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

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients with Hypertriglyceridemia - The COMPASS Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003434-93-DE

Enrollment

105

Registered

2014-11-26

Start date

2015-01-07

Completion date

Unknown

Last updated

2018-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia MedDRA version: 19.0 Level: LLT Classification code 10020870 Term: Hypertriglyceridemia System Organ Class: 100000004861

Interventions

Product Name: ApoC-III Antisense Oligonucleotide Product Code: ISIS 304801 Pharmaceutical Form: Solution for injection INN or Proposed INN: ISIS 304801 CAS Number: 915430-78-3 Current Sponsor code: IS

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of ISIS 304801 (300 mg once weekly) as compared to placebo on the percent change in fasting TG from baseline.;Secondary Objective: To evaluate the efficacy of ISIS 304801 as compared to placebo on the following: -Absolute change from baseline in fasting TG -Proportion of patients who achieve = 40% reduction from baseline in fasting TG -Percent change from baseline in HDL-C -Proportion of patients who achieve fasting TG < 150 mg/dL -Change from baseline in HOMA-IR -Change from baseline in HbA1c in T2DM patients;Primary end point(s): The % change in fasting TG from baseline as measured at the primary analysis time point. ;Timepoint(s) of evaluation of this end point: The primary analysis time point is at the end of Month 3 where the value is defined as the average of Week 12 and Week 13 fasting assessments	—

Measure

Time frame

Main Objective: To evaluate the efficacy of ISIS 304801 (300 mg once weekly) as compared to placebo on the percent change in fasting TG from baseline.;Secondary Objective: To evaluate the efficacy of ISIS 304801 as compared to placebo on the following: -Absolute change from baseline in fasting TG -Proportion of patients who achieve = 40% reduction from baseline in fasting TG -Percent change from baseline in HDL-C -Proportion of patients who achieve fasting TG < 150 mg/dL -Change from baseline in HOMA-IR -Change from baseline in HbA1c in T2DM patients;Primary end point(s): The % change in fasting TG from baseline as measured at the primary analysis time point. ;Timepoint(s) of evaluation of this end point: The primary analysis time point is at the end of Month 3 where the value is defined as the average of Week 12 and Week 13 fasting assessments

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Secondary

Measure	Time frame
Secondary end point(s): The secondary endpoints include: -Absolute change from baseline in fasting TG -Proportion of patients who achieve = 40% reduction from baseline in fasting TG -Percent change from baseline in HDL-C -Proportion of patients who achieve fasting TG < 150 mg/dL -Change from baseline in HOMA-IR -Change from baseline in HbA1c in T2DM patients;Timepoint(s) of evaluation of this end point: At the end of Month 3 where the value is defined as the average of Week 12 (Day 78) and Week 13 (Day 85) fasting assessments.	—

Measure

Time frame

Secondary end point(s): The secondary endpoints include: -Absolute change from baseline in fasting TG -Proportion of patients who achieve = 40% reduction from baseline in fasting TG -Percent change from baseline in HDL-C -Proportion of patients who achieve fasting TG < 150 mg/dL -Change from baseline in HOMA-IR -Change from baseline in HbA1c in T2DM patients;Timepoint(s) of evaluation of this end point: At the end of Month 3 where the value is defined as the average of Week 12 (Day 78) and Week 13 (Day 85) fasting assessments.

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Countries

Canada, France, Germany, Netherlands, United Kingdom, United States

Contacts

Public ContactTeresa Brandt

Ionis Pharmaceuticals, Inc.

tbrandt@ionisph.com+1760603-2738

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026