Acute Coronary SyndromesPhase 2FORTIFYNCT06927739
Focused Orticumab Research for Treating Inflammation in Coronary Arteries
A Phase 2 study testing Orticumab in people with Acute Coronary Syndromes and Coronary Arterial Disease (CAD), run by Abcentra at 41 sites in 9 countries.
Trial summary
The goal of this clinical trial is to determine the clinical effect of orticumab treatment on inflammation in study participants with prior myocardial infarction who have elevated coronary inflammation based on CCTA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndromes, Coronary Arterial Disease (CAD), Inflammation
- What is being tested?
- Orticumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 41 sitesin 9 countries
- Study dates
- 11 Aug 2025to 1 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must provide informed consent before any study specific activities are performed, must be able and willing to meet all requirements for randomization and must adhere to the schedules of activities.
- Participant must be >180 days after presumed type-1 myocardial infarction (i.e., due to plaque rupture or erosion, either STEMI or NSTEMI) without subsequent unstable or severe angina (Canadian Cardiovascular Society Class 3 or 4) at the time of enrollment. Participants who have undergone PCI are allowed.
- Participant must be on a stable cardiovascular treatment regimen consistent with local treatment guidelines for post-AMI patients (such as maximally tolerated statin and/or PCSK9 inhibitor medication for LDL reduction, antiplatelet medication, and hypertension treatment).
- Participant must have an evaluable, pre-randomization CCTA with one of the following:
- A quantifiable Fat Attenuation Index (FAI) Score greater than or equal to the 50th centile (per reference standard) for their age group in at least two coronary arteries or
- A quantifiable Fat Attenuation Index (FAI) Score greater than or equal to the 75th centile (per reference standard) for their age group in at least one coronary artery
Show all 13Show fewer
- Participant must have body mass index (BMI) ≤ 40 kg/m2.
- Adult male and female participants ≥18 years of age at the Screening Visit:
- For female participants, the participant must not be pregnant or lactating and must be one of the following:
- Postmenopausal, defined as amenorrhea for ≥ 12 months following cessation of all exogenous hormonal treatments; follicle stimulating hormone levels may be obtained at the investigator's discretion to confirm the participant is postmenopausal.
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered as irreversible surgical sterilization.
- Females of childbearing potential must have a negative serum or urine pregnancy test prior to the start of study drug. In the case of positive urine pregnancy testing, a negative serum sample for pregnancy testing, to confirm that the participant is not pregnant, must be obtained prior to start of study. They must also agree to use an adequate method of contraception from Baseline through the End of the study or for 30 days after the last dose of study drug (whichever is longer), which include the following: sexual abstinence (if preferred and usual lifestyle of the participant), condom with spermicidal gel, diaphragm with spermicidal gel, coil (intrauterine device), surgical sterilization, vasectomy, oral contraceptive pill, depo progesterone injections, progesterone implant (i.e., Implanon®), NuvaRing®, Ortho Evra®.
- For male participants - Nonsterile male participants with sexual partners of childbearing potential must agree to use an adequate method of contraception, including sexual abstinence (if preferred and usual lifestyle of the participant), from Baseline through the End of the study.
Who cannot join
- History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- Percutaneous coronary intervention or invasive diagnostic coronary angiogram planned after screening. Eligible participants who have an invasive diagnostic coronary angiogram performed in the absence of undergoing a new PCI may continue screening after the diagnostic angiogram has been performed or may be rescreened.
- History of or planned coronary artery bypass grafting.
- Documented episode of post-MI pericarditis in the 3 months before enrollment.
- Presence of unstable or uncontrolled angina. Canadian CV society (CCS) angina class > 2.
- Ongoing New York Heart Association Class IV HF.
Show all 40Show fewer
- Poorly controlled type 1 or type 2 diabetes mellitus (hemoglobin A1c >8.0%).
- Increased risk of bleeding:
- With history or presence of any bleeding disorder.
- Signs of ongoing bleeding at screening (e.g., identified macroscopic bleeding, low hemoglobin presumed to be caused by bleeding) or high risk for major bleeding in accordance with the Investigator's assessment (participants taking clinically indicated antiplatelet and antithrombotic agents are acceptable).
- Known severe liver disease (e.g., >5´ upper limit of normal elevations in ALT and/or AST and other evidence of grade 3 or higher criteria applies such as from the CTCAE 5.0 guidelines).
- History or presence of any of the following:
- Ongoing infection or febrile illness.
- Ongoing persistent or permanent atrial fibrillation or flutter.
- Cancer within 5 years before randomization, with the exception of non-melanoma skin cancer.
- Alcohol or substance abuse within 6 months before randomization, as judged by the investigator.
