DRUG
NNC0487-0111
NNC0487-011 will be administered subcutaneously.
Status
Recruiting
Phase
Phase 3
Enrollment
5,610
Locations
839
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
NNC0487-011 will be administered subcutaneously.
DRUG
Placebo (matched to NNC0487-011) will be administered subcutaneously.
Timeline
First posted
May 5, 2026
Study start
May 11, 2026
Primary completion
Jul 23, 2029
Study completion
Aug 15, 2029
Results posted
Not reported
Registry updated
Jul 15, 2026
Outcomes
Time to first occurrence of a composite Heart Failure (HF) endpoint consisting of cardiovascular (CV) death
Time frame · From baseline (week 0) to 165 weeks
Measured in days.
Time to first occurrence of a composite HF endpoint consisting of HF hospitalisation or urgent HF visit
Time frame · From baseline (week 0) to 165 weeks
Measured in days.
Time to first occurrence of a composite HF and Major Adverse Cardiovascular Events (MACE) end-point consisting of: CV death, HF hospitalisation or urgent HF visit, Nonfatal Myocardial Infraction (MI), Nonfatal stroke
Time frame · From baseline (week 0) to 165 weeks
Measured in days.
Change in Clinical Summary Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-CSS) for participants with baseline KCCQ-CSS score less than (<) 80 points
Time frame · From baseline (week 0) to week 52
Measured as score on scale. KCCQ measures Health-Related Quality of Life (HRQOL). Score ranges from 0 to 100, with 0 as the lowest score and 100 as the highest score. Higher scores indicate better health status, fewer symptoms and greater disease-specific HRQoL.
Change in estimated Glomerular Filtration Rate (eGFR) (creatinine and cystatin C-based Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] 2021) for participants with baseline eGFR< 60 millilitre per minute per 1.73 square metre (mL/min/1.73 m^2)
Time frame · From baseline (week 0) to week 78
Measured as mL/min/1.73 m\^2.
Time to all-cause death
Time frame · From baseline (week 0) to 165 weeks
Measured in days.
Eligibility
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.
Study locations
Argentina · Australia · Brazil · Bulgaria · Canada · China · Czechia · Denmark · France · Germany · Greece · India · Israel · Italy · Japan · Malaysia · Mexico · Netherlands · Poland · Puerto Rico · South Africa · South Korea · Spain · Taiwan · Turkey (Türkiye) · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Advanced Cardiovascular, LLC
Alexander City, Alabama, United States
Univ of Alabama Birmingham
Birmingham, Alabama, United States
Eastern Shore Rsrch Inst, LLC
Fairhope, Alabama, United States
Mobile Heart USA Health Cardiology Clinic
Mobile, Alabama, United States
Mercy Gilbert Medical Center
Gilbert, Arizona, United States
Sun City Clinical Research
Glendale, Arizona, United States
Honor Health
Phoenix, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Arkansas Health Group
Little Rock, Arkansas, 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
Scripps Hospital
Chula Vista, California, United States
John Muir Physicians Network
Concord, California, United States
Valley Clinical Trials
Covina, California, United States
Mission Cardiovascular Research Institute
Fremont, California, United States
Amicis Research Center
Granada Hills, California, United States
California Heart Specialist
Huntington Beach, California, United States
Valiance Clinical Research
Huntington Park, 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
Cardio Innovation & Resch Ctr
Long Beach, California, United States
Pacific Clinical Studies
Los Alamitos, California, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
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