A Phase 3 interventional study of Elecoglipron and Placebo in Heart Failure With Preserved Ejection Fraction (HFpEF) and Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF), sponsored by AstraZeneca. Recruiting at 679 sites in 32 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
Among 61 studies in Heart Failure by AstraZeneca — 6 open to participants now, 8 under way, 3 of them phase 3. Heart Failure · AstraZeneca.
Among the 61 studies in Heart Failure by AstraZeneca, this one is the 2nd largest by planned enrollment of the 39 interventional ones that give a count, is one of 2 that started in 2026, is one of 15 in phase 3, and was the 61st registered.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 6,950 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →6 of the 61 studies in Heart Failure by AstraZeneca are open now, in 12 countries. Each count lists the studies.
Of the 968 Heart Failure studies recruiting now, 691 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 64 take children under 18; 96 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →61 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 9 · Phase 3 16 · Phase 4 2
First in 1999; this study’s year is marked. 2 started in 2026.
Median enrollment 160 across the 39 interventional studies, 823 across the 22 observational. Of the 51 that completed or were terminated, 14 (27%) have results posted.
AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
4 of the studies in Heart Failure by AstraZeneca that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06307652Phase 3AstraZenecaStudy to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function | 2027-04-16 |
| NCT06336330AstraZenecaReal-world Study on Dapagliflozin Usage in Patients With Heart Failure (HF) in Germany | 2026-12-31 |
| NCT07690436AstraZenecaRetinal Fundus Imaging and OCT Imaging for Ocular Detection of ATTR-CM | 2027-06-18 |
| NCT06675552AstraZenecaNon-interventional Study on Guideline Directed Medical Therapy for Patients With Heart Failure (HF) in Germany | 2027-06-30 |
Among the 61 studies in Heart Failure by AstraZeneca, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Elecoglipron tablet once daily
Drug: Elecoglipron
Placebo matching Elecoglipron tablet once daily
Drug: Placebo
Elecoglipron tablet
Placebo tablet
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
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
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
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
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Showing the first 100 of 679 sites across 32 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Sep 2029, 36 months after the start.
Of 63 industry-sponsored phase 3 interventional studies under Heart Failure, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 44. This study's planned 36 months is close to that.
Counting every sponsor, half of 151 studies reached it within 39 months; a quarter within 25 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Elecoglipron