NL-OMON43654CompletedPhase 3
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients with Hypertriglyceridemia - ISIS CS-16 / Compass
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- IONIS Pharmaceuticals, Inc
- Enrollment
- 6
Study Overview
Brief Summary
Trial is onging in other countries
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •1. Must give written informed consent to participate in the study (signed and dated) and any authorizations by law
- •2. Age * 18 years at time of informed consent
- •3. BMI * 45kg/m²
- •4. Stable weight (+/- 4kg) for >6 weeks prior to screening
- •5. Fasting TG * 500mg/dL (* 5.7mmol/L)at Screening. If the fasting TG value at Screening is < 500mg/dL (< 5.7mmol/L) but *350mg/dL (* 4.0mmol/L) up to two additional tests may be performed in order to qualify
- •6. If on statin or fibrate, patients must be on stable, labeled dose for at least 3 months prior to screening that is not anticipated to change during the study treatment period. Patients not receiving these drugs within 4 weeks prior to screening are also eligible.
- •7. Fasting TG * 500mg/dL at Qualification Visit. IF fasting TG is < 500mg/dL but * 350mg/dL (* 4.0mmol/L) up to two additional tests may be performed in order to qualify.
- •8. Willing to maintain their customary activity level and to follow the NCEP ATP III TLC diet or similar with weight maintenance during the study.
- •9. Satisfy one of the following:
- •a. Females: Non-pregnant and non-lactating; surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), post-menopausal (defined as 12 months of spontaneous ameorrhea in females > 55 years of age or, in females * 55 years, 12 months of spontaneous ameorrhea without an alternative medical cause and FSH levels in the postmenopausal range for the laboratory involved), abstinent*, or if engaged in sexual relations and of child-bearing potential, patient is using an acceptable contraceptive method from time of signing the informed consent form until 13 weeks after the last dose of Study Drug administration
- •b. Males: Surgically sterile, abstinent* or if engaged in sexual relations with a female of child-bearing potential, patient is utilizing an acceptable contraceptive method from the time of signing the informed consent form until 13 weeks after the last dose fo Study Drug administration.
- •* Abstinence is only acceptable as true abstinence, i.e., when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of a trial and withdrawal are not acceptable methods of contraception
Exclusion Criteria
- •1. Type 1 diabetes mellitus
- •2. Type 2 Diabetes mellitus with any of the following:
- •a. Newly diagnosed within 12 weeks of screening
- •b. HbA1c * 9.0% at Screening
- •c. Recent change in anti-diabetic pharmacotherapy (change in dosage or addition of new medication within 12 weeks of screening [with the exception of +/- 10 units of insulin])
- •d. Anticipated need to change dose or type of medication during the treatment period of the Study (with the exception of +/- 10 units of insulin)
- •e. Current use of GLP-1 agonists, if patient has history of pancreatitis
- •3. Acute pancreatitis within 3 months of screening
- •4. History within 6 months of screening of acute or unstable cardiac ischemia (myocardial infarction, acute coronary syndrome, new onset angina), stroke, transient ischemic attack or unstable congestive cardiac failure requiring a change in medication or major surgery within 3 months of screening
- •5. Any of the following laboratory values at Screening:
- •a. Hepatic: Total bilirubin > upper limit of normal (ULN), unless prior diagnosis and documentation of Gilbert's syndrome in which case total bilirubin must be * 3mg/dL; ALT > 2.0x ULN; AST > 2.0 x ULN
- •b. Renal: Persistently positive (2 out of 3 tests * 1+) for protein on urine dipstick. In the event of positive test eligibility may be confirmed by a quantative total urine protein measurement of < 500mg/24hrs; Persistently positive (2 out of 3 tests * trace positive) for blood on urine dipstick. In the event of a positive test eligibility may be confirmed with urine microscopy showing * 5 red blood cells per high power field; Estimated creatinine clearance calculated according to the formula of Cockcroft and Gault < 50mL/min
- •c. Cardiac troponin I > ULN at Screening
- •d. LDL-C > 130mg/dL (> 3.4 mmol/L) at Screening for all patients and LDL-C > 100mg/dL (> 2.6 mmol/L) for patients with T2DM or history of MACE
- •e. any other laboratory abnormalities which, in the opinion of the Investigator or the Sponsor, would make the patient unsuitable for inclusion
- •6. Uncontrolled hypothyroidism (abnormal thyroid function tests should be approved by Study medical monitor)
- •7. Uncontrolled hypertension (BP > 160/100 mm Hg)
- •8. History of bleeding diathesis or coagulopathy or clinically significant abnormality in coagulation parameters at Screening
- •9. History of heart failure with NYHA greater than Class II
- •10. History of gastrointestinal malabsorption (e.g., uncontrolled Crohn's disease, etc.) or history of a gastric bypass or other diversional bariatric surgery
- •11. Gastric banding procedure within 1 year of screening
- •12. Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1
- •13. Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
- •14. Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated
- •15. Treatment with another investigational drug, biological agent, or device within one month of screening, or 5 half-lives of investigational agent, whichever is longer
- •16. History within 6 months of screening of drug or alcohol abuse
- •17. Unwilling to comply with lifestyle requirements
- •18. Use of any of the following medications:
- •a. Omega-3 fatty acids (prescription or OTC preparations) within 4 weeks of
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