A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation

Conditions

• Heart Failure

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ziltivekimab — DRUG
  Ziltivekimab subcutaneous (s.c.) injection in a pre-filled syringe or a pen-injector once-monthly for up to 4 years.
• Placebo — DRUG
  Ziltivekimab placebo s.c. injection in a pre-filled syringe or a pen-injector once-monthly for up to 4 years.

Study Details

This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.

Key Dates

Start date

May 8, 2023

Status verified

Mar 2026

Primary completion

Jul 2, 2027

Completion

Jul 2, 2027

Study Design

Enrollment

5,600 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ziltivekimab
  Participants will receive ziltivekimab subcutaneous (s.c.) injection once-monthly and added standard of care for up to 4 years.
• Placebo Comparator: Placebo
  Participants will receive ziltivekimab placebo s.c. injection once-monthly and added standard of care for up to 4 years.

Primary Outcome Measure

Time to First Occurrence of a Composite Heart Failure Endpoint Consisting of: Cardiovascular (CV) Death, Heart Failure (HF) Hospitalisation or Urgent HF Visit [ Time Frame: From randomisation (month 0) to end of study (up to 48 months) ]

Central Contacts

• Novo Nordisk
  (+1) 866-867-7178
  [email protected]

Locations (184)

Find similar trials in Alexander City, AL

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