NL-OMON54297招募中2 期
A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults with Severe Hypertriglyceridemia - AROAPOC3-2001
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •To be eligible for enrollment, participants must meet all the following
- •inclusion criteria:
- •1. Males or nonpregnant (who do not plan to become pregnant), nonlactating
- •females >=18 years of age;
- •2. Based on medical history, evidence of triglycerides fasting (TG) >=500 mg/dL
- •(5.65 mmol/L) ;
- •3. A mean fasting TG >=500 mg/dL (5.65 mmol/L) and <=4000 mg/dL (45.2 mmol/L)
- •collected at two separate and consecutive visits at least 7 days apart and no
- •more than 14 days apart during the Screening period.
- •4. If the participant has a medical history of clinical atherosclerotic
- •cardiovascular disease (ASCVD) or those with elevated 10-year ASVCD risk (e.g.,
- •>=7.5% per American Heart Association / American College of Cardiology [ACC/AHA]
- •risk calculator) for subjects >=40 years of age or Framingham risk score
- •calculator for subjects under the age of 40) must be on appropriate
- •lipid-lowering therapy as per local standard of care (i.e., including moderate
- •to high intensity statin, as indicated) prior to collection of qualifying TG
- •5. Able and willing to provide written informed consent prior to the
- •performance of any study specific procedures;
- •6. Willing to follow diet counseling and maintain a stable diet as per
- •Investigator judgment based on local standard of care;
- •7. Participants of childbearing potential must agree to use highly effective
- •contraception, during the study and for at least 24 weeks following the last
- •dose of IP. Males must not donate sperm during the study and for at least 24
- •weeks following the or last dose of IP;
- •8. Women of childbearing potential on hormonal contraceptives must be stable on
- •the medication for >=2 menstrual cycles prior to Day 1; and
- •9. Participants on any of the following medications must be on a stable regimen
- •for the specified duration prior to collection of Screening visit (S2)
- •laboratory tests and for the duration of study participation:
- •Medication: Time on stable regimen prior to collection of Screening visit (S2)
- •laboratory tests
- •Lipid lowering therapies (including statins): >= 4 weeks
- •Beta-blockers, thiazide diuretics: >= 4 weeks
- •Fibrates: >= 6 weeks
- •PCSK9 inhibitors: >= 8 weeks
- •Retinoids: >= 8 weeks
- •Atypical antipsychotics: >= 12 weeks
- •Diabetes mellitus medications: >= 12 weeks
- •Anticoagulation therapy >=12 weeks
- •Thyroid hormone replacement therapy >=12 weeks
- •Testosterone replacement therapy >=16 weeks
- •Oral estrogens, tamoxifen, raloxifene: >= 16 weeks
- •Immunosuppressants: >= 24 weeks
- •NOTE: All laboratory tests used as inclusion criteria will be assessed by a
- •central laboratory and may be repeated once and the repeat value may be used
- •for inclusion purposes. Local laboratory testing may be permitted in limited
- •circumstances and only with prior Sponsor approval.
排除标准
- •Exclusion Criteria:
- •1. Current use or use within the last 365 days from Day 1 of any hepatocyte
- •targeted siRNA or antisense oligonucleotide molecule;
- •2. Active pancreatitis within 12 weeks prior to Day 1;
- •3. Known genetically confirmed diagnosis of Familial Chylomicronemia Syndrome
- •4. Any planned bariatric surgery or similar procedures to induce weight loss
- •during the period starting at consent through the end of the study;
- •5. History of major surgery within 12 weeks of Day 1 or planned major surgery
- •during the study;
- •6. Planned coronary intervention (such as stent placement or heart bypass)
- •during the study;
- •7. History of acute coronary syndrome event within 24 weeks of Day 1;
- •8. New York Heart Association (NYHA) Class II, III, or IV heart failure or last
- •known ejection fraction of <30%;
- •9. Uncontrolled hypertension (sitting blood pressure >160/100 mmHg at
- •Screening); participant may be re-screened once hypertension is controlled;
- •10. History of hemorrhagic stroke within 24 weeks of Day 1;
- •11. History of bleeding diathesis or coagulopathy;
- •12. Current diagnosis of nephrotic syndrome;
- •13. Any of the following laboratory values at Screening:
- •a. Hepatic: ALT or AST >2× ULN at Screening,
- •b. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (using the
- •Modification of Diet in Renal Disease [MDRD] equation) at Screening,
- •c. HbA1c >9.0% (or >75 mmol/mol [IFCC] units) at screening;
- •d. Spot urine protein/spot urine creatinine ratio >3 grams per day;
- •e. Clinically significant abnormality in PT, aPTT, or INR;
- •14. Use of any of the following:
- •a. Systemic use of corticosteroids or anabolic steroids within 4 weeks prior to
- •Day 1 or planned use during the study, (stable doses of testosterone
- •replacement therapy >16 weeks prior to Screening (visit S2) is permitted for a
- •documented history of hypogonadism [low testosterone] as verified in subject
- •health records)
- •b. Plasma apheresis within 4 weeks prior to Day 1 or planned during the study;
- •15. Blood donation of 50 to 499 mL within 4 weeks of Screening (visit S2)
- •laboratory collection or of >499 mL within 8 weeks of Screening (visit S2)
- •laboratory collection;
- •16. Known history of human immunodeficiency virus infection;
- •17. Seropositive (hepatitis B surface antigen [HBsAg] +) for hepatitis B virus
- •(HBV) or hepatitis C virus (HCV) (HCV seropositivity requires positive test for
- •antibodies confirmed with positive test for HCV RNA);
- •18. Clinical evidence of uncontrolled hypothyroidism or hyperthyroidism as per
- •Investigator*s judgment;
- •19. History of malignancy within the last 2 years prior to the date of consent
- •requiring systemic treatment except for adequately treated basal cell
- •carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ
- •cervical cancer. Currently receiving systemic cancer treatment(s) or, in the
- •Investigator's opinion, at risk of relapse for recent cancer;
- •20. Use of an investigational agent or device within 30 days or within 5
- •half-lives, based on plasma pharmacokinetics (PK) (whichever is longer) prior
- •to Day 1 or current participation in an interventional investigational study.
- 另有 3 项未显示
研究者
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