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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

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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…

Phase 35 610 participants recherchés838 sites27 pays

Catégories

Cardiovasculaire71%Endocrinien et métabolique29%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

  • Obesity
  • Heart Failure

Éligibilité

SexeTous
Âges18 Years – Aucun maximum
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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.

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 3
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuQUADRUPLE (4)
Recrutement5 610 participants recherchés

Promoteur et collaborateurs

  • Novo Nordisk A/S Promoteur

Groupes et interventions

  • 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.

Interventions

  • Médicament NNC0487-0111

    NNC0487-011 will be administered subcutaneously.

  • Médicament Placebo

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

Critères de jugement

  1. Critère de jugement principal

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

    Measured in days.

    Délai From baseline (week 0) to 165 weeks

  2. Critère de jugement principal

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

    Measured in days.

    Délai From baseline (week 0) to 165 weeks

  3. Critère de jugement secondaire

    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.

    Délai From baseline (week 0) to 165 weeks

  4. Critère de jugement secondaire

    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.

    Délai From baseline (week 0) to week 52

  5. Critère de jugement secondaire

    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.

    Délai From baseline (week 0) to week 78

  6. Critère de jugement secondaire

    Time to all-cause death

    Measured in days.

    Délai From baseline (week 0) to 165 weeks

Dates

Date de début11 mai 2026 (réelle)
Achèvement principal23 juillet 2029 (estimée)
Achèvement15 août 2029 (estimée)
Première publication5 mai 2026 (réelle)
Dernière mise à jour18 août 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisaoût 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

530 sites sont en recrutement

Argentina

ÉtablissementVilleÉtat ou régionStatut
Cardiología Hospital J. M. Ramos MejiaBuenos AiresPas encore en recrutement
Fundación RespirarBuenos AiresEn recrutement
Centro Medico Dra. Laura Maffei e Investigacion Clínica ApliBuenos AiresEn recrutement
CEDIC Centro de Investigación ClínicaCABAPas encore en recrutement
Glenny Corp. S.ACABAEn recrutement
CEMEDICCABABuenos AiresEn recrutement
Centro de Investigaciones MetabólicasCapital FederalBuenos AiresEn recrutement
Cardiología PalermoCity of Buenos AiresBuenos AiresEn recrutement
CardiaMetCiudad Autonoma de Buenos AiresBuenos AiresEn recrutement
Clínica Privada Velez SarsfieldCórdobaEn recrutement
Centro Médico LuquezCórdobaEn recrutement
Instituto de Investigaciones Clínicas CórdobaCórdobaEn recrutement
Sanatorio EsperanzaEsperanza, Santa FeEn recrutement
Hospital Español de MendozaGodoy Cruz, MendozaMendoza ProvinceEn recrutement
Centro Medico CapitalLa Plata, Buenos AiresEn recrutement
Centro Médico CIMELLanús EsteBuenos AiresEn recrutement
Hospital Universitario Austral - Instituto de CardiologiaPilarBuenos AiresEn recrutement
Instituto Especialidades de la Salud RosarioRosarioSanta Fe ProvinceEn recrutement
INECO Neurociencias OroñoRosarioSanta Fe ProvinceEn recrutement
CAICIRosarioEn recrutement
Instituto de Investigaciones Clínicas RosarioRosarioSanta Fe ProvinceEn recrutement
Centro Cardiovascular SaltaSaltaPas encore en recrutement
Instituto de Investigaciones de Patologías RespiratoriasSan Miguel de TucumánEn recrutement
CMC Cardiología Sociedad SimpleSan Miguel de TucumánEn recrutement
Instituto de Investigaciones Clinicas San NicolásSan NicolásEn recrutement
CEDIR - Centro de diagnóstico y rehabilitación Santa FeSanta FeEn recrutement
Centro de Investigaciones Clinica BaigorriaSanta FeEn recrutement
Centro de investigaciones Clinicas del LitoralSanta FeEn recrutement
MIT Medicina, Investigación y tratamientoSanta Rosa, La PampaEn recrutement

Australia

ÉtablissementVilleÉtat ou régionStatut
Nightingale Research AdelaideAdelaideSouth AustraliaEn recrutement
Flinders Medical Centre - Cardiology DepartmentBedford ParkSouth AustraliaPas encore en recrutement
Canberra Hospital - Clinical Trials UnitCanberraAustralian Capital TerritoryPas encore en recrutement
Heart of AustraliaChelmerQueenslandEn recrutement
The Prince Charles Hospital - Cardiology Clinical Research CentreChermsideQueenslandEn recrutement
Lyell McEwin Hospital - Clinical Trials UnitElizabeth ValeSouth AustraliaEn recrutement
Nightingale Research VictoriaFrankstonVictoriaEn recrutement
Adrian Costa Clinical Trials CentreGeelongVictoriaEn recrutement
Royal Hobart Hospital - Cardiology DepartmentHobartTasmaniaEn recrutement
Baker-HeartWest - Hoppers CrossingHoppers CrossingVictoriaEn recrutement
Life Clinical ResearchIpswichQueenslandEn recrutement
Advara HeartCare JoondalupJoondalupWestern AustraliaEn recrutement
Advara HeartCare LeabrookLeabrookSouth AustraliaEn recrutement
Sydney Cardiometabolic CentreLiverpoolNew South WalesEn recrutement
Core Research GroupMiltonQueenslandEn recrutement
Advara HeartCare MulgraveMulgraveVictoriaEn recrutement

Brazil

ÉtablissementVilleÉtat ou régionStatut
Jmf Clínica Do Coração LtdaAracajuEn recrutement
CCIH-Consultoria em Controle de Infecção Hospitalar LtdaBelo HorizonteMinas GeraisEn recrutement
Grupo AngioKormannBlumenauSanta CatarinaPas encore en recrutement
Associação Lar São Francisco de Assis na Providência de Deus - Bragança PaulistaBragança PaulistaSão PauloEn recrutement
Synvia Laboratorios E Toxicologia LtdaCampinasSão PauloEn recrutement

788 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 18 août 2026

    Site retiré

    1 site removed (838 total)

    839838

Registre: ClinicalTrials.gov · NCT########

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