EMBOLD-HEART
Research type
Research Study
Full title
A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Elecoglipron on Myocardial Energetics and Remodeling in Participants with Overweight or Obesity, and Heart Failure with Ejection Fraction > 40% (EMBOLD-HEART)
IRAS ID
1013908
Contact name
Priya Vasudeva
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
The purpose of the study is to evaluate the effects of elecoglipron on key markers of myocardial health and surrogates of long-term clinical outcomes in patients with heart failure with preserved ejection fraction (HFpEF)/ heart failure with mid-range ejection fraction(HFmrEF) and overweight or obesity, such as myocardial energetics, adverse remodeling parameters, diastolic dysfunction, myocardial perfusion, interstitial
fibrosis, and epicardial adipose tissue volume.The study will provide important insights into the mechanisms for the potential beneficial clinical cardiovascular outcomes of elecoglipron in HFpEF or HFmrEF.
This is a randomized, double-blind, parallel-group, placebo-controlled study sponsored by AstraZeneca and conducted in approximately 12 study sites in the United Kingdom. Approximately 100 participants will be randomized to elecoglipron or placebo. To join this trial participants must be at least 18 years old and have heart failure and overweight or obesity.
The study duration will be up to 58 weeks, comprising of a screening period up to 28 days, a titration treatment period of 20 weeks, maintenance treatment period from Week 21 to 52 and a safety follow-up period 14 days after the last treatment visit. The visit frequency will be approximately every 4 weeks, including visits at the investigational site, visits at the imaging site, and telephone contacts.
During these visits, some tests and procedures will be performed including electrocardiogram (ECG), blood sampling, cardiac imaging, study drug administration, physical examination, monitoring of blood pressure, pulse, respiratory rate, body temperature.
REC name
North East - York Research Ethics Committee
REC reference
26/NE/0061
Date of REC Opinion
17 Jun 2026
REC opinion
Further Information Favourable Opinion