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

RecruitingTaking participants now, according to the registry record.

Contact this study

In brief

Phase 35,610 participants sought838 sites27 countries

Registered in 1 registry

ClinicalTrials.govNCT07567001Open this record at ClinicalTrials.govSynced last month

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Trial information is shown as published by the registry, in its original language.

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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.

Present: Registered before enrolment beganFirst posted 2026-05-05; recorded start 2026-05-11
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: 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.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 333 other studies in this databaseCounted from the lead sponsor named in the record (Novo Nordisk A/S)
Present: 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.

Summary

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.

Conditions

Obesity
Heart Failure

Eligibility

Eligibility
Sex	All
Ages	18 Years – No maximum
Healthy volunteers	No

Eligibility as written in the registry

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.

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Phase 3
Allocation	Randomised
Intervention model	PARALLEL
Primary purpose	TREATMENT
Masking	QUADRUPLE (4)
Enrolment	5,610 participants sought

Sponsor and collaborators

Novo Nordisk A/S Sponsor

Arms and 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

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

Outcome measures

Primary outcome
Time to first occurrence of a composite Heart Failure (HF) endpoint consisting of cardiovascular (CV) death
Measured in days.
Time frame From baseline (week 0) to 165 weeks
Primary outcome
Time to first occurrence of a composite HF endpoint consisting of HF hospitalisation or urgent HF visit
Measured in days.
Time frame From baseline (week 0) to 165 weeks
Secondary outcome
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.
Time frame From baseline (week 0) to 165 weeks
Secondary outcome
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.
Time frame From baseline (week 0) to week 52
Secondary outcome
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.
Time frame From baseline (week 0) to week 78
Secondary outcome
Time to all-cause death
Measured in days.
Time frame From baseline (week 0) to 165 weeks

Dates

Dates
Start date	May 11, 2026 (actual)
Primary completion	July 23, 2029 (estimated)
Completion	August 15, 2029 (estimated)
First posted	May 5, 2026 (actual)
Last updated	August 18, 2026
Results posted	Not stated in the registry record
Status last verified	August 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

530 sites are recruiting

Argentina

Argentina
Facility	City	State or region	Status
Cardiología Hospital J. M. Ramos Mejia	Buenos Aires		Not yet recruiting
Fundación Respirar	Buenos Aires		Recruiting
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli	Buenos Aires		Recruiting
CEDIC Centro de Investigación Clínica	CABA		Not yet recruiting
Glenny Corp. S.A	CABA		Recruiting
CEMEDIC	CABA	Buenos Aires	Recruiting
Centro de Investigaciones Metabólicas	Capital Federal	Buenos Aires	Recruiting
Cardiología Palermo	City of Buenos Aires	Buenos Aires	Recruiting
CardiaMet	Ciudad Autonoma de Buenos Aires	Buenos Aires	Recruiting
Clínica Privada Velez Sarsfield	Córdoba		Recruiting
Centro Médico Luquez	Córdoba		Recruiting
Instituto de Investigaciones Clínicas Córdoba	Córdoba		Recruiting
Sanatorio Esperanza	Esperanza, Santa Fe		Recruiting
Hospital Español de Mendoza	Godoy Cruz, Mendoza	Mendoza Province	Recruiting
Centro Medico Capital	La Plata, Buenos Aires		Recruiting
Centro Médico CIMEL	Lanús Este	Buenos Aires	Recruiting
Hospital Universitario Austral - Instituto de Cardiologia	Pilar	Buenos Aires	Recruiting
Instituto Especialidades de la Salud Rosario	Rosario	Santa Fe Province	Recruiting
INECO Neurociencias Oroño	Rosario	Santa Fe Province	Recruiting
CAICI	Rosario		Recruiting
Instituto de Investigaciones Clínicas Rosario	Rosario	Santa Fe Province	Recruiting
Centro Cardiovascular Salta	Salta		Not yet recruiting
Instituto de Investigaciones de Patologías Respiratorias	San Miguel de Tucumán		Recruiting
CMC Cardiología Sociedad Simple	San Miguel de Tucumán		Recruiting
Instituto de Investigaciones Clinicas San Nicolás	San Nicolás		Recruiting
CEDIR - Centro de diagnóstico y rehabilitación Santa Fe	Santa Fe		Recruiting
Centro de Investigaciones Clinica Baigorria	Santa Fe		Recruiting
Centro de investigaciones Clinicas del Litoral	Santa Fe		Recruiting
MIT Medicina, Investigación y tratamiento	Santa Rosa, La Pampa		Recruiting

Australia

Australia
Facility	City	State or region	Status
Nightingale Research Adelaide	Adelaide	South Australia	Recruiting
Flinders Medical Centre - Cardiology Department	Bedford Park	South Australia	Not yet recruiting
Canberra Hospital - Clinical Trials Unit	Canberra	Australian Capital Territory	Not yet recruiting
Heart of Australia	Chelmer	Queensland	Recruiting
The Prince Charles Hospital - Cardiology Clinical Research Centre	Chermside	Queensland	Recruiting
Lyell McEwin Hospital - Clinical Trials Unit	Elizabeth Vale	South Australia	Recruiting
Nightingale Research Victoria	Frankston	Victoria	Recruiting
Adrian Costa Clinical Trials Centre	Geelong	Victoria	Recruiting
Royal Hobart Hospital - Cardiology Department	Hobart	Tasmania	Recruiting
Baker-HeartWest - Hoppers Crossing	Hoppers Crossing	Victoria	Recruiting
Life Clinical Research	Ipswich	Queensland	Recruiting
Advara HeartCare Joondalup	Joondalup	Western Australia	Recruiting
Advara HeartCare Leabrook	Leabrook	South Australia	Recruiting
Sydney Cardiometabolic Centre	Liverpool	New South Wales	Recruiting
Core Research Group	Milton	Queensland	Recruiting
Advara HeartCare Mulgrave	Mulgrave	Victoria	Recruiting

Brazil

Brazil
Facility	City	State or region	Status
Jmf Clínica Do Coração Ltda	Aracaju		Recruiting
CCIH-Consultoria em Controle de Infecção Hospitalar Ltda	Belo Horizonte	Minas Gerais	Recruiting
Grupo AngioKormann	Blumenau	Santa Catarina	Not yet recruiting
Associação Lar São Francisco de Assis na Providência de Deus - Bragança Paulista	Bragança Paulista	São Paulo	Recruiting
Synvia Laboratorios E Toxicologia Ltda	Campinas	São Paulo	Recruiting

788 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

August 18, 2026
Site removed
1 site removed (838 total)
839838

Registry: ClinicalTrials.gov · NCT########

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

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Argentina

Australia

Brazil

Study documents

Changes over time