6950 Participants NeededMy employer runs this trial

Elecoglipron for Heart Failure

(Elevate-HF Trial)

Recruiting at 507 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for adults with heart failure who have either preserved or mildly reduced ejection fraction (HFpEF or HFmrEF). Participants must already be taking dapagliflozin and standard heart failure treatments. People with other major health issues may not qualify.

Inclusion Criteria

I have been diagnosed with structural heart disease.
My heart's pumping ability is above 40% based on a recent test.
I have moderate to severe heart failure right now.

Exclusion Criteria

HbA1c ≥10% at screening
I have had multiple severe low blood sugar episodes or do not notice when they happen.
I am on kidney dialysis or have low kidney function.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either elecoglipron or placebo once daily

Up to 42 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares a new drug, elecoglipron, to a placebo in people with certain types of heart failure. All participants continue their usual medications, including dapagliflozin. The trial is randomized and double-blind, so neither patients nor doctors know who gets which treatment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: ElecoglipronExperimental Treatment1 Intervention
Group II: PlaceboActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology