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Looking for participantsPhase3

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)

Sponsor: Anthos Therapeutics, Inc.

NCT ID: NCT05712200

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Abelacimab (biological), Placebo (drug)
How long the study runs
Study runs about 60 months (dates as stated)
About the drug or intervention
Abelacimab — biological: Abelacimab provided as liquid in vial (150 mg/mL) · Placebo — drug: Dosage Formulation: Liquid (in vial) Dose Strength: Placebo to Abelacimab
Patient visit burden
Not specified by the sponsor

In plain English

This study, called LILAC-TIMI 76 and funded by Anthos Therapeutics, Inc., is testing how well and how safely a medicine called abelacimab works in people with atrial fibrillation (an irregular heartbeat) who are at high risk and cannot take, or do not want to take, blood-thinning tablets. It focuses on people who are unsuitable for standard oral anticoagulation (blood-thinning) medicines.

Who can take part

  • You can give written informed consent and understand the trial
  • You have been diagnosed with atrial fibrillation or atrial flutter (shown on a heart tracing or monitor)
  • You are aged 65-74 with a CHA2DS2-VASc score of 4 or more (a score measuring stroke risk), or aged 75 or over with a score of 3 or more
  • Your doctor has decided, before the study, that blood-thinning tablets are not suitable for you or you are unwilling to take them
  • You have at least one bleeding risk factor, such as severe kidney problems, planned daily antiplatelet medicine, past bleeding in a critical area, regular use of anti-inflammatory painkillers (NSAIDs), frailty or frequent falls
  • Your doctor has decided you are unsuitable for a left atrial appendage closure device (a small device fitted in the heart), it is not available, or you are unwilling to have the procedure

Who may not be able to

  • Your atrial fibrillation is caused by a short-term treatable problem, such as recent heart surgery, a blood clot in the lungs, an overactive thyroid, or alcohol use
  • You took blood-thinning tablets (such as warfarin, dabigatran, rivaroxaban, apixaban or edoxaban) in the 60 days before joining, or your atrial fibrillation was newly diagnosed in that time
  • You had bleeding in the brain or eye in the 3 months before screening, or have ever had a brain bleed without blood-thinning treatment
  • You had a stroke in the 14 days before joining or a mini-stroke (TIA) in the 3 days before joining
  • You have a mechanical heart valve or heart valve disease expected to need a mechanical valve replacement during the study
  • You are on dialysis or due to start dialysis within 6 months
  • Other criteria in the study plan may also apply

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team about visits, duration and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
65 Years and over
Who
All
Number of participants
2,500
Started
2022-12-27
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for atrial fibrillation (af)
  • • Phase3 - 2,500 participants
  • • 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

Who can take part?

  • • Ages 65 Years and over
  • • Diagnosed with atrial fibrillation (af)

Where?

  • • Bollington - Anthos Investigational site 1327
  • • Blackpool - Anthos Investigational site 1329
  • • Brierley Hill - Anthos Investigational site 1328
  • • Corby - Anthos Investigative Site 1303
  • • +25 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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) completed after at least 111 patients have experienced an adjudicated primary endpoint event, and 3) EoT visit in core part followed by either (i) a 30-day follow-up period (EoS for core part) OR (ii) an optional OLE beginning at the EoT visit for eligible patients to receive open-label abelacimab treatment. The optional extension will only be offered to patients following regulatory and ethics approval in participating countries.

Atrial Fibrillation (AF)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 65 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Patient is able to understand and has provided written agreement to take part 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

Who cannot take part

  • ✗AF due to an ongoing acute reversible cause (e.g., heart surgery, lung embolism (PE), untreated...
  • ✗Patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of...
  • ✗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...
  • ✗Patients on dialysis at screening or who are planned to start dialysis within 6 months
See the full 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 Is This Study? (29 UK sites)

Anthos Investigational site 1327

Bollington SK105JH, United Kingdom

Recruiting

Anthos Investigational site 1329

Blackpool FY3 8NR, United Kingdom

Recruiting

Anthos Investigational site 1328

Brierley Hill DY5 1RU, United Kingdom

Recruiting

Anthos Investigative Site 1303

Corby NN17 2UR, United Kingdom

WITHDRAWN

Anthos Investigative Site 1313

Glasgow G20 0XA, United Kingdom

WITHDRAWN

Anthos Investigative Site 1320

Glasgow G51 4TF, United Kingdom

Recruiting

Anthos Investigative Site 1315

Hayle TR27 5DT, United Kingdom

Recruiting

Anthos Investigative Site 1311

High Wycombe HP11 2TT, United Kingdom

Recruiting

Anthos Investigative Site 1301

Isleworth TW7 6AF, United Kingdom

Recruiting

Anthos Investigative Site 1316

Kings Lynn PE30 4ET, United Kingdom

Recruiting

Anthos Investigative Site 1324

Lancaster LA1 4ZP, United Kingdom

Recruiting

Anthos Investigative Site 1322

Larbert FK5 4WR, United Kingdom

WITHDRAWN

Anthos Investigative Site 1309

Leeds LS1 3EX, United Kingdom

Recruiting

Anthos Investigative Site 1325

Liverpool L14 3PE, United Kingdom

Recruiting

Anthos Investigative Site 1314

London IG1 4HP, United Kingdom

WITHDRAWN

Anthos Investigative Site 1319

London NW1 5DH, United Kingdom

Recruiting

Anthos Investigative Site 1326

London NW10 2PT, United Kingdom

Recruiting

Anthos Investigative Site 1308

London SW3 6NP, United Kingdom

Recruiting

Anthos Investigative Site 1323

Luton LU4 0DZ, United Kingdom

Recruiting

Anthos Investigative Site 1312

Manchester M27 8FF, United Kingdom

Recruiting

Anthos Investigative Site 1307

Newcastle upon Tyne NE7 7DN, United Kingdom

WITHDRAWN

Anthos Investigative Site 1318

Norwich NR2 2TJ, United Kingdom

Recruiting

Anthos Investigational site 1330

Oxford OX3 9JA, United Kingdom

Recruiting

Anthos Investigative Site 1305

Peterborough PE3 9GZ, United Kingdom

Recruiting

Anthos Investigative Site 1321

Romford RM7 0AG, United Kingdom

Recruiting

Anthos Investigative Site 1302

Stevenage SG1 4AB, United Kingdom

Recruiting

Anthos Investigative Site 1310

Stockton-on-Tees TS19 8PE, United Kingdom

Recruiting

Anthos Investigative Site 1317

Stoke-on-Trent ST4 6QG, United Kingdom

Recruiting

Anthos Investigative Site 1306

Taunton TA1 5DA, United Kingdom

WITHDRAWN

How to Get in Touch

Anthos Therapeutics a Novartis Company

Sponsor contact

CONTACT

1-888-669-6682 novartis.email@novartis.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07