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Purpose

The main objective of this study is to evaluate the effect of ION775 on fasting triglyceride (TG) levels in participants with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (sHTG).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Adult males and females with HTG (fasting TG more than or equal to (≥) 350 milligrams per deciliter (mg/dL) [3.95 millimoles per liter (mmol/L)] or with sHTG (fasting TG ≥ 500 mg/dL [5.65 mmol/L]). 2. Participants should be on standard of care lipid-lowering medications per local guidelines.

Exclusion Criteria

  1. Hemoglobin A1c (HbA1c) ≥ 8.5% at Screening. 2. Alanine aminotransferase or aspartate aminotransferase > 2.0 × upper limit of normal. 3. Total bilirubin > 1.5 upper limit of normal unless due to Gilbert's syndrome. 4. Estimated GFR < 30 mL/min/1.73 m^2. Note: Other protocol pre-specified inclusion/exclusion criteria may apply.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ION775: Cohot A 		Participants will be randomized to receive ION775 by subcutaneous (SC) injection.
  • Drug: ION775
    ION775 will be administered by SC injection.
Experimental
ION775: Cohot B 		Participants will be randomized to receive ION775 by SC injection.
  • Drug: ION775
    ION775 will be administered by SC injection.
Experimental
ION775: Cohot C 		Participants will be randomized to receive ION775 by SC injection.
  • Drug: ION775
    ION775 will be administered by SC injection.

Recruiting Locations

Ionis Investigative Site
Lincoln, California 95648

Ionis Investigative Site
Aurora, Colorado 80045

Ionis Investigative Site
Boca Raton, Florida 33434

Ionis Investigative Site
Miami, Florida 33184

Ionis Investigative Site
Miramar, Florida 33027

Ionis Investigative Site
Columbus, Georgia 31904

Ionis Investigative Site
Carmel, Indiana 46290

Ionis Investigative Site
Louisville, Kentucky 40213

Ionis Investigative Site
Flint, Michigan 48504

Ionis Investigative Site
Munroe Falls, Ohio 44262

Ionis Investigative Site
Little River, South Carolina 29566

Ionis Investigative Site
Houston, Texas 77040

Ionis Investigative Site
Lampasas, Texas 76550

Ionis Investigative Site
McKinney, Texas 75071

Ionis Investigative Site
Mesquite, Texas 75071

Ionis Investigative Site
San Antonio, Texas 78209

More Details

Status
Recruiting
Sponsor
Ionis Pharmaceuticals, Inc.

Study Contact

Ionis Pharmaceuticals, Inc.
1-844-828-3770
IonisION775-CS2@clinicaltrialmedia.com

Detailed Description

This is an open-label, parallel-dose study consisting of a 4-6 week screening period, a 6-month treatment period and a 6-month post-treatment follow-up period.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.