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

NCT07604974 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ION775-CS2
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Fasting Triglyceride (TG)

  Baseline, Month 6

Secondary Outcomes (6)

• Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)

  Up to 12 Months

• Number of Participants who Experience Abnormalities in Clinical Laboratory Evaluations

  Up to 12 Months

• Percent Change From Baseline in Fasting Apolipoprotein C-III (apoC-III)

  Baseline, Month 6

• Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C)

  Baseline, Month 6

• Percent Change From Baseline in Remnant Cholesterol When Directly Measured

  Baseline, Month 6

Study Arms (3)

ION775: Cohot A

EXPERIMENTAL

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

Drug: ION775

ION775: Cohot B

EXPERIMENTAL

Participants will be randomized to receive ION775 by SC injection.

Drug: ION775

ION775: Cohot C

EXPERIMENTAL

Participants will be randomized to receive ION775 by SC injection.

Drug: ION775

Interventions

ION775 DRUG

ION775 will be administered by SC injection.

ION775: Cohot A; ION775: Cohot B; ION775: Cohot C

Eligibility Criteria

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

You may qualify if:

• 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 \[5.65 mmol/L\]).
• Participants should be on standard of care lipid-lowering medications per local guidelines.

You may not qualify if:

• Hemoglobin A1c (HbA1c) ≥ 8.5% at Screening.
• Alanine aminotransferase or aspartate aminotransferase \> 2.0 × upper limit of normal.
• Total bilirubin \> 1.5 upper limit of normal unless due to Gilbert's syndrome.
• Estimated GFR \< 30 mL/min/1.73 m\^2.

Sponsors & Collaborators

• Ionis Pharmaceuticals, Inc.: lead

Study Sites (3)

Ionis Investigative Site

Lincoln, California, 95648, United States

RECRUITING

Ionis Investigative Site

Miramar, Florida, 33027, United States

RECRUITING

Ionis Investigative Site

Flint, Michigan, 48504, United States

RECRUITING

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ionis Pharmaceuticals, Inc.

CONTACT

1-844-828-3770; IonisION775-CS2@clinicaltrialmedia.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (3)