NNC0487-0111 for Obesity and Heart Failure

(HF-POLARIS Trial)

Not yet recruiting at 824 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novo Nordisk A/S

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is being done to look at the safety and effect of NNC0487-0111 in people with Heart Failure with preserved Ejection Fraction (HFpEF) or Heart Failure with mildly reduced Ejection Fraction (HFmrEF) and excess body weight when compared to placebo. The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have HFpEF or HFmrEF and excess body weight. Participants will get NNC0487-0111 or placebo by injection once a week. Which treatment participants get is decided by chance. NNC0487-0111 is a new medicine that doctors cannot prescribe yet, but it has been tested in people before.

Who Is on the Research Team?

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

Inclusion Criteria

Body Mass Index (BMI) greater than or equal to (">=") 30 kilograms per square metre (kg/m^2) at screening.

I have heart failure (NYHA class II-IV) and my condition is stable.

I was diagnosed with Type 2 Diabetes at least 30 days ago.

Exclusion Criteria

History of type 1 diabetes.

Glycated haemoglobin (HbA1c) greater than (">") 10 percent (%) (86 [millimoles per mole] mmol/mol) as measured by local or central laboratory at screening.

My heart failure is not caused by rare heart muscle or valve diseases.

What Are the Treatments Tested in This Trial?

Interventions

• NNC0487-0111

How Is the Trial Designed?

Group I: NNC0487-0111 Experimental Treatment 1 Intervention

Participants will receive NNC0487-0111 subcutaneously (s.c.) in a dose escalating manner once weekly.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo matched to NNC0487-011 s.c. once weekly.

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen