A Study to Assess the Safety, Tolerability and Efficacy of ION775

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

  • Hypertriglyceridemia
  • Severe Hypertriglyceridemia

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
Miramar, Florida 33027

Ionis Investigative Site
Flint, Michigan 48504

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.