A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity

Study acronym: HF-POLARIS
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Study sites: 839 to 838
    • Secondary endpoints revised (4)
    v4
  2. Study sites: 838 to 839v3
  3. Recruitment opened
    • Trial sites expanded: 825 → 838 locations
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Novo Nordisk
269 trials monitored
See 14 trials at risk
Heart Disease
8,862 trials monitored
See 438 trials at risk
Obesity
3,903 trials monitored
See 160 trials at risk
Heart Failure
2,014 trials monitored
See 120 trials at risk
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.
Trial Details
NCT Number NCT07567001
Lead Sponsor Novo Nordisk A/S
Conditions
(from sponsor)		 Obesity, Heart Failure
Related terms Heart Failure, Obesity
Enrollment 5,610 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov