change from Baseline to Day 84 in lipoprotein (a) (Lp[a]) for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group(Day 84)
- Percent change from Baseline to Day 84 in Lp(a) for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group(Day 84)
研究者
研究点 (75)
Loading locations...
相似试验
已完成
3 期
Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.DyslipidemiasHigh CholesterolMetabolic DiseaseLipid Metabolism, Inborn ErrorsGenetic Disease, InbornHyperlipoproteinemiasHypercholesterolemiaLipid Metabolism DisorderFamilial HypercholesterolemiaNCT05425745NewAmsterdam Pharma354
已完成
3 期
Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying TherapiesFamilial HypercholesterolemiaHypercholesterolemiaNCT05142722NewAmsterdam Pharma2,530
已完成
3 期
Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF EpisodesIdiopathic Parkinson's DiseaseNCT02240030Acorda Therapeutics351
进行中（未招募）
3 期
A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast CancerNCT04546009Hoffmann-La Roche992
终止
3 期
The INSPIRE Trial: A Study of Interferon Gamma-1b for Idiopathic Pulmonary Fibrosis (IPF)Lung DiseaseIdiopathic Pulmonary FibrosisPulmonary FibrosisNCT00075998InterMune826