Efficacy and Safety of NNC0487-0111 Compared to Placebo on Morbidity and Mortality in People With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity

Registration

Registration

NCT07567001

Acronym

HF-POLARIS

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE3

Masking

QUADRUPLE

Status

RECRUITING

Enrollment

5610

Start

2026-05-11

Primary completion

2029-07-23

Lead sponsor

Novo Nordisk A/S

Conditions

Obesity; Heart Failure

Interventions

DRUG:NNC0487-0111; DRUG:Placebo

Results posted

FALSE

Individual participant data sharing

YES

Secondary identifiers

OTHER:U1111-1328-2701; OTHER:2025-523717-29; NIH:2025

Registered primary outcomes

• Time to first occurrence of a composite Heart Failure (HF) endpoint consisting of cardiovascular (CV) death [From baseline (week 0) to 165 weeks]
• Time to first occurrence of a composite HF endpoint consisting of HF hospitalisation or urgent HF visit [From baseline (week 0) to 165 weeks]