NCT05712200

Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,900 (estimated)
• Sponsor: Anthos Therapeutics, Inc. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism (SE) in patients with Atrial Fibrillation (AF) who have been deemed by their responsible physicians or by their own decision to be unsuitable for oral anticoagulation therapy.

Conditions

• Atrial Fibrillation (AF)

Interventions

Type	Name	Description
BIOLOGICAL	Abelacimab	Abelacimab provided as liquid in vial (150 mg/mL)
DRUG	Placebo	Dosage Formulation: Liquid (in vial) Dose Strength: Placebo to Abelacimab

Timeline

• Start date: 2022-12-27
• Primary completion: 2026-08-31
• Completion: 2026-10-31
• First posted: 2023-02-03
• Last updated: 2026-03-31

Locations

734 sites across 34 countries: United States, Argentina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Estonia, Finland, Germany, Greece, Hungary, India, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Peru, Philippines, Poland, Romania, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study