- Known history of hypersensitivity reactions to other biologics, to human IgG preparations, or to any component of orticumab, or ongoing severe allergy as judged by the investigator.
- Active positive results on screening for serum hepatitis C core antibody.
- Clinically documented hepatitis B or HIV.
- Any clinically important abnormalities in clinical chemistry, hematology, coagulation parameters, as judged by the investigator.
- Blood pressure values at screening (taken as the average of triplicate measurements):
- Systolic blood pressure < 90 mmHg or > 180 mmHg.
- Diastolic blood pressure > 100 mmHg.
- One triplicate retest (repeat of all 3) will be allowed during the same visit, at which point if the retest result is no longer exclusionary, the participant may be randomized
- Participants who are excluded based on elevated blood pressure may be rescreened following adequate treatment.
- Participants with any of the following contraindications to CCTA.
- eGFR < 40 mL/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration equation, or end stage renal disease treated with kidney transplant or renal replacement therapy.
- Allergy to iodinated contrast.
- History of contrast-induced nephropathy.
- Contraindication to nitroglycerin.
- Rapid heart rate that is uncontrolled by medical therapy.
- Inability to hold breath for at least 6 seconds.
- Use of any of the following in the 180 days before randomization: IL-17 inhibitor, TNF inhibitor, IL-6 inhibitor, IL-1β inhibitor, methotrexate, cyclosporine, apremilast, colchicine, systemic steroids (topical steroid use is allowed).
- COVID-19 vaccine within 90 days of screening CCTA.
- Participants with a confirmed positive COVID-19 test within 90 days of screening CCTA.
- Receipt of any investigational device or therapy within 6 months or 5 half-lives before screening (whichever is longer).
- Planned participation in an additional investigational study of an intervention or biologic before the end of the follow-up period. Participation in observational studies or studies without investigational drugs or devices is allowed.
- Participants who have previously been exposed to orticumab.
- Participants who are legally institutionalized.
- An employee or close relative of an employee of the sponsor, the CRO, or the study site, regardless of the employee or close relative's role.
Trial locations and contacts
41 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
41 sites in 9 countries
United States7 sites, 7 recruiting
- Recruiting
Abcentra Investigational Site
Baltimore, Maryland, 21215
- Recruiting
Abcentra Investigational Site
Boca Raton, Florida, 33434
- Not yet recruiting
Abcentra Investigational Site
Los Angeles, California, 90048
- Not yet recruiting
Abcentra Investigational Site
Louisville, Kentucky, 40202
- Recruiting
Abcentra Investigational Site
Midland, Michigan, 48670
- Recruiting
Abcentra Investigational Site
Richmond, Indiana, 47374
- Recruiting
Abcentra Investigational Site
Torrance, California, 90502
Czechia5 sites, 5 recruiting
- Recruiting
Abcentra Investigational Site
Brno, South Moravian, 602 00
- Recruiting
Abcentra Investigational Site
Ostrava, Moravian-Silesian Region, 728 80
- Recruiting
Abcentra Investigational Site
Pilsen, Plzeň Region, 323 00
- Recruiting
Abcentra Investigational Site
Prague, Praha 2, 128 08
- Recruiting
Abcentra Investigational Site
Prague, Praha 4, 140 21
Hungary5 sites, 5 recruiting
- Recruiting
Abcentra Investigational Site
Budapest, Central Hungary, 1036
- Recruiting
Abcentra Investigational Site
Budapest, Central Hungary, 1094
- Recruiting
Abcentra Investigational Site
Budapest, Central Hungary, 1132
- Recruiting
Abcentra Investigational Site
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400
- Recruiting
Abcentra Investigational Site
Pécs, Baranya, 7635
Italy5 sites, 5 recruiting
- Recruiting
Abcentra Investigational Site
Brescia, Lombardy, 25123
- Recruiting
Abcentra Investigational Site
Caserta, Campania, 81100
- Recruiting
Abcentra Investigational Site
Ferrara, Ferrara, 44124
- Recruiting
Abcentra Investigational Site
Milan, Lombardy, 20162
- Recruiting
Abcentra Investigational Site
Pavia, Lombardy, 27100
Spain5 sites, 5 recruiting
- Recruiting
Abcentra Investigational Site
Córdoba, Andalusia, 14004
- Recruiting
Abcentra Investigational Site
