Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as COR-001
Ziltivekimab · 8 trials · 12 indications
Change in percent atheroma volume (PAV) as determined by greyscale intravascular ultrasound (IVUS) in matched regions of interest. Theoretical change is between -100% to +100%. Typical range around -2% to +2%. A lower (more negative) change in PAV is better.
Percentage (%).
Measured in months.
Measured as score (score on scale; range; 0-100). The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
Percent change in hs-CRP levels from baseline (average of the hs-CRP value prior to the administration of study drug) to the end of treatment (average of Week 10 and Week 12) is presented. Baseline was defined as the average of all hs-CRP values prior to the first administration of study drug at day 1 and end of treatment was defined as the average of hs-CRP values at week 10 and week 12.
Percent change from baseline in hs-CRP levels at week 13 are presented.
Nanograms per millilitre\*days (ng/mL\*days)
The MTD assessment was based on safety data. If more than 2 of 8 active participants in a cohort experience a Dose-Limiting Toxicities (DLT), the MTD was considered to have been exceeded. The DLT threshold was defined using a threshold of greater than or equal to (\>=) Grade 3 events, which includes severe: infusion-related reactions, cardiopulmonary infusion reactions, anaphylaxis, or hypersensitivity. DLTs are defined as follows: 1. Confirmed Grade 3 neutropenia and representing a decline of \> 25% from baseline 2. Serious adverse events (SAEs) of infection in the presence of confirmed Grade 2 or higher new onset lymphopenia or new onset neutropenia. 3. ≥ Grade 3 ALT (Alanine transaminase) or AST(Aspartate transaminase) 4. ≥ Grade 4 hematologic toxicity 5. ≥ Grade 3 non-hematologic toxicity
Change from the baseline in hsCRP values to week 4 are presented.
Change from the baseline in serum amyloid A (SAA) values to week 4 are presented.
| Arm | Type | Description |
|---|---|---|
| Ziltivekimab Arm | EXPERIMENTAL | Participants will receive Ziltivekimab subcutaneously once per month |
| Placebo Arm | PLACEBO_COMPARATOR | Participants will receive placebo subcutaneously once per month |
| Ziltivekimab dose level 1 + standard of care (SOC) | EXPERIMENTAL | Participants receive dose level 1 of ziltivekimab along with standard of care (SOC) subcutaneously once monthly for 12 months. |
| Placebo + SOC | PLACEBO_COMPARATOR | Participants receive a placebo along with standard of care (SOC) subcutaneously once monthly for 12 months. |
| Ziltivekimab | EXPERIMENTAL | Participants will receive an initial loading dose of ziltivekimab Dose 1 subcutaneously (s.c.) as early as possible after invasive procedure, and latest within 36 hours of hospitalisation for ST-elevation myocardial infarction (STEMI) and within 48 hours of hospitalisation for non-ST-elevation myocardial infarction (NSTEMI), followed by ziltivekimab Dose 2 s.c. once-monthly during the treatment period (estimated up to 2 years) added to standard of care. |
| Placebo ziltivekimab | EXPERIMENTAL | Participants will receive placebo matched to ziltivekimab at an initial loading dose subcutaneously (s.c.) as early as possible after invasive procedure, and latest within 36 hours of hospitalisation for STEMI and latest within 48 hours of hospitalisation for NSTEMI, followed by placebo matched to ziltivekimab s.c. once-monthly during the treatment period (estimated up to 2 years) added to standard of care. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to ziltivekimab administered s.c. once-monthly and added to standard of care for 12 months. |
| Ziltivekimab 15 mg | EXPERIMENTAL | Participants will receive ziltivekimab 15 mg for 12 weeks. |
| Ziltivekimab 30 mg | EXPERIMENTAL | Participants will receive ziltivekimab 30 mg for 12 weeks. |
| Placebo (ziltivekimab) | PLACEBO_COMPARATOR | Participants will receive placebo (ziltivekimab) for 12 weeks. |
| Ziltivekimab 7.5 mg | EXPERIMENTAL | - |
| COR-001 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Ziltivekimab | DRUG | Ziltivekimab is administered subcutaneously (i.e., under the skin) once per month added to standard of care. |
| Placebo | DRUG | Placebo is administered subcutaneously (i.e., under the skin) once per month added to standard of care. |
| Ziltivekimab Placebo | DRUG | Participants will receive placebo matched to ziltivekimab subcutaneously. |
| Placebo (ziltivekimab) | DRUG | Administered s.c. once every 4 weeks for 12 weeks |
| COR-001 | DRUG | - |
Key Inclusion Criteria: * Informed consent obtained before any study-related activities. * Age 18 years or above at the time of providing informed consent. * Acute myocardial infarction, with at least one coronary segment (culprit lesion) treated with PCI. * At least two major native coronary arter...
Top 4 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| BridgeBio Pharma, Inc. | BBIO | 2 | PHASE3 | Acoramidis |
| Kiniksa Pharmaceuticals International, plc Class A | KNSA | 1 | PHASE2 | KPL-387 |
| AstraZeneca PLC | AZN | 3 | PHASE1 | AZD1705 |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX310 |
Ziltivekimab is an investigational monoclonal antibody developed by Novo Nordisk A/S. It is being studied in Phase 3 clinical trials for cardiovascular conditions, including cardiovascular risk, chronic kidney disease, coronary artery disease, heart failure, and myocardial infarction. It is not yet approved for any indication.
Ziltivekimab targets interleukin-6 (IL6) and acts as an inhibitor of this target. By binding to and inhibiting IL6, a cytokine involved in systemic inflammation, ziltivekimab is designed to reduce inflammatory signaling. This mechanism is being evaluated in cardiovascular and chronic kidney disease settings where inflammation is thought to play a role.
Ziltivekimab is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor of the Phase 3 clinical program evaluating the drug across cardiovascular and chronic kidney disease indications.
Ziltivekimab is in Phase 3 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA or any other regulatory agency for any indication. The Phase 3 program includes randomized, double-blind, controlled trials across multiple cardiovascular and kidney-related conditions.
Ziltivekimab is being studied in several Phase 3 trials. These include NCT07301034 and NCT07276282 in myocardial infarction and coronary artery disease, NCT06200207 in heart failure with systemic inflammation, and NCT06118281, known as ARTEMIS, in cardiovascular risk and acute myocardial infarction. The ARTEMIS trial has an enrollment of 10,000 participants.
Ziltivekimab is being investigated for cardiovascular risk reduction, chronic kidney disease, chronic kidney disease with systemic inflammation, coronary artery disease, heart failure, and myocardial infarction. These are investigational uses in Phase 3 trials, and the drug has not received approval for any indication.