Testing Elecoglipron for heart failure with preserved ejection fraction (hfpef)
Official title: A Study to Investigate CV Outcomes With Elecoglipron Compared With Placebo in Adult Participants With HFpEF or HFmrEF
A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Cardiovascular Outcomes in Participants With HFpEF and HFmrEF (Elevate-HF)
- Phase 3
- 2 groups
- Sites in Barrie, Etobicoke and 13 more cities
- Recruiting
Interventions
- Medication
Elecoglipron
Elecoglipron tablet
- Medication
Placebo
Placebo tablet
Canadian Sites (21)
5 of 21 recruiting
- Recruiting
Research Site
Kingston, Ontario
- Recruiting
Research Site
Newmarket, Ontario
- Recruiting
Research Site
North York, Ontario
- Recruiting
Research Site
Oakville, Ontario
- Recruiting
Research Site
Stoney Creek, Ontario
- Not yet recruiting
Research Site
Barrie, Ontario
- Not yet recruiting
Research Site
Etobicoke, Ontario
- Not yet recruiting
Research Site
Greater Sudbury, Ontario
- Not yet recruiting
Research Site
Hamilton, Ontario
- Not yet recruiting
Research Site
London, Ontario
- Withdrawn
Research Site
London, Ontario
- Not yet recruiting
Research Site
Markham, Ontario
- Not yet recruiting
Research Site
Markham, Ontario
- Withdrawn
Research Site
North York, Ontario
- Not yet recruiting
Research Site
Ottawa, Ontario
- Withdrawn
Research Site
Thunder Bay, Ontario
- Not yet recruiting
Research Site
Thunder Bay, Ontario
- Not yet recruiting
Research Site
Toronto, Ontario
- Not yet recruiting
Research Site
Toronto, Ontario
- Not yet recruiting
Research Site
Montreal, Quebec
- Not yet recruiting
Research Site
Trois-Rivières, Quebec
Eligibility Criteria
See who this study is looking for19 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Left ventricular ejection fraction (LVEF) of \> 40% within 12 months prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +Structural heart disease evidence.
- +HF diagnosed with New York Heart Association (NYHA) Class II-IV at the time of screening.
Exclusion
- −BMI \<25 kg/m² at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −Diabetes exclusions:
- −History of type 1 diabetes.
- −HbA1c ≥10% at screening.
- −Currently receiving or anticipated to receive therapeutic intervention for diabetic retinopathy and/or macular edema.
- −more than 1 episode of severe hypoglycemic event within 180 days prior to screening, or hypoglycemia unawareness/poor recognition.
- −Renal exclusions:
- −On a prespecified renal replacement therapy, or eGFR below a prespecified threshold at screening
- −Cardiovascular exclusions:
- −Heart failure due to infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, genetic hypertrophic cardiomyopathy (including obstructive), or arrhythmogenic right ventricular cardiomyopathy/dysplasia.
- −GI exclusions:
- −History of acute or chronic pancreatitis.
- −Endocrine exclusions:
- −History/ family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2, or basal calcitonin ≥35 ng/L at screening.
- −Major cardiac surgery, coronary revascularization, valvular repair/replacement, AF/AFL ablation, CRT implantation, or ICD without CRT within 90 days prior to screening, or planned after randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- −Clinically significant upper GI condition affecting gastric emptying, drug absorption, or safety/tolerability interpretation; chronic use of drugs directly affecting GI motility; severe disease or prior surgery.
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 Elecoglipron.
Registry label: A: Elecoglipron
Group B, the comparison group, receives PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
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 — alongside the other treatment that group is given.
One group receives an existing treatment, so the two can be compared.
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 6,950 people.
The study is currently expected to finish around September 2029.
The main measurement is taken over: Up to 42 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
To evaluate the effect of elecoglipron compared with placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → in reducing the risk of CV death or HHF/urgent HF visit — measured over Up to 42 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07761117 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 ElecoglipronDrug
Elecoglipron tablet
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 tablet
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. 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 — alongside the other treatment that group is given.
One group receives an existing treatment so the two can be compared.
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: Up to 42 months.
The study as a whole is currently expected to finish around 2029-09-03.
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 6,950 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 25 locations, including: Barrie, Ontario, Canada; Etobicoke, Ontario, Canada; Greater Sudbury, Ontario, Canada; Hamilton, Ontario, Canada; Kingston, Ontario, Canada; London, Ontario, Canada, and 19 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 is a Phase III, randomized, double-blind, parallel-group, placebo-controlled, multicenter study to investigate CV outcomes with elecoglipron compared with placebo, in adults with heart failure with preserved ejection fraction (HFpEF)/heart failure with mildly reduced ejection fraction (HFmrEF), irrespective of T2DM status, and who are on background dapagliflozin in addition to other background standard of care.
Other Sites (12)
Research Site
Flint, Michigan, United States
Research Site
Southfield, Michigan, United States
Research Site
Southfield, Michigan, United States
Research Site
Troy, Michigan, United States
Research Site
Brooklyn, New York, United States
Research Site
Buffalo, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
Rosedale, New York, United States
Research Site
The Bronx, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Redmond, Washington, United States
If this study interests you
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Keep it with the other studies you are looking at.
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This 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.