Clinical trial

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

Recruiting now · Phase 3 · 2 countries · Registry ID NCT07567001

Recruiting nowPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity, Heart Failure

Full registry 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.

Treatments and study arms

NNC0487-0111

Drug

NNC0487-011 will be administered subcutaneously.

Placebo

Drug

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

Primary outcomes

Time to first occurrence of a composite Heart Failure (HF) endpoint consisting of cardiovascular (CV) deathFrom baseline (week 0) to 165 weeks

Measured in days.

Time to first occurrence of a composite HF endpoint consisting of HF hospitalisation or urgent HF visitFrom baseline (week 0) to 165 weeks

Measured in days.

Study locations

838 locations were listed when this page was built. The first 40 are shown.

Cardiología Hospital J. M. Ramos Mejia🇦🇷 Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli🇦🇷 Buenos Aires, Argentina
Fundación Respirar🇦🇷 Buenos Aires, Argentina
CEDIC Centro de Investigación Clínica🇦🇷 CABA, Argentina
CEMEDIC🇦🇷 CABA, Buenos Aires, Argentina
Glenny Corp. S.A🇦🇷 CABA, Argentina
Centro de Investigaciones Metabólicas🇦🇷 Capital Federal, Buenos Aires, Argentina
Cardiología Palermo🇦🇷 City of Buenos Aires, Buenos Aires, Argentina
CardiaMet🇦🇷 Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Centro Médico Luquez🇦🇷 Córdoba, Argentina
Clínica Privada Velez Sarsfield🇦🇷 Córdoba, Argentina
Instituto de Investigaciones Clínicas Córdoba🇦🇷 Córdoba, Argentina
Sanatorio Esperanza🇦🇷 Esperanza, Santa Fe, Argentina
Hospital Español de Mendoza🇦🇷 Godoy Cruz, Mendoza, Mendoza Province, Argentina
Centro Medico Capital🇦🇷 La Plata, Buenos Aires, Argentina
Centro Médico CIMEL🇦🇷 Lanús Este, Buenos Aires, Argentina
Hospital Universitario Austral - Instituto de Cardiologia🇦🇷 Pilar, Buenos Aires, Argentina
CAICI🇦🇷 Rosario, Argentina
INECO Neurociencias Oroño🇦🇷 Rosario, Santa Fe Province, Argentina
Instituto Especialidades de la Salud Rosario🇦🇷 Rosario, Santa Fe Province, Argentina
Instituto de Investigaciones Clínicas Rosario🇦🇷 Rosario, Santa Fe Province, Argentina
Centro Cardiovascular Salta🇦🇷 Salta, Argentina
CMC Cardiología Sociedad Simple🇦🇷 San Miguel de Tucumán, Argentina
Instituto de Investigaciones de Patologías Respiratorias🇦🇷 San Miguel de Tucumán, Argentina
Instituto de Investigaciones Clinicas San Nicolás🇦🇷 San Nicolás, Argentina
CEDIR - Centro de diagnóstico y rehabilitación Santa Fe🇦🇷 Santa Fe, Argentina
Centro de Investigaciones Clinica Baigorria🇦🇷 Santa Fe, Argentina
Centro de investigaciones Clinicas del Litoral🇦🇷 Santa Fe, Argentina
MIT Medicina, Investigación y tratamiento🇦🇷 Santa Rosa, La Pampa, Argentina
Nightingale Research Adelaide🇦🇺 Adelaide, South Australia, Australia
Flinders Medical Centre - Cardiology Department🇦🇺 Bedford Park, South Australia, Australia
Canberra Hospital - Clinical Trials Unit🇦🇺 Canberra, Australian Capital Territory, Australia
Heart of Australia🇦🇺 Chelmer, Queensland, Australia
The Prince Charles Hospital - Cardiology Clinical Research Centre🇦🇺 Chermside, Queensland, Australia
Lyell McEwin Hospital - Clinical Trials Unit🇦🇺 Elizabeth Vale, South Australia, Australia
Nightingale Research Victoria🇦🇺 Frankston, Victoria, Australia
Adrian Costa Clinical Trials Centre🇦🇺 Geelong, Victoria, Australia
Royal Hobart Hospital - Cardiology Department🇦🇺 Hobart, Tasmania, Australia
Baker-HeartWest - Hoppers Crossing🇦🇺 Hoppers Crossing, Victoria, Australia
Life Clinical Research🇦🇺 Ipswich, Queensland, Australia