Health TrialsbyHealthPanel

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

ConditionsHypertriglyceridemiaSevere Hypertriglyceridemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIonis Pharmaceuticals, Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 m².

Trial design

Design model

Parallel

Treatments tested in this trial

  • ION775

    Drug

    ION775 will be administered by SC injection.

Treatment groups

72 Participants
are divided into 3 treatment groups
Group A: ION775: Cohot AExperimental treatment 1 intervention
Group B: ION775: Cohot BExperimental treatment 1 intervention
Group C: ION775: Cohot CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percent Change From Baseline in Fasting Triglyceride (TG)

Time frame
Baseline, Month 6

Secondary outcomes

1

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

Time frame
Up to 12 Months
2

Number of Participants who Experience Abnormalities in Clinical Laboratory Evaluations

Time frame
Up to 12 Months
3

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

Time frame
Baseline, Month 6
4

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

Time frame
Baseline, Month 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ionis Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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