Efficacy and Safety of NNC0487-0111 Compared to Placebo on Morbidity and Mortality in People With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Novo Nordisk A/S
Summary
This study is being done to look at the safety and effect of NNC0487-0111 in people with Heart Failure with preserved Ejection Fraction (HFpEF) or Heart Failure with mildly reduced Ejection Fraction (HFmrEF) and excess body weight when compared to placebo. The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have HFpEF or HFmrEF and excess body weight. Participants will get NNC0487-0111 or placebo by injection once a week. Which treatment participants get is decided by chance. NNC0487-0111 is a new medicine that doctors cannot prescribe yet, but it has been tested in people before.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Body Mass Index (BMI) greater than or equal to (\>=) 30 kilograms per square metre (kg/m\^2) at screening. * Diagnosis of HF with New York Heart Association (NYHA) class II-IV and in stable condition at screening, at the discretion of the investigator. For participants with Type 2 Diabetes (T2D) at screening: \- Diagnosed with T2D \>= 30 days before screening. Exclusion Criteria: * MI, stroke, unstable angina pectoris or worsening HF leading to either hospitalization or intravenous loop diuretics within 30 days prior to the day of screening and until randomization. *…
Interventions
- DrugNNC0487-0111
NNC0487-011 will be administered subcutaneously.
- DrugPlacebo
Placebo will be administered subcutaneously.
Locations (825)
- Advanced Cardiovascular, LLCAlexander City, Alabama
- Univ of Alabama BirminghamBirmingham, Alabama
- Eastern Shore Rsrch Inst, LLCFairhope, Alabama
- Mobile Heart USA Health Cardiology ClinicMobile, Alabama
- Mercy Gilbert Medical CenterGilbert, Arizona
- Sun City Clinical ResearchGlendale, Arizona