A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Obesity, Heart Failure

In brief

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.

Key facts

Study ID

NCT07567001

Run by

Novo Nordisk A/S

People needed

5610

Starts

2026-05-11

Expected to finish

2029-08-15

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• NorthBay Clinical Research — Santa Rosa, California, United States (enrolling)
• Care Access Research — Thousand Oaks, California, United States (enrolling)
• JPJ Research — Northridge, California, United States (enrolling)
• Fomat Medical Research — Santa Maria, California, United States (enrolling)
• Valiance Clinical Research — Tarzana, California, United States (enrolling)
• Eastern Shore Rsrch Inst, LLC — Fairhope, Alabama, United States (enrolling)
• Advanced Cardiovascular, LLC — Alexander City, Alabama, United States (enrolling)
• Amicis Research Center — Northridge, California, United States (enrolling)
• Desert Oasis Healthcare — Palm Springs, California, United States (enrolling)
• G&J Research — San Diego, California, United States (enrolling)
• Sun City Clinical Research — Glendale, Arizona, United States (enrolling)
• Scripps Hospital — Chula Vista, California, United States (enrolling)
• John Muir Physicians Network — Concord, California, United States (enrolling)
• Valley Clinical Trials — Covina, California, United States (enrolling)
• Mission Cardiovascular Research Institute — Fremont, California, United States (enrolling)
• Amicis Research Center — Granada Hills, California, United States (enrolling)
• California Heart Specialist — Huntington Beach, California, United States (enrolling)
• Valiance Clinical Research — Huntington Park, California, United States (enrolling)
• InvivoCure -2 — Alhambra, California, United States (enrolling)
• Valley Clinical Trials — Northridge, California, United States (enrolling)
• Cardio Research of S. Cal — Beverly Hills, California, United States (enrolling)
• Cardio Innovation & Resch Ctr — Long Beach, California, United States (enrolling)
• Pacific Clinical Studies — Los Alamitos, California, United States (enrolling)
• Westside Medical Associates Los Angeles — Beverly Hills, California, United States (enrolling)
• InvivoCure — Van Nuys, California, United States (enrolling)

Full record on ClinicalTrials.gov

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