Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ziltivekimab B · 2 trials · 4 indications
Months
Measured in day\*microgram per milliliter (day\*μg/mL).
| Arm | Type | Description |
|---|---|---|
| Ziltivekimab | EXPERIMENTAL | Participants will receive Ziltivekimab B or Ziltivekimab C subcutaneously once monthly for up to 4 years. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive either placebo (Ziltivekimab B) or placebo (Ziltivekimab C) subcutaneously once monthly for up to 4 years. |
| Ziltivekimab B (manual syringe) | EXPERIMENTAL | Participants will receive a single subcutaneous (s.c.) injection of 15 milligram (mg) ziltivekimab B (15 milligrams per milliliter \[mg/mL\]) by single-use pre-filled manual syringe on Day 1. |
| Ziltivekimab D (manual syringe) | EXPERIMENTAL | Participants will receive a single s.c. injection of 15 mg ziltivekimab D (15 mg/mL) by single-use pre-filled manual syringe on Day 1. |
| Ziltivekimab C (pen-injector) | EXPERIMENTAL | Participants will receive a single s.c. injection of 15 mg ziltivekimab C (30 mg/mL) by single-use pre-filled syringe assembled into a shield-activated pen-injector on Day 1. |
| Name | Type | Description |
|---|---|---|
| Ziltivekimab B | DRUG | Administered subcutaneously (s.c., under skin) once-monthly added to standard of care. |
| Ziltivekimab C | DRUG | Administered subcutaneously (s.c., under skin) once-monthly added to standard of care. |
| Placebo (Ziltivekimab B) | DRUG | Administered subcutaneously (s.c., under skin) once-monthly added to standard of care. |
| Placebo (Ziltivekimab C) | DRUG | Administered subcutaneously (s.c., under skin) once-monthly added to standard of care. |
| Ziltivekimab D | DRUG | Participants will receive a single s.c. injection of 15 mg ziltivekimab D (15 mg/mL) by single-use pre-filled manual syringe on Day 1. |
Inclusion Criteria: * Chronic kidney disease defined by one of the below: 1. Estimated glomerular filtration rate (eGFR) greater than or equal to (\>=) 15 and below 60 mL/min/1.73 m\^2 (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation) 2. Urinary albumi...
Ziltivekimab B is an investigational drug being studied for cardiovascular risk in people with cardiovascular disease, chronic kidney disease, and inflammation. It is also being studied in healthy participants to assess blood levels of different formulations. The drug is in Phase 3 clinical development and is not yet approved.
Ziltivekimab B is a small molecule being developed for cardiovascular risk. Its specific molecular target is not disclosed in the available information. The drug is being studied in patients with cardiovascular disease, chronic kidney disease, and inflammation to evaluate its effects compared to placebo.
Ziltivekimab B is being developed by Novo Nordisk A/S, a biopharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in cardiovascular risk and healthy participants.
Ziltivekimab B is in Phase 3 clinical development. The drug is investigational and has not been approved by regulatory authorities. It is being studied in a completed Phase 3 trial for cardiovascular risk and a completed Phase 1 trial in healthy participants.
Ziltivekimab B has been studied in two completed trials. NCT05021835, a Phase 3 study called ZEUS, enrolled 6,385 participants with cardiovascular disease, chronic kidney disease, and inflammation. NCT05721989, a Phase 1 study, enrolled 267 healthy participants to evaluate blood levels of different formulations.
Ziltivekimab B is a formulation of the study medicine ziltivekimab. The Phase 1 trial NCT05721989 investigated blood levels of three different formulations of ziltivekimab, including Ziltivekimab B. The drug is being developed by Novo Nordisk for cardiovascular risk.