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

Recruiting

• Conditions: Atrial Fibrillation (AF)
• Interventions: Biological: Abelacimab; Drug: Placebo

• Registration Number: NCT05712200
• Lead Sponsor: Anthos Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-27
• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-25
• Study First Posted: 2023-02-03
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-17
• Last Update Posted: 2025-07-20
• Primary Completion: 2026-08
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1900

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

Other protocol defined Inclusion/Exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abelacimab (MAA868)	Abelacimab	Patients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.
Placebo	Placebo	Patients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.

Primary Outcome Measures

Name	Time	Method
Safety: Time to first occurrence of Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding	Up to 30 months
Efficacy: Time to first event of ischemic stroke or systemic embolism (SE)	Up to 30 months

Secondary Outcome Measures

Name	Time	Method
Efficacy: All-cause mortality	Up to 30 months
Efficacy: Cardiovascular (CV) mortality	Up to 30 months
Efficacy: Time to first event of ischemic stroke, systemic embolism (SE), or Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding event	Up to 30 months
Efficacy: Time to first event of ischemic stroke, systemic embolism (SE), myocardial infarctions (MI), venous thromboembolism (VTE), or acute limb ischemia	Up to 30 months	Abelacimab versus placebo with regard to the composite of ischemic stroke, SE, MI, VTE, or acute limb ischemia
Time to first event of ischemic stroke, systemic embolism (SE), myocardial infarctions (MI), venous thromboembolism (VTE), acute limb ischemia, or International Society on Thrombosis and Haemostasis (ISTH) major bleeding	Up to 30 months	Abelacimab versus placebo with regard to net clinical outcome defined as the composite of ischemic stroke, SE, MI, VTE, acute limb ischemia, or International Society on Thrombosis and Haemostasis (ISTH) major bleeding

Trial Locations

Locations (545)

Anthos Investigative Site 1040; 🇺🇸 Birmingham, Alabama, United States

Anthos Investigative Site 1041; 🇺🇸 Mobile, Alabama, United States

Anthos Investigative Site 1089; 🇺🇸 Gilbert, Arizona, United States

Anthos Investigative Site 1099; 🇺🇸 Peoria, Arizona, United States

Anthos Investigative Site 9906; 🇺🇸 Phoenix, Arizona, United States

Anthos Investigative Site 9927; 🇺🇸 Yuma, Arizona, United States

Anthos Investigative Site 9929; 🇺🇸 Huntington Beach, California, United States

Anthos Investigative Site 9921; 🇺🇸 Lancaster, California, United States

Anthos Investigative Site 1078; 🇺🇸 Loma Linda, California, United States

Anthos Investigative Site 1077; 🇺🇸 Los Angeles, California, United States

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