A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients with Hypertriglyceridemia - ISIS CS-16 / Compass

IONIS Pharmaceuticals, Inc0 sites6 target enrollmentTBD

Conditionshypertriglyceridemia 10013317

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: hypertriglyceridemia
Sponsor: IONIS Pharmaceuticals, Inc
Enrollment: 6
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Trial is onging in other countries

Registry

who.int

Start Date

TBD

End Date

December 29, 2016

Last Updated

2 years ago

Study Type

Interventional

Investigators

Sponsor

IONIS Pharmaceuticals, Inc

Eligibility Criteria

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

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: