CXXB750A12201: XXB750 POC Study in HFREF
Research type
Research Study
Full title
A multi-center, randomized, placebo- and active-controlled, parallel-group, 24-week proof of concept and dose-finding study to evaluate efficacy, safety, and tolerability of XXB750 in patients with heart failure
IRAS ID
1006339
Contact name
Leander Wyss
Contact email
Sponsor organisation
Novartis Pharma AG
Clinicaltrials.gov Identifier
Research summary
The purpose of the trial is to learn which dose of the trial drug ‘XXB750’ is safe and useful in treatment of heart failure. XXB750 is a drug designed to directly activate a protein (receptor) in the body in order to help relax blood vessels and decrease sodium and fluid in the body to reduce the stress on the heart. The trial is designed to find out if XXB750 lowers, amongst others, a certain protein in the blood called NT-proBNP, which is known to show how much stress the heart is dealing with. The trial is also designed to find out which out of 3 doses of XXB750 works best and how it compares to another common HF treatment, and to learn about the safety of XXB750. The trial is a double-blind and placebo-controlled trial, where participants are participating for 24 weeks and will receive injections of study drug XXB750 or placebo every 4 weeks for a total of 4 injections. A certain number of participants in the trial will receive another study drug, sacubitril/valsartan (Entresto®), which is an approved treatment for HF, as tablet to be swallowed twice daily; for these participants, the trial will be open-label.
Trial population will be (1) adults with HF, 18 years or older, (2) Adults who do receive a standard-of-care medication for their HF, i.e. sacubitril/valsartan, angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) in a certain dose, and additional treatments as appropriate (beta-blocker, mineralocorticoid-receptor-antagonist, sodium glucose transporter (SGLT)-2 inhibitor); (3) who have a left ventricular ejection fraction (i.e., proportion of blood pushed out of the heart’s left ventricle) <50%; (4) have a stable blood pressure on their current medication for HF, without low blood pressure episodes; (5) who do not have severely reduced kidney function; (6) other qualification criteria. Subjects will be randomly assigned to one of these treatments, based on the medication for HF that he/she already receives.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
24/NW/0047
Date of REC Opinion
27 Mar 2024
REC opinion
Further Information Favourable Opinion