Atrial Fibrillation (AF)Phase 3LILAC-TIMI 76NCT07739888
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 study testing Abelacimab in people with Atrial Fibrillation (AF), run by Novartis Pharmaceuticals.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Abelacimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2027to 30 Dec 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- Patients meeting any exclusion criteria in the core part.
- Patients who have a history or evidence of any clinically significant disorder, condition, or disease that in the investigator's opinion or Sponsor physician (if consulted), would put the participant at risk or interfere with the study participation
- History of hypersensitivity to the study drug or its excipients, to drugs of similar chemical classes
- Any medical or psychiatric condition which in the judgment of the Investigator either requires urgent medical intervention/hospitalization or may preclude patients from complying with study requirements for the duration of the study.
- Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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)
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)
Read the 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.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Abelacimab
- Keywords
- abelacimab, randomized, placebo-controlled, double-blind, endpoint evaluation, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbelacimabBiological
Also called MAA868
Abelacimab provided as liquid in vial (150 mg/mL)
| Study group | Role | What they receive |
|---|---|---|
| Abelacimab (MAA868) | Experimental | abelacimab 150 mg subcutaneous (SC) Receives: Biological: Abelacimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first ISTH major Bleeding events
Time to first International Society on Thrombosis and Haemostasis (ISTH) major bleeding events
Measured: Up to 3 years
Time to first BARC type 3c/5 bleeding
Time to first Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding
Measured: Up to 3 years
Number of participants with ISTH major or CRNM bleeding
Number of participants with International Society on Thrombosis and Haemostasis (ISTH) major or clinically relevant non-major (CRNM) bleeding
Measured: Up to 3 years
Number of participants with bleeding
All suspected bleeding events either reported by the patient or observed by the Investigator
Measured: Up to 3 years
Number of participants with TEAEs and TESAEs
Number of participants with treatment emergent AEs (TEAEs) and treatment emergent SAEs (TESAEs)
Measured: Up to 3 years
Number of participants with treatment discontinuations due to TEAEs
Number of participants with treatment discontinuations due to treatment emergent AEs (TEAEs)
Measured: Up to 3 years
Number of participants with device related AEs, SAEs, and device deficiencies
Measured: Up to 3 years
Secondary outcomes (1)
Time to first event of ischemic stroke or SE
Time to first event of ischemic stroke or systemic embolism (SE). Undetermined strokes will be counted as ischemic strokes
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start30 Dec 2027 (estimated)
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739888
- Sponsor's protocol ID
- ANT-010_OLE
- Other IDs
- 2023-503224-66-00, 2023
- Acronym
- LILAC-TIMI 76
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com