Testing NNC0487-0111 Against Placebo in Adults With Heart Failure and Excess Weight
Tests the weekly injection NNC0487-0111 against placebo in adults with heart failure and obesity.
Plain-language title generated from the registry record
Registry title: A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity
Key facts
- Where
- Benoni, Bloemfontein, Cape Town, Durban, East London, Johannesburg, Kempton Park, KwaDukuza, Midrand, Mossel Bay, Pietermaritzburg, Polokwane, Pretoria, and Somerset West, South AfricaSee the 24 sites
- Phase
- Phase 3
Where in South Africa
- East Rand Physicians Clinical Research Division (Pty) LtdBenoni, South AfricaNot yet recruiting
- IATROS InternationalBloemfontein, South AfricaTaking people
- Bella Vita Clinical ResearchCape Town, South AfricaTaking people
- Cardiac Clinical Research Unit, University of Cape TownCape Town, South AfricaNot yet recruiting
- Helderberg Research InstituteCape Town, South AfricaNot yet recruiting
- InnoMed Clinical Trial CentreCape Town, South AfricaTaking people
- Tiervlei Trial CentreCape Town, South AfricaTaking people
- Tread Research (Pty)LtdCape Town, South AfricaNot yet recruiting
- Dr Pillay's RoomsDurban, South AfricaNot yet recruiting
- Synapta Clinical ResearchDurban, South AfricaNot yet recruiting
- Synergy Biomed Research InstituteEast London, South AfricaNot yet recruiting
- JohannesburgJohannesburg, South AfricaNot yet recruiting
- Tickerdoc Research (Pty) LTDJohannesburg, South AfricaNot yet recruiting
- Wits Clinical ResearchJohannesburg, South AfricaNot yet recruiting
- Clinresco Centres (Pty) LtdKempton Park, South AfricaNot yet recruiting
- Clinical Research Institute of South AfricaKwaDukuza, South AfricaNot yet recruiting
- Dr A Jacovides and Partners IncMidrand, South AfricaNot yet recruiting
- Dr Hendrik Snyman's PracticeMossel Bay, South AfricaTaking people
- Meditrial Clinical Research CentrePietermaritzburg, South AfricaNot yet recruiting
- Dr MT Makhomisane IncPolokwane, South AfricaNot yet recruiting
- Clinical Trial Systems (CTC)Pretoria, South AfricaTaking people
- Dr IO Ebrahim IncPretoria, South AfricaNot yet recruiting
- Jongaie ResearchPretoria, South AfricaNot yet recruiting
- Clinical Trials Network Helderberg (Pty) LtdSomerset West, South AfricaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novo Nordisk A/S
- Trial code
- NCT07567001EU 2025-523717-29-00
- Record updated
- 18 August 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; requiring home oxygen; or - ongoing oral corticosteroid therapy; or - hospital for COPD Exacerbation within 12 months prior to screening; 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; 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:; 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; Glycated haemoglobin (HbA1c) greater than (>) 10 percent (%) (86 [millimoles per mole] mmol/mol) as measured by local or central laboratory at screening.