EUCTR2020-000641-13-PL进行中（未招募）1 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy and Safety of BIO89-100 in Subjects with Severe Hypertriglyceridemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 89bio, Inc.
- 入组人数
- 90
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
- 性别
- All
入选标准
- •1. Subject understands the study design and has been informed of the investigational nature
- •of the study. Subject has given voluntary, written, informed consent to take part in this
- •2. Subject agrees to be compliant and is a capable of completing the required study
- •assessments.
- •3. Male or female age =21 to =75 years at time of signing informed consent.
- •4. All subjects (male or female) who are of childbearing potential must agree to use
- •highly-effective, double contraception (both male and female partners) during the study.
- •Double contraception is defined as use of a condom by the male partner, combined with
- •use of 1 of the following forms of highly-effective contraception by the female partner:
- •a. Oral contraceptive pills
- •b. Depot or injectable contraceptive
- •c. Intrauterine device (IUD)
- •d. Contraceptive patch (e.g., Xulane®) or NuvaRing®
- •e. Documented evidence of surgical sterilization at least 6 months prior to the
- •screening visit (i.e., tubal ligation or hysterectomy).
- •Use of a condom in a male subject who underwent vasectomy is also acceptable as
- •double contraception. Use of highly-effective, double contraception must continue for
- •30 days or 5 half-lives (whichever is longer) after the last dose of investigational product.
- •Female subjects should not donate oocytes during this time. Male subjects must not
- •donate sperm during this time. Rhythm methods are not considered as highly-effective
- •methods of birth control. Subject abstinence for the duration of the study and 30 days or
- •5 half-lives (whichever is longer) after last dose of investigational product is acceptable if
- •it is the subject’s regular practice.
- •5. Females of childbearing potential must have a negative serum pregnancy test at screening
- •V2 and a negative urine pregnancy test on Day 1. Females of childbearing potential must
- •agree to undergo a urine pregnancy test prior to each administration of investigational
- •product and at the end of the treatment, and a serum pregnancy test at end of the study.
- •6. Females not of childbearing potential will be defined for this study as postmenopausal
- •(defined as cessation of regular menstrual periods for at least 12 months) and confirmed
- •by follicle-stimulating hormone (FSH) level OR surgically sterile.
- •7. Serum TG criteria meeting all of the following criteria:
- •a. A historical documented TG =400 mg/dL (4.52 mmol/L) in the past 5 years from
- •screening V1, or currently on lipid modifying therapy due to SHTG at
- •screening V1.
- •b. Mean of 2 screening fasting serum TGs =500 mg/dL (5.65 mmol/L) and
- •=2000 mg/dL (22.60 mmol/L). Mean screening fasting serum TG is defined as the
- •mean of TG at V2 and V3, or V3 and V3.1 if the average of TG at V2 and V3 is
- •<500 mg/dL, or >2000 mg/dL. The repeat measure of TG is permitted at a
- •minimum of 7 days apart at V3.1.
- •c. If 1 of the 2 qualifying TGs is <400 mg/dL, the difference between 2 TG should
- •be <300 mg/dL.
- •8. Willing to follow a lifestyle for optimal control of TGs and disease management during
- •the study e.g., lipid modifying, and approximately isocaloric diet and exercise. At the
- •screening and subsequent visit, all subjects will receive counseling regarding the National
- •Cholesterol Education Program Therapeutic Lifestyle Changes Diet.
- •9. Concomitant medication may include prescription fish oil (including purified
- •eicosapentaenoic acid [EPA] with or without docosahexaenoic acid [DHA]) and/or statin
- •with or without ezetimibe (none of which will be supplied as part of study) as long as the
排除标准
- •1. Females who are pregnant or breastfeeding, or planning to become pregnant, or breastfeed while enrolled in the study or within 30 days or 5 half-lives (whichever is longer) after last dose of investigational product.
- •2. Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg) at screening V1.
- •3. Body mass index (BMI) >45 kg/m2 at screening V1.
- •4. Weight change =5% in 3 months prior to screening V1 or weight change =5% between screening V1 and V3.
- •5. Central laboratory hemoglobin levels below the lower limit of normal (<12.0 g/dL for males, <11.0 g/dL for females), or dialysis, lipid apheresis, plasma exchange, blood transfusion, or blood donation/blood loss of =400 mL at least a month prior to and during the screening period or anticipation of these procedures during the period of the study and up to 30 days afterwards.
- •6. A history of symptomatic gallstone disease unless treated with cholecystectomy and/or pancreatitis within 5 years from screening will be excluded from the study.
- •7. ALT or AST >3× upper limit of normal (ULN) at screening V1.
- •8. Total bilirubin exceeds ULN at screening V1, unless prior diagnosis and documentation of Gilbert’s syndrome in which case total bilirubin must be =3 mg/dL.
- •9. Creatine kinase (CK) >3× ULN at screening V1.
- •10. Risky drinking within the 24 months before screening V1, or had positive alcohol test at screening V1 or at V4. Alcohol intake will be limited to 2 units of alcohol per day for men and 1 unit of alcohol per day for women.
- •11. Concomitant use of fibrates, PCSK9 inhibitors, niacin, or any supplements, including non-prescription, non-pharmaceutical strength fish oils, used to alter lipid metabolism.
- •12. Previous long-term (>4 weeks) use of systemic steroid (glucocorticoid) medications such as prednisone within 12 months of screening V1. Inhaled or topical corticosteroids are permitted.
- •13. Reduced renal function (eGFR =60 mL/min/1.73 m2 calculated using chronic kidney disease epidemiology collaboration [CKD-EPI] equation).
- •14. Positive for hepatitis b virus (HBV), hepatitis c virus (HCV) or human immunodeficiency virus (HIV). HBV and HCV determined by antibodies first and, if positive, by DNA/ribonucleic acid (RNA).
- •15. History of drug abuse, or any other substance dependence (with the exception of caffeine) in the past 2 years prior to screening or a positive test for drugs of abuse at screening V1.
- •16. Participation in a previous clinical trial or exposure to another investigational drug within 12 weeks or 5 half-lives, whichever is longer, prior to screening.
- •17. Previous exposure to an FGF21 analog or FGFR1 activating product, or known sensitivity to PEG or any of the excipients.
- •18. Type 1 diabetes mellitus (T1DM).
- •19. Diagnosis of Type 2 diabetes mellitus (T2DM) <6 months prior to screening.
- •20. Subjects with T2DM diagnosed =6 months prior to screening must have a HbA1c <9.5%, and, if receiving antidiabetic medications, must be on a stable dose of antidiabetic medications before screening (6 months for glucagon-like peptide 1 analogs or dipeptidyl peptidase IV inhibitor; 3 months for other oral or injectable medications; insulin injection is NOT allowed in this study).
- •21. History of malignancy within 5 years prior to screening V1, other than successfully treated basal or squamous cell carcinoma or localized cervical carcinoma.
- •22. Inadequately controlled thyroid disorders. Subjects on thyroid replacement should be on stable doses for at
研究者
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