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NCT07567001ClinicalTrials.gov

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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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…

Fase 35610 partecipanti ricercati838 centri27 paesi

Categorie

Cardiovascolare71%Endocrino e metabolico29%

Registrato in 1 registro

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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2026-05-05; recorded start 2026-05-11
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 333 other studies in this databaseCounted from the lead sponsor named in the record (Novo Nordisk A/S)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 2 conditions.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding20/20

    Quadruple-blind

  • Control arm13/15

    Placebo / sham control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type10/10

    Mortality / MACE endpoint (hard clinical outcome)

  • Multi-centre8/8

    Multi-centre: 839 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 5,610 participants (target), run at 838 sites, across 27 countries.

How this score is built
  • Enrolment36/40

    5,610 participants (target)

  • Site count25/25

    839 sites

  • Country count15/15

    27 countries

  • Planned duration8/10

    Planned over about 40 months

  • Sponsor scale9/10

    Novo Nordisk A/S has led 320 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Sintesi

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.

Patologie

  • Obesity
  • Heart Failure

Idoneità

SessoTutti
Età18 Years – Nessun massimo
Volontari saniNo

Idoneità come riportata nel registro

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.

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioInterventistico
FaseFase 3
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoQUADRUPLE (4)
Arruolamento5610 partecipanti ricercati

Sponsor e collaboratori

  • Novo Nordisk A/S Sponsor

Bracci e interventi

  • NNC0487-0111EXPERIMENTAL

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

  • PlaceboPLACEBO_COMPARATOR

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

Interventi

  • Farmaco NNC0487-0111

    NNC0487-011 will be administered subcutaneously.

  • Farmaco Placebo

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

Esiti misurati

  1. Esito primario

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

    Measured in days.

    Orizzonte temporale From baseline (week 0) to 165 weeks

  2. Esito primario

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

    Measured in days.

    Orizzonte temporale From baseline (week 0) to 165 weeks

  3. Esito secondario

    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

    Measured in days.

    Orizzonte temporale From baseline (week 0) to 165 weeks

  4. Esito secondario

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

    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.

    Orizzonte temporale From baseline (week 0) to week 52

  5. Esito secondario

    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)

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

    Orizzonte temporale From baseline (week 0) to week 78

  6. Esito secondario

    Time to all-cause death

    Measured in days.

    Orizzonte temporale From baseline (week 0) to 165 weeks

Date

Data di inizio11 maggio 2026 (effettiva)
Conclusione primaria23 luglio 2029 (stimata)
Conclusione15 agosto 2029 (stimata)
Prima pubblicazione5 maggio 2026 (effettiva)
Ultimo aggiornamento18 agosto 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltaagosto 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

530 centri stanno reclutando

Argentina

StrutturaCittàStato o regioneStato
Cardiología Hospital J. M. Ramos MejiaBuenos AiresNon ancora in reclutamento
Fundación RespirarBuenos AiresIn reclutamento
Centro Medico Dra. Laura Maffei e Investigacion Clínica ApliBuenos AiresIn reclutamento
CEDIC Centro de Investigación ClínicaCABANon ancora in reclutamento
Glenny Corp. S.ACABAIn reclutamento
CEMEDICCABABuenos AiresIn reclutamento
Centro de Investigaciones MetabólicasCapital FederalBuenos AiresIn reclutamento
Cardiología PalermoCity of Buenos AiresBuenos AiresIn reclutamento
CardiaMetCiudad Autonoma de Buenos AiresBuenos AiresIn reclutamento
Clínica Privada Velez SarsfieldCórdobaIn reclutamento
Centro Médico LuquezCórdobaIn reclutamento
Instituto de Investigaciones Clínicas CórdobaCórdobaIn reclutamento
Sanatorio EsperanzaEsperanza, Santa FeIn reclutamento
Hospital Español de MendozaGodoy Cruz, MendozaMendoza ProvinceIn reclutamento
Centro Medico CapitalLa Plata, Buenos AiresIn reclutamento
Centro Médico CIMELLanús EsteBuenos AiresIn reclutamento
Hospital Universitario Austral - Instituto de CardiologiaPilarBuenos AiresIn reclutamento
Instituto Especialidades de la Salud RosarioRosarioSanta Fe ProvinceIn reclutamento
INECO Neurociencias OroñoRosarioSanta Fe ProvinceIn reclutamento
CAICIRosarioIn reclutamento
Instituto de Investigaciones Clínicas RosarioRosarioSanta Fe ProvinceIn reclutamento
Centro Cardiovascular SaltaSaltaNon ancora in reclutamento
Instituto de Investigaciones de Patologías RespiratoriasSan Miguel de TucumánIn reclutamento
CMC Cardiología Sociedad SimpleSan Miguel de TucumánIn reclutamento
Instituto de Investigaciones Clinicas San NicolásSan NicolásIn reclutamento
CEDIR - Centro de diagnóstico y rehabilitación Santa FeSanta FeIn reclutamento
Centro de Investigaciones Clinica BaigorriaSanta FeIn reclutamento
Centro de investigaciones Clinicas del LitoralSanta FeIn reclutamento
MIT Medicina, Investigación y tratamientoSanta Rosa, La PampaIn reclutamento

Australia

StrutturaCittàStato o regioneStato
Nightingale Research AdelaideAdelaideSouth AustraliaIn reclutamento
Flinders Medical Centre - Cardiology DepartmentBedford ParkSouth AustraliaNon ancora in reclutamento
Canberra Hospital - Clinical Trials UnitCanberraAustralian Capital TerritoryNon ancora in reclutamento
Heart of AustraliaChelmerQueenslandIn reclutamento
The Prince Charles Hospital - Cardiology Clinical Research CentreChermsideQueenslandIn reclutamento
Lyell McEwin Hospital - Clinical Trials UnitElizabeth ValeSouth AustraliaIn reclutamento
Nightingale Research VictoriaFrankstonVictoriaIn reclutamento
Adrian Costa Clinical Trials CentreGeelongVictoriaIn reclutamento
Royal Hobart Hospital - Cardiology DepartmentHobartTasmaniaIn reclutamento
Baker-HeartWest - Hoppers CrossingHoppers CrossingVictoriaIn reclutamento
Life Clinical ResearchIpswichQueenslandIn reclutamento
Advara HeartCare JoondalupJoondalupWestern AustraliaIn reclutamento
Advara HeartCare LeabrookLeabrookSouth AustraliaIn reclutamento
Sydney Cardiometabolic CentreLiverpoolNew South WalesIn reclutamento
Core Research GroupMiltonQueenslandIn reclutamento
Advara HeartCare MulgraveMulgraveVictoriaIn reclutamento

Brazil

StrutturaCittàStato o regioneStato
Jmf Clínica Do Coração LtdaAracajuIn reclutamento
CCIH-Consultoria em Controle de Infecção Hospitalar LtdaBelo HorizonteMinas GeraisIn reclutamento
Grupo AngioKormannBlumenauSanta CatarinaNon ancora in reclutamento
Associação Lar São Francisco de Assis na Providência de Deus - Bragança PaulistaBragança PaulistaSão PauloIn reclutamento
Synvia Laboratorios E Toxicologia LtdaCampinasSão PauloIn reclutamento

Nella scheda del registro sono indicati altri 788 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

  1. 18 agosto 2026

    Centro rimosso

    1 site removed (838 total)

    839838

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07567001