Phase 3 study for people with Obesity
Not yet recruiting Phase 3
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Canberra Hospital - Clinical Trials Unit | Canberra | ACT | Status not stated |
| Charles Perkins Centre | Camperdown | NSW | Status not stated |
| Illawarra Heart Health Centre | Wollongong | NSW | Status not stated |
| The Prince Charles Hospital - Cardiology Clinical Research Centre | Chermside | QLD | Status not stated |
| Townsville University Hospital - Cardiology Department | Douglas | QLD | Status not stated |
| Core Research Group | Milton | QLD | Status not stated |
| Rockhampton Hospital | Rockhampton | QLD | Status not stated |
| University of Sunshine Coast - Sippy Downs | Sippy Downs | QLD | Status not stated |
| Royal Adelaide Hospital - Cardiology Department | Adelaide | SA | Status not stated |
| Flinders Medical Centre - Cardiology Department | Bedford Park | SA | Status not stated |
| Northern Health | Epping | VIC | Status not stated |
| St Vincent's Hospital Melbourne - Endocrinology & Diabetes Department | Fitzroy | VIC | Status not stated |
| Adrian Costa Clinical Trials Centre | Geelong | VIC | Status not stated |
| Austin Health - Cardiology Department | Heidelberg | VIC | Status not stated |
| Sunshine Hospital - Western Centre for Health Research and Education | St Albans | VIC | Status not stated |
| Latrobe Regional Hospital - Research Unit | Traralagon | VIC | Status not stated |
| Advara HeartCare Joondalup | Joondalup | WA | Status not stated |
| Nepean Hospital | Kingswood | NSW | Status not stated |
voxsanity.com.au · trial sites from public registries · registry record synced 13 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:
* Established ASCVD is defined as at least one of the below conditions (a-c):
a. Prior myocardial infarction (MI) b. Symptomatic peripheral artery disease (PAD) defined as at least one of the following: i. Intermittent claudication with an ankle-brachial index (ABI) less than (\<) 0.85 at rest ii. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis) c. Cerebrovascular disease defined as the following: i. Prior stroke
* Participants with Type 2 Diabetes (T2D) (at screening) are allowed in the study with the following provisions:
1. Treatment should be stable for greater than or equal to (≥) 90 days before screening as assessed by the investigator.
2. Glucose lowering agents are permitted according to local label except glucagon-like peptide-1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) and amylin analogues; for insulins, only basal insulin is allowed.
Exclusion Criteria:
* MI, stroke, unstable angina pectoris, or worsening heart failure (HF) leading to either hospitalization or intravenous loop diuretics within 30 days prior to the day of screening and until randomization.
* Coronary, carotid, or peripheral artery revascularization or percutaneous valve repair or replacement within 30 days prior to the day of screening or planned during the study period and known at screening.
* Chronic heart failure classified at screening.
* Glycaemia-related:
1. Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
2. Known history of hypoglycaemia unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
3. History of type 1 diabetes (T1D).
4. 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.
5. Glycated haemoglobin (HbA1c) greater than (\>) 10 percentage (%) (86 millimoles per mole \[mmol/mol\]) as measured by central laboratory at screening.
* General health and safety:
1. Treatment with any GLP-1 RA, GIP RA or amylin analogue for any indication before 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: 6 October 2026.
- This page last checked by Voxsanity: 13 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.