Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around

Description

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.

Official Title

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

Keywords

Obesity, Heart Failure, NNC0487-0111

Eligibility

You can join if…

Open to people ages 18 years and up

  • Body Mass Index (BMI) greater than or equal to (>=) 30 kilograms per square metre (kg/m2) 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 CAN'T join 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.

Locations

  • UCSD NAFLD Research Center
    La Jolla California 92037 United States
  • San Diego Veterans Affairs
    San Diego California 92161 United States
  • Joe C.Wen & Fam CTR for Adv Care
    Irvine California 92612 United States
  • Kaiser Permanente Northern California
    San Francisco California 94118 United States
  • Cardio Research of S. Cal
    Beverly Hills California 90210 United States
  • Scripps Memorial Hospital La Jolla
    La Jolla California 92037 United States
  • San Francisco V.A. Medical Center
    San Francisco California 94121 United States
  • Westside Medical Associates Los Angeles
    Beverly Hills California 90211 United States
  • G&J Research
    San Diego California 92117 United States
  • Valiance Clinical Research
    Tarzana California 91356 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Novo Nordisk A/S
ID
NCT07567001
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 5610 study participants
Last Updated