EUCTR2020-000065-16-DE进行中（未招募）1 期
A Randomised, Double-Blind, Placebo-Controlled, Dose Finding Phase IIb Study to Assess the Efficacy and Safety of Orally Administered Epeleuton in Patients with Hypertriglyceridemia and Type 2 Diabetes. - TRIglyceride And Glucose control with Epeleuton in Metabolic Syndrome Patients (TRIAGE)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients diagnosed with type 2 diabetes mellitus at least 90 days prior to the first screening visit.
- •2. Patients with a HbA1C (glycosylated haemoglobin) between 7.0 - 10.0% (53-86 mmol/mol) (both inclusive)
- •3. Patients with a fasting triglyceride level =200 mg/dL (2.26 mmol/L) and <750mg/dL (8.46 mmol/L) at both screening visits.
- •Note: If the triglyceride level is outside the required range at the second screening visit, an additional measurement can be obtained 1 week later, to confirm eligibility.
- •Note: If a large difference in triglyceride level (>15%) is observed between screening 1 and screening 2, an additional measurement may be requested or patient may be deemed not eligible.
- •4. Patients who have been educated regarding diet and exercise at or before visit 1 (screening 1) and are willing to maintain and not alter a stable diet and activity routine throughout the study.
- •5. Patients who have been on a stable statin therapy at doses that are likely to achieve optimal LDL cholesterol and who are willing to continue this treatment throughout the study.
- •Note: Stable statin therapy may consist of a statin with or without ezetimibe.
- •6. Patients with an LDL cholesterol level <130mg/dL (3.34 mmol/L) at both screening visits.
- •7. Patients who have a body mass index (BMI) = 25kg/m2 and <50kg/m2.
- •8. Patients who have been on a stable daily dose of metformin (at least 1500mg or maximum tolerated dose for metformin monotherapy as documented in the subject medical record) and/or a sulfonylurea and/or a dipeptidyl peptidase-4 (DPP-4) inhibitor and/or a sodium-glucose transport protein 2 inhibitor (SGLT2i) and/or a GLP1-RA and/or basal insulin for at least 90 days prior to the day of first screening visit.
- •Note: Dose of GLP1-RA must be stable for 6 months prior to baseline with no weight change >2kg for 3 months prior to baseline.
- •Note: Dose of basal insulin must be stable for 4 months prior to baseline. All types of basal insulin are permitted, including insulin glargine, insulin degludec, insulin detemir, NPH insulin and pre-mixed insulin.
- •9. Female patients and male patients with female partners of childbearing potential must use highly effective contraceptive methods or have a sterilised partner for the duration of the study. Highly effective contraceptive methods are defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include hormonal contraception, intrauterine device or sexual abstinence.
- •Note: A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- •Note: Hormonal contraceptives must be on a stable dose for at least one month before baseline.
- •Note: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient.
- •10. Patients whose pre-study or screening clinical laboratory findings do not interfere with their participation in the study, in the opinion of the Investigator, and do not violate any inclusion or exclusion criteria
- •11. Male or female patients aged 18 years and older on t
排除标准
- •1. Patients who have a history of intolerance or hypersensitivity to any substance in epeleuton capsules, placebo capsules or statins.
- •2. Patients with uncontrolled hypertension defined as a systolic blood pressure =160 mmHg or a diastolic blood pressure =100mmHg.
- •3. Patients who have a body mass index (BMI) <25kg/m2 or = 50kg/m2.
- •4. Patients who have a weight change >2kg from the first screening visit to the baseline visit.
- •5. Patients who have type 1 diabetes mellitus.
- •6. Patients who have thyroid stimulating hormone (TSH) levels >1.5 times the upper limit of normal.
- •7. Patients with known familial lipoprotein lipase deficiency (Fredriksen type I), apolipoprotein C-II deficiency or familial dysbetaliproteinemia (Fredriksen type III).
- •8. Patients with significant liver disease or liver function impairment defined as any of the following; cirrhosis, hepatitis, biliary obstruction with hyperbilirubinemia (total bilirubin >2 times the upper limit of normal) and aspartate aminotransferase (AST) or alanine aminotransferase levels (ALT) >3 times the upper limit of normal.
- •9. Patients with renal impairment defined as an estimated glomerular filtration rate <50mL/min/1.73m2 as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
- •10. Patients with a history of malignancies within the past 5 years other than curatively treated non-melanoma skin cancer (basal cell or squamous cell carcinomas).
- •11. Patients who have been treated with any investigational product within 60 days prior to visit 1 (Screening 1), or 5 half-lives (whichever is longer). Patients cannot participate in any other investigational medication or medical device trial while participating in this study.
- •12. Patients who have used dietary supplements or prescription products rich in omega-3 or omega-6 fatty acids in the four weeks prior to baseline.
- •13. Patients who have been treated with any medication for diabetes or obesity in the four weeks before the baseline visit, except for metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, basal insulin, GLP1-RAs (must be on a stable dose for at least 6 months) and short-term insulin treatment for acute illness for a total of below or equal to 14 days.
- •14. Patients who have been treated with fibrates, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, bile acid sequestrants, niacin, niacin analogues or dietary supplements for the purpose of lowering triglycerides or cholesterol in the six weeks prior to baseline.
- •15. Patients who have a family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinomas.
- •16. Patients who have a history of acute or chronic pancreatitis.
- •17. Patients who have a history of major surgical procedures involving the stomach potentially affecting absorption of investigational medicinal product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
- •18. Patients who have planned major surgical procedures, coronary intervention (such as stent placement or heart bypass), carotid or peripheral revascularisation.
- •19. Patients who have a history of myocardial infarction, stroke, coronary revascularisation or hospitalisation for unstable angina in the 3 months prior to screening.
- •20. Patients with creatine kinase concentrations > 10 times the upper limit of normal or creatine kinase elevation due to known muscle disease at visit 1 (screening 1)
- •21. Patients who are classified as being in New York Heart Association (
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