Study to Evaluate the effIcacy and Safety of Abelacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed 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)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07739888

Acronym

LILAC-TIMI 76

Enrollment

2500

Registered

2026-07-31

Start date

2027-12-30

Completion date

2030-12-30

Last updated

2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF)

Keywords

abelacimab, randomized, placebo-controlled, double-blind, endpoint evaluation, atrial fibrillation

Brief summary

This OLE part is an optional, single arm, multicenter, open-label extension (OLE) added to the core part to assess the long-term safety, tolerability, the incidence of ischemic stroke or SE and bleeding events of abelacimab in eligible patients who completed the double-blinded core part of CMAA868A2302 (ANT-010/NCT05712200)

Detailed description

Patients who provide consent, will need to complete the end of treatment visit (EoT) assessments of the Core Part of CMAA868A2302 (ANT-010/NCT05712200) prior to receiving first dose in the OLE. Day 1 visit or dosing should occur on same day as EoT visit to avoid treatment interruption. Participation in OLE will end if a patient permanently discontinues study treatment, or the study is completed or terminated by the Sponsor. All patients will need to complete End of Study in Extension visit in person followed by a phone call visit 30 days after End of Extension visit. Any updates in AE or concomitant medications will be reported by a phone call/video call visit.

Interventions

BIOLOGICALAbelacimab

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients are able to provide written informed consent to enter the extension part. * Patients must be on study treatment at the time of EoT visit in the core part.

Exclusion criteria

* Patients meeting any

Design outcomes

Primary

Measure	Time frame	Description
Time to first ISTH major Bleeding events	Up to 3 years	Time to first International Society on Thrombosis and Haemostasis (ISTH) major bleeding events
Time to first BARC type 3c/5 bleeding	Up to 3 years	Time to first Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding
Number of participants with ISTH major or CRNM bleeding	Up to 3 years	Number of participants with International Society on Thrombosis and Haemostasis (ISTH) major or clinically relevant non-major (CRNM) bleeding
Number of participants with bleeding	Up to 3 years	All suspected bleeding events either reported by the patient or observed by the Investigator
Number of participants with TEAEs and TESAEs	Up to 3 years	Number of participants with treatment emergent AEs (TEAEs) and treatment emergent SAEs (TESAEs)
Number of participants with treatment discontinuations due to TEAEs	Up to 3 years	Number of participants with treatment discontinuations due to treatment emergent AEs (TEAEs)
Number of participants with device related AEs, SAEs, and device deficiencies	Up to 3 years	—

Secondary

Measure	Time frame	Description
Time to first event of ischemic stroke or SE	Up to 3 years	Time to first event of ischemic stroke or systemic embolism (SE). Undetermined strokes will be counted as ischemic strokes

Contacts

CONTACTAnthos Therapeutics a Novartis Company

novartis.email@novartis.com1-888-669-6682

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026