El Palmar, Murcia, 30120
- Recruiting
Abcentra Investigational Site
Madrid, Madrid, 28034
- Recruiting
Abcentra Investigational Site
Madrid, Madrid, 28046
- Recruiting
Abcentra Investigational Site
Seville, Sevilla, 41009
United Kingdom5 sites, 5 recruiting
- Recruiting
Abcentra Investigational Site
Bath, Somerset, BA1 3NG
- Recruiting
Abcentra Investigational Site
London, Greater London, EC1M 6BQ
- Recruiting
Abcentra Investigational Site
Manchester, Greater Manchester, M23 9LT
- Recruiting
Abcentra Investigational Site
Oxford, Oxfordshire, OX3 9DU
- Recruiting
Abcentra Investigational Site
Sheffield, South Yorkshire, S57AU
Poland3 sites, 3 recruiting
- Recruiting
Abcentra Investigational Site
Krakow, Lesser Poland Voivodeship, 30-082
- Recruiting
Abcentra Investigational Site
Warsaw, Masovian Voivodeship, 03-505
- Recruiting
Abcentra Investigational Site
Wroclaw, Lower Silesian Voivodeship, 50-556
Romania3 sites, 3 recruiting
- Recruiting
Abcentra Investigational Site
Baia Mare, Maramureş, 430031
- Recruiting
Abcentra Investigational Site
Târgu Mureş, Mureș County, 540124
- Recruiting
Abcentra Investigational Site
Timișoara, Timiș County, 300060
Sweden3 sites, 3 recruiting
- Recruiting
Abcentra Investigational Site
Danderyd, Stockholm County, 182 88
- Recruiting
Abcentra Investigational Site
Gothenburg, Västra Götaland County, 413 45
- Recruiting
Abcentra Investigational Site
Solna, Stockholm County, 171 76
About this study
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Orticumab in Participants With Prior Myocardial Infarction Who Have Elevated Coronary Inflammation Based on FAI Score Assessed by CCTA
The goal of this clinical trial is to determine the clinical effect of orticumab treatment on inflammation in study participants with prior myocardial infarction who have elevated coronary inflammation based on CCTA. The main question it aims to answer is:
Clinical effects of orticumab treatment on inflammation of the coronary artery parameters measured with CCTA
Read more
Researchers will compare the effects with placebo group after 6 months of treatment
Participants will Keep the planned study visit appointments Provide complete information about medical and medical history Speak to the study doctor before changing any of non-study treatments, including starting new medications, receiving any vaccinations, or setting out to join any other clinical studies
Read the detailed description
Participants will have the opportunity to participate in a Day 14 sub study. Participants who enroll in this optional sub study will have safety assessment (AE monitoring) and a blood sample obtained for serum orticumab concentration measurement, ADA titer, clinical safety labs and cardiometabolic and inflammation biomarkers.
- Conditions
- Acute Coronary Syndromes, Coronary Arterial Disease (CAD), Inflammation, Heart Disease, Myocardial Infarct, Atherosclerotic Coronary Vascular Disease
- Being tested
- Orticumab, Placebo
- Medical subject headings
- Acute Coronary Syndrome, Inflammation, Heart Diseases, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrticumabDrug
Also called MLDL1278a, BI204
Orticumab treatment for 24 weeks for post MI population
PlaceboDrug
Placebo for 24 weeks for the post MI population
| Study group | Role | What they receive |
|---|---|---|
| Orticumab High Dose | Active comparator | Not described Receives: Drug: Orticumab |
| Orticumab Low Dose | Active comparator | Not described Receives: Drug: Orticumab |
| Placebo High Dose | Placebo comparator | Not described Receives: Drug: Placebo |
| Placebo Low Dose | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline of the mean Fat Attenuation Index (FAI) score for the 3 coronary arteries (RCA, LAD and LCX) for orticumab compared to placebo at 24 weeks
Analysis of the mean FAI score around the coronary arteries will be performed from baseline and 6-month Coronary Computed Tomography Angiography (CCTA) procedures.
FAI-score is a standardized measurement of coronary inflammation for each coronary artery (adjusted for age, sex as well as technical, biological, and anatomical characteristics) to allow individualized interpretation of the degree of coronary inflammation. FAI-Score is given at a scale of 0-100 with arbitrary unit.
A higher FAI-score indicates an increase coronary inflammation.
