BridgeMD
A Phase 3 Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults with Familial Chylomicronemia Syndrome
EU CTIS ID: 2024-514336-24-00
What this study is testing
The objectives of the study are to evaluate the efficacy and safety of ARO-APOC3 in adults with FCS
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men and nonpregnant women, ≥18 years of age (or ≥19 years of age, where applicable according to the local regulation)
- Fasting TG ≥10 mmol/L (≥880 mg/dL) that is refractory to standard lipid-lowering therapy
- Diagnosis of FCS
You likely can't join if
- Recent use of any hepatocyte-targeted siRNA or antisense oligonucleotide molecule
- Active pancreatitis
- Elevated ALT or AST (≥3×ULN)
- Elevated total bilirubin (≥1.5×ULN)
- Glycated hemoglobin (HbA1c) ≥9.0% (or ≥75 mmol/mol International Federation of Clinical Chemistry [IFCC] units) or glomerular filtration rate <30 mL/min/1.73 m2
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Korea, Republic of
- Japan
- Argentina
- United States
- Oman
- Mexico
- Serbia
- Singapore
- Turkey
- Israel
- Canada
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Korea, Republic of; Japan; Argentina; United States; Oman and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.