2025-521936-12-00招募中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)
NewAmsterdam Pharma B.V.24 个研究点 分布在 3 个国家目标入组 118 人开始时间: 2026年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 118
- 试验地点
- 24
- 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
The primary objective of this study is to evaluate the effect of obicetrapib 10 mg + ezetimibe 10 mg FDC therapy and obicetrapib 10 mg monotherapy on LDL-C.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Are willing and able to give written informed consent before initiation of any study-related procedures and willing to comply with all required study procedures
- •Are male or female and ≥18 years of age at Screening (Visit 1); o Females may be enrolled if all 3 of the following criteria are met: They are not pregnant; They are not breastfeeding; and They do not plan on becoming pregnant during the study. o Female participants of childbearing potential and male participants whose partners are of childbearing potential must comply with the contraceptive requirements outlined in Appendix D.
- •Have a known diagnosis of type 2 diabetes mellitus based on the American Diabetes Association criteria (see Appendix C) for at least 6 months prior to Screening (Visit 1); OR Have metabolic syndrome, defined as: o Fasting TG ≥150 mg/dL (≥1.7 mmol/L) and <400 mg/dL (<4.5 mmol/L) at Screening (Visit 1) (Inclusion Criterion 5); and o 2 or more of the following: Fasting plasma glucose concentration ≥100 mg/dl (≥5.6 mmol/L) or HbA1c >5.7% or are receiving pharmacologic therapy for elevated fasting glucose levels; HDL-C <40 mg/dL (<1.0 mmol/L) for men; <50 mg/dL (<1.3 mmol/L) for women; Waist circumference ≥102 cm (men) or ≥88 cm (women) (≥90 cm [men] or ≥80 cm [women] for Asians and participants of Asian descent); Hypertension, defined as persistent elevated systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥85 mmHg, or are receiving pharmacologic therapy for hypertension; or Microalbuminuria, defined as a urine albumin-creatinine ratio ≥30 mg/g.
- •Have a fasting serum LDL-C at Screening (Visit 1) ≥70 mg/dL (≥1.8 mmol/L)
- •Have fasting TG ≥150 mg/dL (≥1.7 mmol/L) and <400 mg/dL (<4.5 mmol/L) at Screening (Visit 1)
- •Are on stable guideline-recommended lipid-lowering therapy, defined as at least one of the following therapies: o A statin for at least 8 weeks prior to Screening (Visit 1) o Bempedoic acid for at least 8 weeks prior to Screening (Visit 1); or o A PCSK9-targeted therapy alone or in combination with other lipid-modifying therapy for at least 4 doses prior to Screening (Visit 1).
- •Have an estimated glomerular filtration rate (eGFR) ≥15 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation at Screening (Visit 1).
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 a known history of alcohol and/or drug abuse within 5 years prior to Randomization (Visit 2 [Day 1]); as assessed by the Investigator
- •Have received treatment with other investigational products or devices within 30 days of Screening (Visit 1) or 5 half-lives of the previous investigational product, whichever is longer
- •Are taking gemfibrozil or have taken gemfibrozil within 30 days of Screening (Visit 1)
- •Are taking ezetimibe or have taken ezetimibe within 14 days of Screening (Visit 1)
- •Have had weight loss surgery (eg, sleeve gastrectomy, Roux-en-Y) within the last 12 months prior to Screening (Visit 1) or have plans for weight loss surgery during the study period
- •Are currently participating or have recently participated (within the 3 months prior to Randomization [Visit 2 (Day 1)]) in a weight loss program or are planning on participating in a medical or surgical weight loss program during the study
- •Have had a recent significant change in body weight, defined as a >5% change in body weight in the 3 months prior to Randomization (Visit 2 [Day 1])
- •Have planned use of other investigational products or devices during the course of the study
- •Have participated in any clinical study evaluating obicetrapib
- •Have a known allergy or hypersensitivity to the study drugs, placebo, or any of the excipients in the study drugs or placebo; or
- •Have been hospitalized for heart failure within 5 years prior to Screening (Visit 1)
- •Have any participant condition that, according to the Investigator, could interfere with the conduct of the study, such as, but not limited to, the following: o Are unable to communicate or to cooperate with the Investigator; o Are unable to understand the Protocol requirements, instructions and study-related restrictions, and the nature, scope, and possible consequences of the study (including participants whose cooperation is doubtful due to drug abuse or alcohol dependency); o Are unlikely to comply with the Protocol requirements, instructions, and study-related restrictions (eg, uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study); o Have any medical or surgical condition which, in the opinion of the Investigator, would put the participant at increased risk from participating in the study; or o Are directly involved in the conduct of the study
