Impact on inflammation in lowering levels of triglycerides in patients

Phase 1

• Conditions: - Hypertriglyceridemia - Inflammation- Lipoproteins; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-003168-28-NL
• Lead Sponsor: Academic Medical Center (AMC), department of Internal Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-02
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

- Adults above 18 years old
- Triglyceride levels > 4mmol/l (350 mg/dl)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Molecularly diagnosed familial chylomicronemia syndrome (homozygous and/or compound heterozygous)
- Use of fibrates or fish oil: both have to be discontinued for at least 4 weeks prior to baseline visit
- Uncontrolled diabetes (HBa1C > 70 mmol/mol)
- Alcohol intake > 4c/day
- ASAT/ALAT > 3x ULN
- Renal insufficiency, defined as eGFR < 30 ml/min
- Platelet count < 150.000 and > 450.000 /mm3
- Pancreatitis < 8 weeks prior to baseline visit
- Body mass index (BMI) > 35.0 kg/m2
- Premenopausal women not using birth-control
- Uncontrolled hypertension (systolic > 180 mmHg; diastolic > 105 mmHg)
- Diagnosis of (active) malignancy in last 5 years
- Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator
- Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the impact of AKCEA-APOCIII-LRx on lipid and inflammatory measurements in the fasting and postprandial phase.;Secondary Objective: Study the impact of AKCEA-APOCIII-LRx on 15 expression markers on monocyte phenotyping using mass cytometry.;Timepoint(s) of evaluation of this end point: The primary analysis time point is at 7 weeks. ;Primary end point(s): - The mean percentage change in fasting apoC-III and triglyceride reduction between the treatment and placebo group, at the primary analysis time point, compared to baseline.<br>- Postprandial TG (AUC) change at the primary analysis time point from baseline as compared to placebo.<br>