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

NCT02300233 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: ISIS 304801-CS162014-003434-93
• Study Type: interventional
• Target: 114
• Locations: 6 countries
• Sites: 45

Brief Summary

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

Conditions

Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

• Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3

  Baseline to 3 months

Secondary Outcomes (6)

• Absolute Change in Fasting TG From Baseline to Month 3

  Baseline to 3 months

• Treatment Response Rate Defined as Participants With Fasting TG ≥ 40% Reduction From Baseline at 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 < 150 mg/dL Reduction From Baseline at Month 3

  Baseline to 3 months

• Change From Baseline in Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)

  Baseline to 3 and 6 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.

Drug: Placebo

Volanesorsen 300 mg weekly

EXPERIMENTAL

Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks.

Drug: Volanesorsen

Volanesorsen 300 mg biweekly, post Week 13

EXPERIMENTAL

Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.

Drug: Volanesorsen

Interventions

Volanesorsen DRUG

300 mg volanesorsen administered subcutaneously once-weekly for 26 weeks.

Also known as: ISIS 304801

Volanesorsen 300 mg biweekly, post Week 13; Volanesorsen 300 mg weekly

Placebo DRUG

Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) ≤ 45 kg/m2
• Fasting Triglycerides (TG) ≥ 500 mg/dL (≥ 5.7 mmol/L) at Screening.
• 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.

You may not qualify if:

• Type 1 diabetes mellitus
• Newly diagnosed type 2 diabetes mellitus (within 12 weeks of screening) or HbA1c ≥ 9.0% at Screening
• Acute pancreatitis within 3 months of screening
• Acute Coronary Syndrome within 6 months of screening
• Major surgery within 3 months of screening
• Prior exposure to ISIS 304801
• Have any other conditions in the opinion of the investigator which could interfere with the participant participating in or completing the study

Sponsors & Collaborators

• Ionis Pharmaceuticals, Inc.: lead
• Akcea Therapeutics: collaborator

Study Sites (45)

IONIS Investigative Site

Encinitas, California, 92024, United States

Location

IONIS Investigative Site

San Francisco, California, 94143, United States

Location

IONIS Investigative Site

Boca Raton, Florida, 33434, United States

Location

IONIS Investigative Site

Miami, Florida, 33147, United States

Location

IONIS Investigative Site

Sterling, Illinois, 61081, United States

Location

IONIS Investigative Site

Kansas City, Kansas, 66160, United States

Location

IONIS Investigative Site

Salisbury, Maryland, 73103, United States

Location

IONIS Investigative Site

Towson, Maryland, 21204, United States

Location

IONIS Investigative Site

Boston, Massachusetts, 02114, United States

Location

IONIS Investigative Site

Grandville, Michigan, 49418, United States

Location

IONIS Investigative Site

North Massapequa, New York, 11758-1802, United States

Location

IONIS Investigative Site

Benson, North Carolina, 27504, United States

Location

IONIS Investigative Site

Chapel Hill, North Carolina, 27609, United States

Location

IONIS Investigative Site

Farmville, North Carolina, 27828, United States

Location

IONIS Investigative Site

Greenville, North Carolina, 27834, United States

Location

IONIS Investigative Site

Morrisville, North Carolina, 27560, United States

Location

IONIS Investigative Site

Raleigh, North Carolina, 27612, United States

Location

IONIS Investigative Site

Wilson, North Carolina, 27609, United States

Location

IONIS Investigative Site

Wilson, North Carolina, 27893, United States

Location

IONIS Investigative Site

Cincinnati, Ohio, 45227, United States

Location

IONIS Investigative Site

Kettering, Ohio, 45429, United States

Location

IONIS Investigative Site

Marion, Ohio, 43302, United States

Location

IONIS Investigative Site

Oklahoma City, Oklahoma, 73103, United States

Location

IONIS Investigative Site

Portland, Oregon, 97239, United States

Location

IONIS Investigative Site

Providence, Rhode Island, 02906, United States

Location

IONIS Investigative Site

Houston, Texas, 77030, United States

Location

IONIS Investigative Site

Salt Lake City, Utah, 84108, United States

Location

IONIS Investigative Site

Norfolk, Virginia, 23510, United States

Location

IONIS Investigative Site

Seattle, Washington, 98104, United States

Location

IONIS Investigative Site

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

IONIS Investigative Site

London, Ontario, N6A 5B7, Canada

Location

IONIS Investigative Site

Chicoutimi, Quebec, G7H 7K9, Canada

Location

IONIS Investigative Site

Sainte-Foy, Quebec, G1V 4M6, Canada

Location

IONIS Investigative Site

Dijon, 21079, France

Location

IONIS Investigative Site

Marseille, 13385, France

Location

IONIS Investigative Site

Paris, 75013, France

Location

IONIS Investigative Site

Saint-Herblain, France

Location

IONIS Investigative Site

Cologne, North Rhine-Westphalia, 50937, Germany

Location

IONIS Investigative Site

Berlin, 13353, Germany

Location

IONIS Investigative Site

Dresden, 01307, Germany

Location

IONIS Investigative Site

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

IONIS Investigative Site

Rotterdam, South Holland, 3045 PM, Netherlands

Location

IONIS Investigative Site

Utrecht, 3584 CX, Netherlands

Location

IONIS Investigative Site

Manchester, M23 9LT, United Kingdom

Location

IONIS Investigative Site

Peterborough, PE3 6DA, United Kingdom

Location

Related Publications (2)

• Prohaska TA, Alexander VJ, Karwatowska-Prokopczuk E, Tami J, Xia S, Witztum JL, Tsimikas S. APOC3 inhibition with volanesorsen reduces hepatic steatosis in patients with severe hypertriglyceridemia. J Clin Lipidol. 2023 May-Jun;17(3):406-411. doi: 10.1016/j.jacl.2023.04.007. Epub 2023 Apr 27.

  PMID: 37164837 DERIVED

• Gouni-Berthold I, Alexander VJ, Yang Q, Hurh E, Steinhagen-Thiessen E, Moriarty PM, Hughes SG, Gaudet D, Hegele RA, O'Dea LSL, Stroes ESG, Tsimikas S, Witztum JL; COMPASS study group. Efficacy and safety of volanesorsen in patients with multifactorial chylomicronaemia (COMPASS): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2021 May;9(5):264-275. doi: 10.1016/S2213-8587(21)00046-2. Epub 2021 Mar 30.

  PMID: 33798466 DERIVED

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

ISIS 304801

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Ionis Pharmaceuticals, Inc.
• Organization: Ionis Pharmaceuticals, Inc.

patients@ionisph.com

800-679-4747

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 24, 2014
• Study Start: February 5, 2015
• Primary Completion: July 27, 2016
• Study Completion: January 24, 2017
• Last Updated: April 13, 2022
• Results First Posted: April 13, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4); US (29); CA (4); DE (3); NL (3); GB (2)