Measured: 24 weeks
Secondary outcomes (2)
Change from baseline for coronary artery inflammation
Change from baseline for Fat Attenuation Index (FAI) parameters for orticumab compared to placebo after 24 weeks of treatment assessed by Coronary Computed Tomography Angiography (CCTA)
Measured: 24 weeks
Change from baseline for CaRi-Heart score for orticumab compared to placebo at 24 weeks of treatment
CaRi-Heart Risk score represents the individualized patient risk of a fatal cardiac event at 8 years which incorporates the FAI score values into a prognostic model that includes information about CCTA-derived plaque metrics and clinical cardiovascular risk factors (diabetes, smoking, hypertension, hyperlipidemia).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start11 Aug 2025
- Primary completion8 Feb 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abcentra
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927739
- Sponsor's protocol ID
- ORT-2024-02
- Acronym
- FORTIFY
- Status last verified
- Oct 2025
- First submitted
- 25 Mar 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Orticumab in Participants With Prior Myocardial Infarction Who Have Elevated Coronary Inflammation Based on FAI Score Assessed by CCTA
- ClinicalTrials.gov ID
- NCT06927739
- Acronym / sponsor ID
- FORTIFY / ORT-2024-02
- Conditions
- Acute Coronary Syndromes, Coronary Arterial Disease (CAD), Inflammation, Heart Disease, Myocardial Infarct, Atherosclerotic Coronary Vascular Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- AbcentraIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 8 Feb 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine the clinical effect of orticumab treatment on inflammation in study participants with prior myocardial infarction who have elevated coronary inflammation based on CCTA. The main question it aims to answer is:
Clinical effects of orticumab treatment on inflammation of the coronary artery parameters measured with CCTA
Researchers will compare the effects with placebo group after 6 months of treatment
Participants will Keep the planned study visit appointments Provide complete information about medical and medical history Speak to the study doctor before changing any of non-study treatments, including starting new medications, receiving any vaccinations, or setting out to join any other clinical studies
Detailed description
Participants will have the opportunity to participate in a Day 14 sub study. Participants who enroll in this optional sub study will have safety assessment (AE monitoring) and a blood sample obtained for serum orticumab concentration measurement, ADA titer, clinical safety labs and cardiometabolic and inflammation biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Orticumab High Dose | Active comparator | Drug: Orticumab |
| Orticumab Low Dose | Active comparator | Drug: Orticumab |
| Placebo High Dose | Placebo comparator | Drug: Placebo |
| Placebo Low Dose | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participant must provide informed consent before any study specific activities are performed, must be able and willing to meet all requirements for randomization and must adhere to the schedules of activities.
- Participant must be >180 days after presumed type-1 myocardial infarction (i.e., due to plaque rupture or erosion, either STEMI or NSTEMI) without subsequent unstable or severe angina (Canadian Cardiovascular Society Class 3 or 4) at the time of enrollment. Participants who have undergone PCI are allowed.
- Participant must be on a stable cardiovascular treatment regimen consistent with local treatment guidelines for post-AMI patients (such as maximally tolerated statin and/or PCSK9 inhibitor medication for LDL reduction, antiplatelet medication, and hypertension treatment).
- Participant must have an evaluable, pre-randomization CCTA with one of the following:
- Participant must have body mass index (BMI) ≤ 40 kg/m2.
Key exclusion criteria (40 listed)
- History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- Percutaneous coronary intervention or invasive diagnostic coronary angiogram planned after screening. Eligible participants who have an invasive diagnostic coronary angiogram performed in the absence of undergoing a new PCI may continue screening after the diagnostic angiogram has been performed or may be rescreened.
- History of or planned coronary artery bypass grafting.
- Documented episode of post-MI pericarditis in the 3 months before enrollment.
- Presence of unstable or uncontrolled angina. Canadian CV society (CCS) angina class > 2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrticumabAlso: MLDL1278a, BI204Orticumab treatment for 24 weeks for post MI population | Drug | Orticumab High Dose, Orticumab Low Dose |
| PlaceboPlacebo for 24 weeks for the post MI population | Drug | Placebo High Dose, Placebo Low Dose |
Primary outcome
Percent change from baseline of the mean Fat Attenuation Index (FAI) score for the 3 coronary arteries (RCA, LAD and LCX) for orticumab compared to placebo at 24 weeks
Time frame: 24 weeks
Analysis of the mean FAI score around the coronary arteries will be performed from baseline and 6-month Coronary Computed Tomography Angiography (CCTA) procedures. FAI-score is a standardized measurement of coronary inflammation for each coronary artery (adjusted for age, sex as well as technical, biological, and anatomical characteristics) to allow individualized interpretation of the degree of coronary inflammation. FAI-Score is given at a scale of 0-100 with arbitrary unit. A higher FAI-score indicates an increase coronary inflammation.
2 secondary outcomes
Change from baseline for coronary artery inflammation
Time frame: 24 weeks
Change from baseline for CaRi-Heart score for orticumab compared to placebo at 24 weeks of treatment
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
41 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Orticumab in people with Acute Coronary Syndromes and Coronary Arterial Disease (CAD), run by Abcentra at 41 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Czechia, Hungary, Italy, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abcentra (424-369-4401, info@abcentra.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline of the mean Fat Attenuation Index (FAI) score for the 3 coronary arteries (RCA, LAD and LCX) for orticumab compared to placebo at 24 weeks (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.