Phase 2, Multicentre, Randomised, Double-blind, Placebo-controlled Safety and Efficacy Study of CDR132L on Reverse Cardiac Remodelling in Participants With Heart Failure With Preserved Ejection Fraction and Left Ventricular Hypertrophy
Novo Nordisk A/S
Summary
This study will look into how CDR132L (a potential new medicine) works on the structure and function of the heart in people living with heart failure. Participants will either get CDR132L or placebo (a medicine which has no effect on the body), which treatment the participants get is decided by chance. The study will last for about 60 weeks.
Eligibility
- Age range
- 40–84 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 40-84 years (both inclusive) at the time of signing the informed consent * Documented symptomatic chronic heart failure (HF) diagnosed greater than or equal to (≥) 90 days prior to screening with at least weekly need for oral diuretic treatment, and New York Heart Association class II-III at screening * Clinically stable and on optimised doses and unchanged drug classes of guideline-directed HF therapy ≥45 days prior to randomisation * Left ventricular ejection fraction ≥50% as assessed by echocardiography at screening, measured by central laboratory * Left ventricul…
Interventions
- DrugCDR132L
CDR132L will be administered intravenously once every 4 weeks.
- DrugPlacebo
Placebo will be administered intravenously once every 4 weeks.
Locations (109)
- Univ of Alabama BirminghamBirmingham, Alabama
- TMC Hlthcr Clin Res OfficeTucson, Arizona
- Pima Heart and VascularTucson, Arizona
- Valley Clinical TrialsCovina, California
- UCSD NAFLD Research CenterLa Jolla, California
- Valley Clinical TrialsNorthridge, California