Phase 3 study

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Novo Nordisk A/S
Registry number NCT07567001
Started 11 May 2026 Today 16 October 2026 Estimated completion 23 July 2029

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Canberra Hospital - Clinical Trials Unit Canberra ACT Not yet recruiting
Sydney Cardiometabolic Centre Liverpool NSW Recruiting
Heart of Australia Chelmer QLD Recruiting
The Prince Charles Hospital - Cardiology Clinical Research Centre Chermside QLD Recruiting
Life Clinical Research Ipswich QLD Recruiting
Core Research Group Milton QLD Recruiting
Nightingale Research Adelaide Adelaide SA Recruiting
Flinders Medical Centre - Cardiology Department Bedford Park SA Not yet recruiting
Lyell McEwin Hospital - Clinical Trials Unit Elizabeth Vale SA Recruiting
Advara HeartCare Leabrook Leabrook SA Recruiting
Royal Hobart Hospital - Cardiology Department Hobart TAS Recruiting
Nightingale Research Victoria Frankston VIC Recruiting
Adrian Costa Clinical Trials Centre Geelong VIC Recruiting
Baker-HeartWest - Hoppers Crossing Hoppers Crossing VIC Recruiting
Advara HeartCare Mulgrave Mulgrave VIC Recruiting
Advara HeartCare Joondalup Joondalup WA Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 5610

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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.

Dates on the record

Started 11 May 2026
Estimated completion 23 July 2029
Registry last updated 18 August 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 18 August 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.