How well NNC0487-0111 works vs placebo in people with obesity and heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial compares weekly injections of NNC0487-0111 to placebo in adults with obesity and heart failure with preserved or mildly reduced ejection fraction. Participants are randomly assigned to receive the drug or placebo and are monitored for safety and effects on heart failure and weight. Eligibility requires BMI ≥30 and stable NYHA class II–IV heart failure, with diabetes allowed if diagnosed at least 30 days before screening. Exclusion criteria include recent major cardiovascular events, certain cardiomyopathies, and significant lung disease. The study is sponsored by Novo Nordisk A/S and conducted at sites in Alabama.

Why it matters

Who can join: the full rules

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's running

• Advanced Cardiovascular, LLC
  Alexander City, Alabama, United States Recruiting
• Eastern Shore Rsrch Inst, LLC
  Fairhope, Alabama, United States Recruiting
• Mercy Gilbert Medical Center
  Gilbert, Arizona, United States Recruiting
• Sun City Clinical Research
  Glendale, Arizona, United States Recruiting
• InvivoCure -2
  Alhambra, California, United States Recruiting
• Cardio Research of S. Cal
  Beverly Hills, California, United States Recruiting

+788 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.