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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.

יצירת קשר עם המחקר

בקצרה

שלב 3דרושים 5,610 משתתפים838 אתרים27 מדינות

קטגוריות

לב וכלי דם71%אנדוקריני ומטבולי29%

רשום במרשם אחד

ClinicalTrials.govNCT07567001פתיחת רשומה זו ב־ClinicalTrials.govסונכרן החודש שעבר

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

תקציר

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.

מצבים רפואיים

Obesity
Heart Failure

זכאות

זכאות
מין	הכול
גילאים	18 Years – ללא מקסימום
מתנדבים בריאים	לא

זכאות כפי שנכתבה במרשם

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.

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

תכנון המחקר
סוג המחקר	התערבותי
שלב	שלב 3
הקצאה	אקראי
מודל ההתערבות	PARALLEL
מטרה ראשית	TREATMENT
הסתרה	QUADRUPLE (4)
גיוס	דרושים 5,610 משתתפים

נותן חסות ושותפים

Novo Nordisk A/S נותן חסות

זרועות והתערבויות

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.

התערבויות

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

מדדי תוצאה

מדד תוצאה ראשוני
Time to first occurrence of a composite Heart Failure (HF) endpoint consisting of cardiovascular (CV) death
Measured in days.
מסגרת זמן From baseline (week 0) to 165 weeks
מדד תוצאה ראשוני
Time to first occurrence of a composite HF endpoint consisting of HF hospitalisation or urgent HF visit
Measured in days.
מסגרת זמן From baseline (week 0) to 165 weeks
מדד תוצאה משני
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.
מסגרת זמן From baseline (week 0) to 165 weeks
מדד תוצאה משני
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.
מסגרת זמן From baseline (week 0) to week 52
מדד תוצאה משני
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.
מסגרת זמן From baseline (week 0) to week 78
מדד תוצאה משני
Time to all-cause death
Measured in days.
מסגרת זמן From baseline (week 0) to 165 weeks

תאריכים

תאריכים
תאריך התחלה	11 במאי 2026 (בפועל)
סיום ראשוני	23 ביולי 2029 (משוער)
סיום	15 באוגוסט 2029 (משוער)
פורסם לראשונה	5 במאי 2026 (בפועל)
עודכן לאחרונה	18 באוגוסט 2026
התוצאות פורסמו	לא צוין ברשומת המרשם
המצב אומת לאחרונה	אוגוסט 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

530 אתרים מגייסים

Argentina

Argentina
מתקן	עיר	מדינה או אזור	מצב
Cardiología Hospital J. M. Ramos Mejia	Buenos Aires		טרם מגייס
Fundación Respirar	Buenos Aires		מגייס
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli	Buenos Aires		מגייס
CEDIC Centro de Investigación Clínica	CABA		טרם מגייס
Glenny Corp. S.A	CABA		מגייס
CEMEDIC	CABA	Buenos Aires	מגייס
Centro de Investigaciones Metabólicas	Capital Federal	Buenos Aires	מגייס
Cardiología Palermo	City of Buenos Aires	Buenos Aires	מגייס
CardiaMet	Ciudad Autonoma de Buenos Aires	Buenos Aires	מגייס
Clínica Privada Velez Sarsfield	Córdoba		מגייס
Centro Médico Luquez	Córdoba		מגייס
Instituto de Investigaciones Clínicas Córdoba	Córdoba		מגייס
Sanatorio Esperanza	Esperanza, Santa Fe		מגייס
Hospital Español de Mendoza	Godoy Cruz, Mendoza	Mendoza Province	מגייס
Centro Medico Capital	La Plata, Buenos Aires		מגייס
Centro Médico CIMEL	Lanús Este	Buenos Aires	מגייס
Hospital Universitario Austral - Instituto de Cardiologia	Pilar	Buenos Aires	מגייס
Instituto Especialidades de la Salud Rosario	Rosario	Santa Fe Province	מגייס
INECO Neurociencias Oroño	Rosario	Santa Fe Province	מגייס
CAICI	Rosario		מגייס
Instituto de Investigaciones Clínicas Rosario	Rosario	Santa Fe Province	מגייס
Centro Cardiovascular Salta	Salta		טרם מגייס
Instituto de Investigaciones de Patologías Respiratorias	San Miguel de Tucumán		מגייס
CMC Cardiología Sociedad Simple	San Miguel de Tucumán		מגייס
Instituto de Investigaciones Clinicas San Nicolás	San Nicolás		מגייס
CEDIR - Centro de diagnóstico y rehabilitación Santa Fe	Santa Fe		מגייס
Centro de Investigaciones Clinica Baigorria	Santa Fe		מגייס
Centro de investigaciones Clinicas del Litoral	Santa Fe		מגייס
MIT Medicina, Investigación y tratamiento	Santa Rosa, La Pampa		מגייס

Australia

Australia
מתקן	עיר	מדינה או אזור	מצב
Nightingale Research Adelaide	Adelaide	South Australia	מגייס
Flinders Medical Centre - Cardiology Department	Bedford Park	South Australia	טרם מגייס
Canberra Hospital - Clinical Trials Unit	Canberra	Australian Capital Territory	טרם מגייס
Heart of Australia	Chelmer	Queensland	מגייס
The Prince Charles Hospital - Cardiology Clinical Research Centre	Chermside	Queensland	מגייס
Lyell McEwin Hospital - Clinical Trials Unit	Elizabeth Vale	South Australia	מגייס
Nightingale Research Victoria	Frankston	Victoria	מגייס
Adrian Costa Clinical Trials Centre	Geelong	Victoria	מגייס
Royal Hobart Hospital - Cardiology Department	Hobart	Tasmania	מגייס
Baker-HeartWest - Hoppers Crossing	Hoppers Crossing	Victoria	מגייס
Life Clinical Research	Ipswich	Queensland	מגייס
Advara HeartCare Joondalup	Joondalup	Western Australia	מגייס
Advara HeartCare Leabrook	Leabrook	South Australia	מגייס
Sydney Cardiometabolic Centre	Liverpool	New South Wales	מגייס
Core Research Group	Milton	Queensland	מגייס
Advara HeartCare Mulgrave	Mulgrave	Victoria	מגייס

Brazil

Brazil
מתקן	עיר	מדינה או אזור	מצב
Jmf Clínica Do Coração Ltda	Aracaju		מגייס
CCIH-Consultoria em Controle de Infecção Hospitalar Ltda	Belo Horizonte	Minas Gerais	מגייס
Grupo AngioKormann	Blumenau	Santa Catarina	טרם מגייס
Associação Lar São Francisco de Assis na Providência de Deus - Bragança Paulista	Bragança Paulista	São Paulo	מגייס
Synvia Laboratorios E Toxicologia Ltda	Campinas	São Paulo	מגייס

788 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

18 באוגוסט 2026
אתר הוסר
1 site removed (838 total)
839838

מרשם: ClinicalTrials.gov · NCT########

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