A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity
Recruiting · NCT07567001 · Interventional (participants receive a specific treatment) · Lead sponsor: Novo Nordisk A/S
View the official record on ClinicalTrials.gov →Interventions studied
NNC0487-0111Placebo
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
- HF due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, Chagas cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, or uncorrected primary valve disease of moderate or severe degree.
- Severe pulmonary disease including primary pulmonary hypertension, chronic pulmonary embolism, or severe chronic obstructive pulmonary disease (COPD) defined as:
- requiring home oxygen; or - ongoing oral corticosteroid therapy; or - hospital for COPD Exacerbation within 12 months prior to screening.
- Any other condition judged by the investigator to be the cause of HF symptoms (e.g., anaemia, hypothyroidism).
- Glycaemia-related:
- History of type 1 diabetes.
- Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or who, at the time of screening, are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- Glycated haemoglobin (HbA1c) greater than (\>) 10 percent (%) (86 \[millimoles per mole\] mmol/mol) as measured by local or central laboratory at screening.
Where it is running
60 locations listed across 38 US states.
- Advanced Cardiovascular, LLC - Alexander City, Alabama, United States
- Advanced Cardiovascular, LLC - Alexander City, Alabama, United States
- Univ of Alabama Birmingham - Birmingham, Alabama, United States
- Univ of Alabama Birmingham - Birmingham, Alabama, United States
- Eastern Shore Rsrch Inst, LLC - Fairhope, Alabama, United States
- Eastern Shore Rsrch Inst, LLC - Fairhope, Alabama, United States
- Mobile Heart USA Health Cardiology Clinic - Mobile, Alabama, United States
- Mobile Heart USA Health Cardiology Clinic - Mobile, Alabama, United States
- Mercy Gilbert Medical Center - Gilbert, Arizona, United States
- Mercy Gilbert Medical Center - Gilbert, Arizona, United States
- Sun City Clinical Research - Glendale, Arizona, United States
- Sun City Clinical Research - Glendale, Arizona, United States
- Honor Health - Phoenix, Arizona, United States
- Arizona Research Center - Phoenix, Arizona, United States
- Honor Health - Phoenix, Arizona, United States
- Arizona Research Center - Phoenix, Arizona, United States
- Arkansas Health Group - Little Rock, Arkansas, United States
- Arkansas Health Group - Little Rock, Arkansas, United States
- InvivoCure -2 - Alhambra, California, United States
- InvivoCure -2 - Alhambra, California, United States
- Cardio Research of S. Cal - Beverly Hills, California, United States
- Westside Medical Associates Los Angeles - Beverly Hills, California, United States
- Cardio Research of S. Cal - Beverly Hills, California, United States
- Westside Medical Associates Los Angeles - Beverly Hills, California, United States
- Scripps Hospital - Chula Vista, California, United States
- Scripps Hospital - Chula Vista, California, United States
- John Muir Physicians Network - Concord, California, United States
- John Muir Physicians Network - Concord, California, United States
- Valley Clinical Trials - Covina, California, United States
- Valley Clinical Trials - Covina, California, United States
- Mission Cardiovascular Research Institute - Fremont, California, United States
- Mission Cardiovascular Research Institute - Fremont, California, United States
- Amicis Research Center - Granada Hills, California, United States
- Amicis Research Center - Granada Hills, California, United States
- California Heart Specialist - Huntington Beach, California, United States
- California Heart Specialist - Huntington Beach, California, United States
- Valiance Clinical Research - Huntington Park, California, United States
- Valiance Clinical Research - Huntington Park, California, United States
- Joe C.Wen & Fam CTR for Adv Care - Irvine, California, United States
- Joe C.Wen & Fam CTR for Adv Care - Irvine, California, United States
- Scripps Memorial Hospital La Jolla - La Jolla, California, United States
- UCSD NAFLD Research Center - La Jolla, California, United States
- Scripps Memorial Hospital La Jolla - La Jolla, California, United States
- UCSD NAFLD Research Center - La Jolla, California, United States
- Cardio Innovation & Resch Ctr - Long Beach, California, United States
- Cardio Innovation & Resch Ctr - Long Beach, California, United States
- Pacific Clinical Studies - Los Alamitos, California, United States
- Pacific Clinical Studies - Los Alamitos, California, United States
- VAGrtrLosAngelesHlthcareSystem - Los Angeles, California, United States
- VAGrtrLosAngelesHlthcareSystem - Los Angeles, California, United States
- Amicis Research Center - Northridge, California, United States
- JPJ Research - Northridge, California, United States
- Valley Clinical Trials - Northridge, California, United States
- Amicis Research Center - Northridge, California, United States
- JPJ Research - Northridge, California, United States
- Valley Clinical Trials - Northridge, California, United States
- Desert Oasis Healthcare - Palm Springs, California, United States
- Desert Oasis Healthcare - Palm Springs, California, United States
- Empire Clin. Research - Pomona, California, United States
- Empire Clin. Research - Pomona, California, United States
Showing 60 of 1676 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →