Recruiting NCT07567001

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

Phase III Interventional Obesity Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: NNC0487-0111, Placebo.
Who it may be relevant to: Registry conditions: Obesity, Heart Failure. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Brazil, Bulgaria +22
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Drug NNC0487-0111
NNC0487-011 will be administered subcutaneously.
Drug Placebo
Placebo (matched to NNC0487-011) will be administered subcutaneously.

Primary outcome measures

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]
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]

Secondary outcome measures (4)

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]
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]
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 millilitre per minute per 1.73 square metre (mL/min/1.73 m^2) [Time frame: From baseline (week 0) to week 78]
Time to all-cause death [Time frame: From baseline (week 0) to 165 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment