The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia

Phase 3

Completed

• Conditions: Hypertriglyceridemia
• Interventions: Drug: Placebo; Drug: Volanesorsen

• Registration Number: NCT02300233
• Lead Sponsor: Ionis Pharmaceuticals, Inc.

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in participants with Hypertriglyceridemia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2014-11-21
• Study First Posted: 2014-11-24
• Study Start: 2015-02-05
• Primary Completion: 2016-07-27
• Study Completion: 2017-01-24
• Disposition First Submitted: 2018-05-07
• Disposition First Submitted QC: 2018-05-07
• Disposition First Posted: 2018-05-09
• Results First Submitted: 2022-01-13
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-17
• Last Update Submitted: 2022-03-17
• Results First Posted: 2022-04-13
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

1. Body mass index (BMI) ≤ 45 kg/m2
2. Fasting Triglycerides (TG) ≥ 500 mg/dL (≥ 5.7 mmol/L) at Screening.
3. If on statin or fibrate, participants must be on stable, labeled dose for at least 3 months prior to screening. Participants not receiving these drugs within 4 weeks prior to screening are also eligible.

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. Major surgery within 3 months of screening
6. Prior exposure to ISIS 304801
7. Have any other conditions in the opinion of the investigator which could interfere with the participant participating in or completing the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
Volanesorsen 300 mg weekly	Volanesorsen	Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks.
Volanesorsen 300 mg biweekly, post Week 13	Volanesorsen	Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.

Primary Outcome Measures

Name	Time	Method
Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3	Baseline to 3 months

Secondary Outcome Measures

Name	Time	Method
Absolute Change in Fasting TG From Baseline to Month 3	Baseline to 3 months
Percent Change in High-density Lipoprotein-cholesterol (HDL-C) From Baseline	Baseline to 3 months
Treatment Response Rate Defined as Participants With Fasting TG ≥ 40% Reduction From Baseline at Month 3	Baseline to 3 months
Treatment Response Rate Defined as Participants With Fasting TG < 150 mg/dL Reduction From Baseline at Month 3	Baseline to 3 months	mg/dL = milligrams per deciliter
Change From Baseline in Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)	Baseline to 3 and 6 months	HOMA-IR was calculated using the following formula: fasting insulin micro-international units per millimeter (μIU/mL) x fasting glucose mg/dL\]/405. A negative change from baseline indicates improvement; a positive change from baseline indicates worsening.
Change From Baseline in Glycated Hemoglobin (HbA1c) in Type 2 Diabetes Mellitus (T2DM) Participants	Baseline to 3 and 6 months

Trial Locations

Locations (1)

IONIS Investigative Site; 🇬🇧 Peterborough, United Kingdom