Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Hypertriglyceridemia

Phase 1

• Conditions: Hypertriglyceridemia; MedDRA version: 18.1Level: LLTClassification code 10020870Term: HypertriglyceridemiaSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2014-003434-93-GB
• Lead Sponsor: Ionis Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-09
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

1. BMI = 45 kg/m2

2. Fasting TG = 500 mg/dL (= 5.7 mmol/L) at Screening.

3. If on statin or fibrate, patients must be on stable, labeled dose for at least 3 months prior to screening. Patients not receiving these drugs within 4 weeks prior to screening are also eligible.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1. Type 1 Diabetes mellitus

2. Newly diagnosed type 2 diabetes mellitus (within 12 weeks of screening) or HbA1c = 9.0% at Screening

3. Acute pancreatitis within 3 months of screening

4. Acute Coronary Syndrome within 6 months of screening

5. Gastric banding procedure within 1 year of screening

6. Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin of carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated

7. Treatment with another investigational drug, biological agent, or device within one month of screening.

8. Prior exposure to ISIS 304801

9. Have any other conditions in the opinion of the investigator which could interfere with the patient participating in our completing the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified