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Trial · Interventional

RecruitingPhase 3Registry data

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

Short name HF-POLARIS

NCTNCT07567001 (opens ClinicalTrials.gov in a new tab)Other idNN9490-8266Other idU1111-1328-2701Other id2025-523717-29Other id2025

Overview

Status
Recruiting
Phase
Phase 3
Enrollment
5,610 participants (estimated)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
27 countries

United States, Argentina, Australia, Brazil, Bulgaria, Canada, China, Czechia, Denmark, France, Germany, Greece, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Puerto Rico, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Start
11 May 2026
Primary completion
23 Jul 2029 (estimated)
Completion
15 Aug 2029 (estimated)
First posted
5 May 2026
Last update posted
18 Aug 2026
Conditions
Obesity · Heart Failure

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20262027202820292030
  1. Ph 3

    HF-POLARIS

    NCT07567001

    11 May 2026 to est. 15 Aug 2029

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • NNC0487-0111Drug
  • PlaceboDrug

Arms2

  • Experimental

    NNC0487-0111

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

  • Placebo comparator

    Placebo

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

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Time to first occurrence of a composite Heart Failure (HF) endpoint consisting of cardiovascular (CV) death

    Time frame · From baseline (week 0) to 165 weeks

    Registry description

    Measured in days.

  2. Time to first occurrence of a composite HF endpoint consisting of HF hospitalisation or urgent HF visit

    Time frame · From baseline (week 0) to 165 weeks

    Registry description

    Measured in days.

Secondary outcomes(4)
  1. Time to first occurrence of a composite HF and Major Adverse Cardiovascular Events (MACE) end-point consisting of: CV death, HF hospitalisation or urgent HF visit, Nonfatal Myocardial Infraction (MI), Nonfatal stroke

    Time frame · From baseline (week 0) to 165 weeks

    Registry description

    Measured in days.

  2. Change in Clinical Summary Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-CSS) for participants with baseline KCCQ-CSS score less than (<) 80 points

    Time frame · From baseline (week 0) to week 52

    Registry description

    Measured as score on scale. KCCQ measures Health-Related Quality of Life (HRQOL). Score ranges from 0 to 100, with 0 as the lowest score and 100 as the highest score. Higher scores indicate better health status, fewer symptoms and greater disease-specific HRQoL.

  3. Change in estimated Glomerular Filtration Rate (eGFR) (creatinine and cystatin C-based Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] 2021) for participants with baseline eGFR< 60 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2)

    Time frame · From baseline (week 0) to week 78

    Registry description

    Measured as mL/min/1.73 m\^2.

  4. Time to all-cause death

    Time frame · From baseline (week 0) to 165 weeks

    Registry description

    Measured in days.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Body Mass Index (BMI) greater than or equal to (\>=) 30 kilograms per square metre (kg/m\^2) at screening. * Diagnosis of HF with New York Heart Association (NYHA) class II-IV and in stable condition at screening, at the discretion of the investigator. For participants with Type 2 Diabetes (T2D) at screening: \- Diagnosed with T2D \>= 30 days before screening. Exclusion Criteria: * MI, stroke, unstable angina pectoris or worsening HF leading to either hospitalization or intravenous loop diuretics within 30 days prior to the day of screening and until randomization. * HF due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, Chagas cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, or uncorrected primary valve disease of moderate or severe degree. * Severe pulmonary disease including primary pulmonary hypertension, chronic pulmonary embolism, or severe chronic obstructive pulmonary disease (COPD) defined as: * requiring home oxygen; or - ongoing oral corticosteroid therapy; or - hospital for COPD Exacerbation within 12 months prior to screening. * Any other condition judged by the investigator to be the cause of HF symptoms (e.g., anaemia, hypothyroidism). Glycaemia-related: * History of type 1 diabetes. * Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or who, at the time of screening, are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * Glycated haemoglobin (HbA1c) greater than (\>) 10 percent (%) (86 \[millimoles per mole\] mmol/mol) as measured by local or central laboratory at screening.

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