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 NCT07564414
Started 21 May 2026 Today 16 October 2026 Estimated completion 23 February 2028

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Sydney Clinical Trials Campbelltown NSW Active not recruiting
Gosford Renal Research Gosford NSW Active not recruiting
Sydney Cardiometabolic Centre Liverpool NSW Active not recruiting
Hunter Diabetes Centre Merewether NSW Active not recruiting
University of Sunshine Coast - Vitality Village Birtinya QLD Active not recruiting
University of Sunshine Coast - South Brisbane South Brisbane QLD Active not recruiting
Emeritus Research Melbourne Camberwell VIC Active not 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 2500

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 :

* Male or female (sex assigned at birth, inclusive of all gender identities).

* Age 18 years or above at the time of signing the informed consent.

* BMI≥ 35.0 kg/m\^2.

* Participants without T2D: No history of T2D and HbA1c \< 6.5% (48 millimoles per mole (mmol/mol)) Participants with T2D: A history of T2D and HbA1c \< 10% (\< 86 mmol/mol). If a participant without a history of diabetes during the screening period receives an HbA1c result of 6.5% (48 mmol/mol) or higher, the investigator or the participant's healthcare provider must confirm the diagnosis of type 2 diabetes before the participant is randomised.

Exclusion Criteria:

* A self-reported change in body weight \> 5% within 90 days before screening, irrespective of medical records.

* Use of any glucagon-like-peptide-1 receptor agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin analogues, including medication with amylin activity, within 6 months before screening.

Dates on the record

Started 21 May 2026
Estimated completion 23 February 2028
Registry last updated 30 September 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: 30 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.