Testing NNC0487-0111 against a placebo for obesity
Official title: 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
- Phase 3
- 2 groups
- Sites in Québec, Calgary and 20 more cities
- Recruiting
Interventions
- Medication
NNC0487-0111
NNC0487-011 will be administered subcutaneously.
- Medication
Placebo
Placebo (matched to NNC0487-011) will be administered subcutaneously.
Canadian Sites (27)
13 of 27 recruiting
- Recruiting
University of Calgary
Calgary, Alberta
- Recruiting
G.A. Research Associates Ltd.
Moncton, New Brunswick
- Recruiting
Curnew Medicine Professional Corporation
Hamilton, Ontario
- Recruiting
Cardio Health Clinical Trials
Hamilton, Ontario
- Recruiting
North York Diagn & Cardiac Ctr
North York, Ontario
- Recruiting
Diabetes Heart Research Centre
Toronto, Ontario
- Recruiting
CPS Research
Waterloo, Ontario
- Recruiting
Winchester Dist Memorial Hosp
Winchester, Ontario
- Recruiting
CHU de Quebec-Uni Laval-Hotel
Québec
- Recruiting
IUCPQ - Universite Laval
Québec
- Recruiting
CIUSSS du Saguenay-Lac-St-Jean
Chicoutimi, Quebec
- Recruiting
Diex Recherche Sherbrooke
Sherbrooke, Quebec
- Recruiting
Diex Recherche Trois-Rivieres
Trois-Rivières, Quebec
- Not yet recruiting
St Pauls Hospital
Vancouver, British Columbia
- Not yet recruiting
St. Boniface Hospital
Winnipeg, Manitoba
- Not yet recruiting
Nova Scotia Health
Halifax, Nova Scotia
- Not yet recruiting
Circulate Cardiac and Vascular Centre
Burlington, Ontario
- Not yet recruiting
Med Trust Research, Inc.
Courtice, Ontario
- Not yet recruiting
Cardiac Institute for Research at Queen's - CIRQ
Kingston, Ontario
- Not yet recruiting
Halton Healthcare
Oakville, Ontario
- Not yet recruiting
Kawartha Cardiology Clinical Trials
Peterborough, Ontario
- Not yet recruiting
Corcare Cardiovascular Research
Scarborough Village, Ontario
- Not yet recruiting
Women's College Hospital
Toronto, Ontario
- Not yet recruiting
St. Joseph's Heath Centre
Toronto, Ontario
- Not yet recruiting
CHUM-Hosp de Univ Montreal
Montreal, Quebec
- Not yet recruiting
CISSS BAS ST-LAURENT, HOPITAL regional DE RIMOUSKI
Rimouski, Quebec
- Not yet recruiting
C.I.C. Joliette
Saint-Charles-Borromée, Quebec
Eligibility Criteria
See who this study is looking for13 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Body Mass Index (BMI) greater than or equal to (\>=) 30 kilograms per square metre (kg/m\^2) at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +Diagnosis of HF with New York Heart Association (NYHA) class II-IV and in stable condition at screening, at the discretion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
- +For participants with Type 2 Diabetes (T2D) at screening:
- +\- Diagnosed with T2D \>= 30 days before screening.
Exclusion
- −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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more → 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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- −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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → to be the cause of HF symptoms (e.g., anaemia, hypothyroidism).
- −Glycaemia-related:
- −History of type 1 diabetes.
- −Glycated haemoglobin (HbA1c) greater than (\>) 10 percent (%) (86 \[millimoles per mole\] mmol/mol) as measured by local or central laboratory at screening.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives NNC0487-0111.
Registry label: A: NNC0487-0111
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: B: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 5,610 people.
The study is currently expected to finish around August 2029.
The main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → (week 0) to 165 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Time to first occurrence of a composite Heart Failure (HF) endpointEndpointThe specific thing a study measures to answer its question.Read more → consisting of cardiovascular (CV) death — measured over From baselineBaselineYour starting measurements, taken before treatment begins.Read more → (week 0) to 165 weeks.
Time to first occurrence of a composite HF endpoint consisting of HF hospitalisation or urgent HF visit — measured over From baseline (week 0) to 165 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07567001 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About NNC0487-0111Drug
NNC0487-011 will be administered subcutaneously.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Placebo (matched to NNC0487-011) will be administered subcutaneously.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → (week 0) to 165 weeks.
The study as a whole is currently expected to finish around 2029-08-15.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 5,610 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 36 locations, including: Québec, Canada; Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Moncton, New Brunswick, Canada; Halifax, Nova Scotia, Canada, and 30 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (16)
Cardio and Vascular Assoc-CAVA
Bloomfield Hills, Michigan, United States
Corewell Health
Grand Rapids, Michigan, United States
University Of Michigan
Lansing, Michigan, United States
Henry Ford Health System
Southfield, Michigan, United States
Trinity Health Michigan Heart
Ypsilanti, Michigan, United States
Capital Cardiology Associates_Albany
Albany, New York, United States
Clindove Research
Brooklyn, New York, United States
NYU Langone Med Assoc Chelsea
New York, New York, United States
NYU Langone Orthopedic Center
New York, New York, United States
Mount Sinai Hosp at NYC
New York, New York, United States
Columbia University Medical Center_New York
New York, New York, United States
University of Rochester
Rochester, New York, United States
Laurelton Heart Specialist PC
Rosedale, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Swedish Medical Center_Seattle
Seattle, Washington, United States
CHI Franciscan Research Center
Tacoma, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.