*Elevate-HF
Research type
Research Study
Full title
A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Effect ofElecoglipron in Reducing Cardiovascular Outcomes in Participantswith HFpEF and HFmrEF (Elevate-HF)
IRAS ID
1013820
Contact name
Ghada Chaabani
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
What this study is about
The study tests if a once daily (OD) pill, elecoglipron, helps people with a type of heart failure live longer & have fewer flare ups versus a look alike inactive pill (placebo). Usual heart failure care continues, including dapagliflozin (10 mg daily). Participants are randomly assigned to take elecoglipron or placebo OD. The study continues until enough heart related events occur to show whether elecoglipron works better than placebo.
Who may be able to join
Adults with heart failure with preserved or mildly reduced pumping function (HFpEF or HFmrEF), with or without type 2 diabetes. People need blood test signs of heart strain & must meet a body size requirement: BMI ≥30 kg/m², or BMI 25 to <30 under certain circumstances. People generally cannot join if recently hospitalized for a major heart problem or procedure; have serious rhythm problems; advanced kidney disease on dialysis; serious liver or lung disease; a history of pancreatitis; risk for medullary thyroid cancer; or certain active hepatitis infections. People with type 2 diabetes may join if HbA1c is below 10%.
What participation involves
Clinic visits for checkups, blood & urine tests, ECGs, and vital signs. Short questionnaires, optional feedback questionnaire & research samples. A subset will have extra blood tests for elecoglipron levels.
What the study is measuring
The main question is whether elecoglipron reduces the chance of dying from cardiovascular causes, being hospitalized for heart failure, or needing an urgent visit for worsening heart failure. The study also tracks total heart failure flare ups, heart attacks, strokes, deaths from any cause, blood pressure, body weight, blood sugar, new type 2 diabetes, cholesterol, inflammation, heart stress blood tests, kidney health & new atrial fibrillation. Safety is closely monitored; common GLP 1–type stomach related side effects usually mild/moderate. An independent committee reviews major events.REC name
London - Westminster Research Ethics Committee
REC reference
26/LO/0282
Date of REC Opinion
5 May 2026
REC opinion
Further Information Favourable Opinion