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Study to evaLuate the effIcac...

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)

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-27

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrial Fibrillation (AF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Abelacimab (MAA868)

Patients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.

Group Type EXPERIMENTAL

Abelacimab

Intervention Type BIOLOGICAL

Abelacimab provided as liquid in vial (150 mg/mL)

Placebo

Patients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dosage Formulation: Liquid (in vial)

Dose Strength: Placebo to Abelacimab

Interventions

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Abelacimab

Abelacimab provided as liquid in vial (150 mg/mL)

Intervention Type BIOLOGICAL

Placebo

Dosage Formulation: Liquid (in vial)

Dose Strength: Placebo to Abelacimab

Intervention Type DRUG

Other Intervention Names

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MAA868

Eligibility Criteria

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Inclusion Criteria

* Patient is able to understand and has provided written informed consent to participate in the trial
* Diagnosed Atrial Fibrillation (AF) or atrial flutter (documented on an electrocardiogram (ECG) or monitor recording)
* Age 65-74 and a CHA2DS2VASc ≥4 OR age ≥75 and a CHA2DS2VASc ≥3
* Patient is judged by the responsible physician to be unsuitable for oral anticoagulation because the risks outweigh the benefits or the patient is unwilling to take oral anticoagulation AND this determination was made prior to and independent of the study
* At least 1 bleeding risk factor such as severe renal insufficiency, planned daily use of antiplatelet medication for the duration of the trial, history of bleeding from a critical area, or other conditions associated with increased risk of bleeding such as chronic nonsteroidal anti-inflammatory drug (NSAID) use, frailty or multiple falls
* Patient is judged by the responsible physician to be unsuitable for left atrial appendage (LAA) closure or occlusion device, an approved device is not available, or the patient is unwilling to undergo the procedure AND this determination was made prior to and independent of the study

Exclusion Criteria

* AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use)
* Patients who within 60 days prior to randomization (1) received a vitamin K antagonists (VKA) (e.g., warfarin, phenprocoumon, acenocoumarol) or a direct oral anticoagulant (DOAC) such as, dabigatran, rivaroxaban, apixaban, or edoxaban or (2) were newly diagnosed with AF
* Patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of spontaneous intracerebral hemorrhage at any time in the absence of antithrombotic treatment
* Any stroke within 14 days before randomization or transient ischemic attack (TIA) within 3 days before randomization
* Mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or invasive) during the course of the study
* Patients on dialysis at screening or who are planned to start dialysis within 6 months

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

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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