Impact of Triglyceride-Lowering on Inflammatory Activity in Patients with Hypertriglyceridemia

Phase 2

Recruiting

• Conditions: high levels of triglyceride; Hypertriglyceridemia; 10003216

• Registration Number: NL-OMON51943
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- Adults between 18 and 75 years old
- Triglycerides > 4mmol/l (350 mg/dl)

Exclusion Criteria

- Molecularly diagnosed familial chylomicronemia syndrome (homozygous and/or
compound heterozygous)
- Use of fibrates or fish oil: both have to be discontinued (if possible,
triglyceride levels should not exceed 10 mmol/l) for at least 4 weeks prior to
baseline visit
- Uncontrolled diabetes (HBa1C > 90 mmol/L)
- Body mass index (BMI) > 45.0 kg/m2
- Uncontrolled hypertension (systolic > 180mmHg; diastolic > 105mmHg)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcomes are:<br /><br>• The impact of ISIS 678354 on a mass cytometry monocyte phenotype panel;<br /><br>expression markers such as CD14 and CD16.<br /><br>• Postprandial triglyceride AUC change at the primary analysis time point from<br /><br>baseline of the treatment group as compared to placebo.</p><br>