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NCT05681351 · ClinicalTrials.gov registry record · Phase 3

CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)

A Phase 3 study of Severe Hypertriglyceridemia, sponsored by Ionis Pharmaceuticals.

Active
Registry status
Phase 3
Development phase
885
Enrollment target
20
Study locations

NCT05681351 is a Phase 3 study of Severe Hypertriglyceridemia that is active but no longer recruiting, run by Ionis Pharmaceuticals. The registered enrollment target is 885 participants, above the 315-participant average among 8 other Severe Hypertriglyceridemia trials with a reported enrollment target (181% higher). The trial reports 20 study locations across 7 states.

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The verdict

NCT05681351, a Phase 3 study of Severe Hypertriglyceridemia, is active but no longer recruiting, sponsored by Ionis Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
885 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.

Conditions Studied

Severe Hypertriglyceridemia

Interventions

  • DRUG Olezarsen

Study Locations (20)

Florida

  • Excel Medical Clinical Trials - Boca Raton
  • Finlay Medical Research - Greenacres City
  • Columbus Clinical Services, LLC - Miami
  • Finlay Medical Research - Miami
  • Innovia Research Center, Inc. - Miramar
  • Harmony Clinical Research, Inc. - North Miami Beach
  • R & B Medical Center LLC - Tampa
  • VICIS Clinical Research - Tampa
  • JSV Clinical Research Study, Inc. - Tampa
  • Bayside Clinical Research - Trinity

California

  • LA Universal Research Center, Inc. - Los Angeles
  • University of California, San Diego (UCSD) - San Diego
  • Metabolic Institute of America - Tarzana

Georgia

  • Centricity Research - Columbus
  • IACT Health - Columbus

Kentucky

  • The Research Group of Lexington, LLC - Lexington
  • Louisville Metabolic and Atherosclerosis Research Center (L-MARC) - Louisville

Illinois

  • Affinity Health - Oak Brook

Indiana

  • St. Vincent Medical Group, Inc. - Carmel

Kansas

  • University of Kansas Medical Center (KUMC) - Kansas City

Trial Details

FieldValue
Enrollment Target 885 participants
Start Date 2022-12-13
Est. Completion 2027-03
Phase Phase 3

Sponsor

Ionis Pharmaceuticals

76 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05681351

The ClinicalTrials.gov registry entry for NCT05681351 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 885 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 315-participant average among 8 other Severe Hypertriglyceridemia trials with a reported enrollment target (181% higher). The listed sponsor is Ionis Pharmaceuticals, which has 76 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Severe Hypertriglyceridemia appearing as the primary indexed condition, and to 1 intervention - of which Olezarsen is the first listed.

NCT05681351 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT05681351 about?

NCT05681351 is a clinical study titled "CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)". The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.

What is the current status of trial NCT05681351?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 885 participants. The study started on 2022-12-13. Estimated completion is 2027-03.

What conditions does trial NCT05681351 study?

This clinical trial studies the following conditions: Severe Hypertriglyceridemia.

What interventions are being tested in trial NCT05681351?

The interventions under investigation include: Olezarsen (DRUG).

Who is sponsoring clinical trial NCT05681351?

This trial is sponsored by Ionis Pharmaceuticals, which has 76 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05681351 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.