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Taking people in United KingdomPhase 3

Elecoglipron Compared With Placebo in Adults With Certain Types of Heart Failure

Tests elecoglipron against placebo for heart outcomes in adults with HFpEF or HFmrEF.

Key facts

Who runs it
AstraZeneca
Where
Ashton-under-Lyne, Basildon, Belfast, Birmingham, Brighton, Bristol, Cardiff, Clydebank, Dundee, Glasgow, Kings Lynn, Leeds, London, Sandbach, Southampton, and Woodbridge, United KingdomSee the 16 sitesAlso in 31 other countries, 555 sites
Registry title
A Study to Investigate CV Outcomes With Elecoglipron Compared With Placebo in Adult Participants With HFpEF or HFmrEF
Status
Recruiting
Phase
Phase 3
People taking part
6,950 people, planned
Started
24 Aug 2026
Expected to end
3 Sept 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Elecoglipron
  • Placebo
Record updated
28 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with heart failure and a left ventricular ejection fraction above 40%. They take background dapagliflozin. They may or may not have type 2 diabetes. It compares elecoglipron with placebo.

Age
18 years or older
Sex
All sexes can join
Disease stage
Heart failure with preserved or mildly reduced ejection fraction (HFpEF or HFmrEF), NYHA Class II-IV, with left ventricular ejection fraction (LVEF) > 40% within 12 months before screening and evidence of structural heart disease
Earlier treatment
Must be on background dapagliflozin and other standard heart failure care

Main reasons for not taking part

  • BMI below 25 kg/m² at screening
  • Type 1 diabetes, or HbA1c ≥10% (86 mmol/mol) at screening
  • History of acute or chronic pancreatitis
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
  • Major cardiac surgery or procedure within 90 days before screening

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • 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
  • Diabetes exclusions:
  • History of type 1 diabetes
  • Heart failure due to infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, genetic hypertrophic cardiomyopathy (including obstructive), or arrhythmogenic right ventricular cardiomyopathy/dysplasia
  • History of acute or chronic pancreatitis
  • History/ family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2, or basal calcitonin ≥35 ng/L at screening
  • HbA1c ≥10% at screening
  • On a prespecified renal replacement therapy, or eGFR below a prespecified threshold at screening
  • BMI <25 kg/m² at screening
  • Renal exclusions:
  • Cardiovascular exclusions:
  • GI exclusions:
  • Endocrine exclusions:

Where in United Kingdom

Also in 31 other countries, 555 sites

  • Ashton-under-LyneHospital not named in the registryNot yet recruiting
  • BasildonHospital not named in the registryNot yet recruiting
  • BelfastHospital not named in the registryNot yet recruiting
  • BirminghamHospital not named in the registryNot yet recruiting
  • BrightonHospital not named in the registryNot yet recruiting
  • BristolHospital not named in the registryNot yet recruiting
  • CardiffHospital not named in the registryNot yet recruiting
  • ClydebankHospital not named in the registryNot yet recruiting
  • DundeeHospital not named in the registryNot yet recruiting
  • GlasgowHospital not named in the registryNot yet recruiting
  • Kings LynnHospital not named in the registryTaking people
  • LeedsHospital not named in the registryNot yet recruiting
  • LondonHospital not named in the registryTaking people
  • SandbachHospital not named in the registryNot yet recruiting
  • SouthamptonHospital not named in the registryNot yet recruiting
  • WoodbridgeHospital not named in the registryNot yet recruiting

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • ElecoglipronTreatment being tested

    Elecoglipron tablet once daily

  • PlaceboExisting treatment, for comparison

    Placebo matching Elecoglipron tablet once daily

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
Elecoglipron Compared With Placebo in Adults With Certain Types of Heart FailureGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
28 September 2026