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Evaluating abelacimab for patients with atrial fibrillation unsuitable for oral anticoagulation

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)

Phase 3 Interventional Anthos Therapeutics, Inc. · NCT05712200

This study is testing a new medication called abelacimab to see if it can help people with atrial fibrillation who can't take blood thinners avoid strokes.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1900 (estimated)
Ages65 Years and up
SexAll
SponsorAnthos Therapeutics, Inc. Industry-sponsored
Drugs / interventionsabelacimab
Locations734 sites (Birmingham, Alabama and 733 other locations)
Trial IDNCT05712200 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of abelacimab compared to a placebo in high-risk patients with atrial fibrillation who are deemed unsuitable for oral anticoagulation therapy. It focuses on the rate of ischemic stroke or systemic embolism in this specific patient population. Participants must meet certain age and health criteria, including a CHA2DS2VASc score indicating a high risk for stroke. The study is designed as a randomized, double-blind, placebo-controlled trial to ensure reliable results.

Who should consider this trial

Good fit: Ideal candidates are patients aged 65-74 with a CHA2DS2VASc score of 4 or higher, or those aged 75 and older with a score of 3 or higher, who are deemed unsuitable for oral anticoagulation.

Not a fit: Patients who are suitable for oral anticoagulation therapy or do not have atrial fibrillation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer alternative for high-risk patients with atrial fibrillation who cannot take traditional anticoagulants.

How similar studies have performed: Other studies have shown promise in using novel anticoagulants for patients with atrial fibrillation, but this specific approach with abelacimab is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Other protocol defined Inclusion/Exclusion criteria may apply

Where this trial is running

Birmingham, Alabama and 733 other locations

+684 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atrial Fibrillationabelacimabrandomizedplacebo-controlleddouble-blindendpoint evaluationatrial fibrillation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.