RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will get NNC0487-0111 or placebo by injection once a week."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety and effects of NNC0487-0111 in people with obesity and heart failure whose heart pumping strength is normal or mildly reduced. Participants get a weekly shot of the study medicine or a placebo, which has no active medicine, chosen by chance. The study medicine is not yet available by prescription.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a body mass index (BMI), a measure of weight compared with height, of 30 or higher at screening.
  • Have stable heart failure in NYHA class II–IV, meaning symptoms with activity or at rest, as judged by the study doctor.
  • If you have type 2 diabetes, it must have been diagnosed at least 30 days before screening.

Who can't join

  • Had a heart attack, stroke, unstable chest pain, or worsening heart failure needing a hospital stay or water-removing medicine through a vein within 30 days before screening or between screening and treatment assignment.
  • Have heart failure caused by certain heart muscle diseases, active heart muscle swelling, a stiff heart lining, fluid pressing on the heart, or an uncorrected moderate or severe heart valve problem.
  • Have severe lung disease, including high blood pressure in the lung arteries or long-term blood clots in the lungs.
  • Have severe COPD, a long-term lung disease, that requires oxygen at home or ongoing steroid pills, or caused a hospital stay for a flare-up in the 12 months before screening.
  • Have another condition that the study doctor thinks causes your heart failure symptoms, such as low red blood cells or an underactive thyroid.
  • Have a history of type 1 diabetes.
  • Have diabetes-related eye damage treated with laser treatment, eye surgery, or anti-VEGF medicine within 180 days before screening, or likely to need this treatment within 180 days after screening. An eye exam must check for this damage.
  • Have an HbA1c, a blood test showing average blood sugar, above 10% at screening.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (206)

AL

AR

AZ

CA

CO

DC

FL

GA

HI

IA

ID

IL

IN

KS

KY

LA

MD

ME

MI

MO

MS

NC

NE

NJ

NV

NY

OH

OR

PA

SC

SD

TN

TX

UT

VA

WA

WI

WV