Recruiting
Phase 2

ION775

Sponsor:

Ionis Pharmaceuticals, Inc.

Code:

NCT07604974

Conditions

Hypertriglyceridemia

Severe Hypertriglyceridemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ION775

Study Details

Brief summary:

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

Study ID

NCT07604974

Start date

May 12, 2026

Status verified date

Sep, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key 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.

Key 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

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ION775: Cohot A

Participants will be randomized to receive ION775 by subcutaneous (SC) injection.

experimental: ION775: Cohot B

Participants will be randomized to receive ION775 by SC injection.

experimental: ION775: Cohot C

Participants will be randomized to receive ION775 by SC injection.

Interventions

ION775

ION775 will be administered by SC injection.

Primary outcome measure

  • Percent Change From Baseline in Fasting Triglyceride (TG) [ Time Frame: Baseline, Month 6 ]

Central Contacts and Locations

Central contacts

Locations

Ionis Investigative Site

Recruiting

Lincoln, California, United States, 95648

Ionis Investigative Site

Recruiting

Aurora, Colorado, United States, 80045

Ionis Investigative Site

Recruiting

Boca Raton, Florida, United States, 33434

Ionis Investigative Site

Recruiting

Miami, Florida, United States, 33184

Ionis Investigative Site

Recruiting

Miramar, Florida, United States, 33027

Ionis Investigative Site

Recruiting

Columbus, Georgia, United States, 31904

Ionis Investigative Site

Recruiting

Carmel, Indiana, United States, 46290

Ionis Investigative Site

Recruiting

Louisville, Kentucky, United States, 40213

Ionis Investigative Site

Recruiting

Flint, Michigan, United States, 48504

Ionis Investigative Site

Recruiting

Munroe Falls, Ohio, United States, 44262

Ionis Investigative Site

Recruiting

Little River, South Carolina, United States, 29566

Ionis Investigative Site

Recruiting

Houston, Texas, United States, 77040

Ionis Investigative Site

Recruiting

Lampasas, Texas, United States, 76550

Ionis Investigative Site

Recruiting

McKinney, Texas, United States, 75071

Ionis Investigative Site

Recruiting

Mesquite, Texas, United States, 75071

Ionis Investigative Site

Recruiting

San Antonio, Texas, United States, 78209

Ionis Investigative Site

Recruiting

Québec, Canada, G1V 4W2

More Information

Sponsor

Ionis Pharmaceuticals, Inc.

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Ionis Pharmaceuticals, Inc. on 2026-09-03.