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)

Study acronym: LILAC-TIMI 76

StatusRecruiting

PhasePhase 3

SponsorAnthos Therapeutics, Inc.

Started2022-12-27

View on ClinicalTrials.gov ↗

Trial flagged as At Risk

Primary completion moved at least 15 months later Aug 31, 2026 → Dec 30, 2027

See other at-risk trials from Anthos Therapeutics, Inc.

Amendment history

The 50 most recent of 64 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-07-10

Study Status, Study Description, Study Design, Outcome Measures, Contacts/Locations v63

Enrollment increased: 1900 → 2500 participants

Trial sites expanded: 734 → 789 locations

Primary completion pushed: 2026-08-31 → 2027-12-30

Completion pushed: 2026-10-31 → 2027-12-30

Study description+729 characters

Patients enrolled in the study are randomized in a 1:1 ratio to receive abelacimab 150 mg SC or matching placebo once monthly. The study is comprised of 3 periods: 1) screening period of up to 60 days, 2) an event-driven, double-blind treatment period (abelacimab 150 mg SC or matching placebo) compl [...]

2026-03-27

Study Status, Contacts/Locations v62

Trial sites expanded: 721 → 734 locations

2026-02-12

Study Status, Contacts/Locations v61

Study sites681→721

2026-01-16

Study Identification, Study Status, Contacts/Locations v60

Study sites651→681

2025-11-17

Study Status, Sponsor/Collaborators, Oversight, Contacts/Locations, IPDSharing v59

Primary completion date2026-08→2026-08-31

Completion date2026-10→2026-10-31

Study sites605→651

Collaborators+24 characters

Novartis Pharmaceuticals

Show 45 earlier versions

2025-09-18

Study Status, Contacts/Locations v58

Study sites599→605

2025-09-09

Study Status, Contacts/Locations v57

Study sites578→599

2025-08-21

Study Status, Contacts/Locations v56

Study sites565→578

2025-08-11

Study Status, Contacts/Locations v55

Study sites553→565

2025-07-25

Study Status, Oversight, Contacts/Locations v54

Study sites545→553

2025-07-17

Study Status, Oversight, Contacts/Locations v53

Study sites531→545

2025-06-25

Study Status, Contacts/Locations v52

Study sites516→531

2025-06-10

Study Status, Contacts/Locations v51

Study sites480→516

2025-05-16

Study Status, Oversight, Contacts/Locations v50

Study sites473→480

2025-05-01

Study Status, Oversight, Contacts/Locations v49

Study sites468→473

2025-04-15

Study Identification, Study Status, Contacts/Locations v48

Study sites460→468

Study titlerevised

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

2025-03-21

Study Status, Contacts/Locations v47

Study sites451→460

2025-02-26

Study Identification, Study Status, Oversight, Contacts/Locations v46

Study sites446→451

Study titlerevised

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

2025-02-10

Study Status, Contacts/Locations v45

Study sites438→446

2025-01-21

Study Identification, Study Status, Oversight, Contacts/Locations v44

Study sites435→438

Study titlerevised

2025-01-13

Study Status, Contacts/Locations v43

Study sites427→435

2024-12-20

Study Status, Contacts/Locations v42

Study sites420→427

2024-12-09

Study Status, Contacts/Locations v41

Study sites416→420

2024-11-22

Study Status, Contacts/Locations v40

Study sites411→416

2024-11-07

Study Status, Contacts/Locations v39

Study sites407→411

2024-10-17

Study Identification, Study Status, Oversight, Contacts/Locations v38

Study sites400→407

Study titlerevised

2024-10-04

Study Status, Contacts/Locations v37

Primary completion date2025-01→2026-08

Completion date2025-03→2026-10

Study sites394→400

2024-09-19

Study Status, Contacts/Locations v36

Study sites391→394

2024-09-09

Study Status, Eligibility, Contacts/Locations v35

Study sites389→391

Eligibility criteria+87 characters

[...] ntion (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

2024-08-20

Study Status, Contacts/Locations v34

Study sites386→389

2024-08-06

Study Status, Contacts/Locations v33

Study sites380→386

2024-07-15

Study Status, Contacts/Locations v32

Study sites373→380

2024-07-02

Study Status, Contacts/Locations v31

Study sites367→373

2024-06-18

Study Status, Contacts/Locations v30

Study sites364→367

2024-05-31

Study Status, Contacts/Locations v29

Study sites359→364

2024-05-24

Study Status, Contacts/Locations v28

Study sites354→359

2024-05-12

Study Identification, Study Status, Eligibility, Contacts/Locations v27

Study sites339→354

Eligibility criteria+586 characters

Inclusion Criteria: Patient is able to understand and ~~willing~~has ~~to provide~~provided written informed consent to participate in the trial Diagno [...] am (ECG) or monitor recording) Age 65-74 and a CHA2DS2VASc ≥54 OR age ≥75 and a CHA2DS2VASc ≥43 ~~Judged~~Patient is judged by the responsible physician ~~or by their own decision~~ 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 insuff [...] ti-inflammatory [...]

2024-04-16

Study Status, Contacts/Locations v26

Study sites332→339

2024-03-28

Study Status, Contacts/Locations v25

Study sites320→332

2024-03-19

Study Status, Contacts/Locations v24

Study sites309→320

2024-03-04

Study Status, Contacts/Locations v23

Study sites300→309

2024-02-18

Study Status, Contacts/Locations v22

Study sites284→300

2024-02-05

Study Status, Contacts/Locations v21

Study sites275→284

2024-01-11

Study Status, Contacts/Locations v20

Study sites257→275

2024-01-04

Study Status, Contacts/Locations v19

Study sites240→257

2023-12-14

Study Status, Contacts/Locations v18

Study sites217→240

2023-12-04

Study Status, Contacts/Locations v17

Study sites163→217

2023-11-17

Study Status, Contacts/Locations v16

Study sites122→163

2023-11-09

Study Status, Contacts/Locations v15

Re-verified, no change to tracked fields

2023-11-06

Study Status, Contacts/Locations v14

Study sites108→122

Anthos Therapeutics, Inc.

4 trials monitored

See 1 trial at risk

Atrial Fibrillation

1,126 trials monitored

See 49 trials at risk

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.

Trial Details

NCT Number	NCT05712200
Lead Sponsor	Anthos Therapeutics, Inc. Collaborators: Novartis Pharmaceuticals
Conditions	Atrial Fibrillation (AF)
Enrollment	2,500 participants
Start Date	2022-12-27
Primary Completion	2027-12-30 (estimated)
Study Completion	2027-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-13