NCT07761117ClinicalTrials.gov

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)

RecruitingTaking participants now, according to the registry record.

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In brief

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…

Phase 36,950 participants sought672 sites32 countries

Registered in 1 registry

ClinicalTrials.govNCT07761117Open this record at ClinicalTrials.govSynced 2 weeks ago

One study can be registered in several registries. We show it once and link every record we hold.

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 2026-08-12; recorded start 2026-08-24
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 1019 other studies in this databaseCounted from the lead sponsor named in the record (AstraZeneca)
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 arm15/15
Active-comparator 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: 366 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: 6,950 participants (target), run at 672 sites, across 32 countries.

How this score is built

Enrolment37/40
6,950 participants (target)
Site count25/25
366 sites
Country count15/15
25 countries
Planned duration8/10
Planned over about 37 months
Sponsor scale10/10
AstraZeneca has led 1,005 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

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF)
Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)

Eligibility

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

Eligibility as written in the registry

Inclusion Criteria: * Left ventricular ejection fraction (LVEF) of \> 40% within 12 months prior to screening. * Structural heart disease evidence. * HF diagnosed with New York Heart Association (NYHA) Class II-IV at the time of screening. Exclusion Criteria: * BMI \<25 kg/m² at screening. * 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: * 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 randomization. * 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: * 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. * 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.

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	6,950 participants sought

Sponsor and collaborators

AstraZeneca Sponsor

Arms and interventions

ElecoglipronEXPERIMENTAL
Elecoglipron tablet once daily
PlaceboACTIVE_COMPARATOR
Placebo matching Elecoglipron tablet once daily

Interventions

Drug Elecoglipron
Elecoglipron tablet
Drug Placebo
Placebo tablet

Outcome measures

Primary outcome
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HHF/urgent HF visit
Time to first event of the composite of: * CV death * HHF * Urgent HF visit
Time frame Up to 42 months
Secondary outcome
To evaluate the effect of elecoglipron compared with placebo in reducing the rate of HF events (HHF or urgent HF visit)
Total occurrences (first and recurrent) of: * HF events * HHF * Urgent HF visit
Time frame Up to 42 months
Secondary outcome
To evaluate the effect of elecoglipron compared to placebo on improving patient-reported outcomes using a questionnaire.
Change from baseline to Week 52
Time frame Baseline and 52 weeks
Secondary outcome
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the 4-point composite of all-cause death, HHF, MI, or stroke
Time to first event of the composite of: * All-cause death * HHF * MI * Stroke
Time frame Up to 42 months

Dates

Dates
Start date	August 24, 2026 (actual)
Primary completion	September 3, 2029 (estimated)
Completion	September 3, 2029 (estimated)
First posted	August 12, 2026 (actual)
Last updated	September 9, 2026
Results posted	Not stated in the registry record
Status last verified	September 2026

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

Locations

11 sites are recruiting

Argentina

Argentina
Facility	City	Status
Research Site	Buenos Aires	Not yet recruiting
Research Site	CABA	Not yet recruiting
Research Site	Ciudad de Buenos Aires	Not yet recruiting
Research Site	Ciudad de Buenos Aires	Not yet recruiting
Research Site	Corrientes	Not yet recruiting
Research Site	Córdoba	Not yet recruiting
Research Site	Córdoba	Not yet recruiting
Research Site	Córdoba	Not yet recruiting
Research Site	Esperanza	Not yet recruiting
Research Site	Granadero Baigorria	Not yet recruiting
Research Site	Lanus	Not yet recruiting
Research Site	Mar del Plata	Not yet recruiting
Research Site	Mendoza	Not yet recruiting
Research Site	Rosario	Not yet recruiting
Research Site	Rosario	Not yet recruiting
Research Site	San Nicolás	Not yet recruiting
Research Site	Santa Fe	Not yet recruiting

Australia

Australia
Facility	City	Status
Research Site	Blacktown	Not yet recruiting
Research Site	Campbelltown	Not yet recruiting
Research Site	Frankston	Not yet recruiting
Research Site	Hoppers Crossing	Not yet recruiting
Research Site	North Tamworth	Not yet recruiting
Research Site	Rockhampton	Not yet recruiting

Austria

Austria
Facility	City	Status
Research Site	Bad Ischl	Not yet recruiting
Research Site	Feldkirch	Not yet recruiting
Research Site	Graz	Not yet recruiting
Research Site	Graz	Not yet recruiting
Research Site	Innsbruck	Not yet recruiting
Research Site	Klagenfurt	Not yet recruiting
Research Site	Linz	Not yet recruiting
Research Site	Saint Stefan/Stainz	Not yet recruiting
Research Site	Sankt Pölten	Not yet recruiting
Research Site	Vienna	Not yet recruiting
Research Site	Vienna	Not yet recruiting
Research Site	Vienna	Not yet recruiting
Research Site	Vienna	Not yet recruiting
Research Site	Wels	Not yet recruiting

Brazil

Brazil
Facility	City	Status
Research Site	Aracaju	Not yet recruiting
Research Site	Belém	Not yet recruiting
Research Site	Bragança Paulista	Not yet recruiting
Research Site	Brasília	Not yet recruiting
Research Site	Campinas	Not yet recruiting
Research Site	Curitiba	Not yet recruiting
Research Site	Joinville	Not yet recruiting
Research Site	Natal	Not yet recruiting
Research Site	Porto Alegre	Not yet recruiting
Research Site	Porto Alegre	Not yet recruiting
Research Site	Ribeirão Preto	Not yet recruiting
Research Site	Rio Branco	Not yet recruiting
Research Site	Rio de Janeiro	Not yet recruiting

622 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

September 9, 2026
Status changed
Status changed from Not yet recruiting to Recruiting
NOT_YET_RECRUITINGRECRUITING
September 9, 2026
Recruitment opened
Recruitment opened
NOT_YET_RECRUITINGRECRUITING
September 9, 2026
Site added
306 sites added (672 total)
366672

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

https://xmedica.io/trials/ctgov/NCT07761117

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

Austria

Brazil

Study documents

Changes over time