Phase 3 study for people with Heart Disease
Recruiting Phase 3
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Research Site | Blacktown | NSW | Not yet recruiting |
| Research Site | Campbelltown | NSW | Not yet recruiting |
| Research Site | Frankston | VIC | Not yet recruiting |
| Research Site | Hoppers Crossing | VIC | Not yet recruiting |
| Research Site | North Tamworth | NSW | Not yet recruiting |
| Research Site | Rockhampton | QLD | Not yet recruiting |
| Research Site | Wollongong | NSW | Not yet recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
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:
* Left ventricular ejection fraction (LVEF) of \> 40% within 12 months prior to screening.
* Structural heart disease evidence.
* HF diagnosed with New York Heart Association (NYHA) Class II-IV at the time of screening.
Exclusion Criteria:
* BMI \<25 kg/m² at screening.
* Diabetes exclusions:
* History of type 1 diabetes.
* HbA1c ≥10% at screening.
* Currently receiving or anticipated to receive therapeutic intervention for diabetic retinopathy and/or macular edema.
* more than 1 episode of severe hypoglycemic event within 180 days prior to screening, or hypoglycemia unawareness/poor recognition.
* Renal exclusions:
* On a prespecified renal replacement therapy, or eGFR below a prespecified threshold at screening
* Cardiovascular exclusions:
* Major cardiac surgery, coronary revascularization, valvular repair/replacement, AF/AFL ablation, CRT implantation, or ICD without CRT within 90 days prior to screening, or planned after randomization.
* Heart failure due to infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, genetic hypertrophic cardiomyopathy (including obstructive), or arrhythmogenic right ventricular cardiomyopathy/dysplasia.
* GI exclusions:
* Clinically significant upper GI condition affecting gastric emptying, drug absorption, or safety/tolerability interpretation; chronic use of drugs directly affecting GI motility; severe disease or prior surgery.
* History of acute or chronic pancreatitis.
* Endocrine exclusions:
* History/ family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2, or basal calcitonin ≥35 ng/L at screening.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 28 September 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.