- •Have uncontrolled severe hypertension, defined as either systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at both Screening (Visit 1) and Randomization (Visit 2 [Day 1]) taken as the average of triplicate measurements
- •Have a formal diagnosis of homozygous familial hypercholesterolemia
- •Have active liver disease, defined as any known current infectious, neoplastic, or metabolic pathology of the liver, Child-Pugh score of 7 to 9 (Class B) or 10 to 15 (Class C);, unexplained elevations in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × upper limit of normal (ULN); or total bilirubin >2 × ULN at Screening (Visit 1)
- •Have an HbA1c ≥10.0%(≥0.100 hemoglobin fraction) at Screening (Visit 1)
- •Have thyroid-stimulating hormone >1.5 × ULN at Screening (Visit 1)
- •Have creatine kinase (CK) >5 × ULN at Screening (Visit 1)
- •Have a history of a malignancy that required surgery (excluding local and wide local excision), radiation therapy, and/or systemic therapy during the 3 years prior to Randomization (Visit 2 [Day 1])
研究组 & 干预措施
Obicetrapib 10 mg + ezetimibe 10 mg fixed dose combination (FDC)
Test
干预措施: Obicetrapib 10 mg + ezetimibe 10 mg fixed dose combination (FDC) (Drug)
Placebo matching Obicetrapib 10 mg tablets
Placebo
干预措施: Placebo matching Obicetrapib 10 mg tablets (Drug)
Placebo matching Obicetrapib 10 mg + ezetimibe 10 mg fixed dose combination (FDC) tablets
Placebo
干预措施: Placebo matching Obicetrapib 10 mg + ezetimibe 10 mg fixed dose combination (FDC) tablets (Drug)
Obicetrapib
Test
干预措施: Obicetrapib (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
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
The percent change from Baseline to Day 84 in LDL-C for obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the obicetrapib 10 mg monotherapy treatment group
The percent change from Baseline to Day 84 in LDL-C for obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the obicetrapib 10 mg monotherapy treatment group
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
- 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
- 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
- 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
- Percent change from Baseline to Day 84 in non-HDL-C for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group
- Percent change from Baseline to Day 84 in HDL-C for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group
- Percent change from Baseline to Day 84 in ApoB for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group
- Percent change from Baseline to Day 84 in ApoA1 for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group
- 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
- Percent change from Baseline to Day 84 in Lp(a) for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group
- Exploratory: Proportion of participants at Day 84 that achieve LDL-C <100 mg/dL (<2.6 mmol/L), LDL--C <70 mg/dL (<1.8 mmol/L), and LDL-C <55 mg/dL (<1.4 mmol/L) for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group and for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group
- Exploratory: Percent change from Baseline to Day 84 in particle numbers and size, as measured by NMR analysis, of LDL-C, HDL-C, and VLDL-C for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group and for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group
- Exploratory: Percent change from Baseline to Day 84 in sdLDL-C for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group and for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group
- Exploratory: Percent change from Baseline to Day 84 in HbA1c for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group and for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group
- OLE exploratory efficacy endpoints are assessed from Baseline at every visit for the following parameters: • Percent change from Baseline over time in LDL-C; • Proportion of participants that achieve LDL-C <100 mg/dL (<2.6 mmol/L), LDL-C <70 mg/dL (<1.8 mmol/L), and LDL-C <55 mg/dL (<1.4 mmol/L); • Percent change from Baseline over time in non-HDL-C, ApoB, total cholesterol, triglycerides, HDL-C, Lp(a)
研究者
Marc Ditmarsch
Scientific
NewAmsterdam Pharma B.V.
研究点 (24)
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