OverweightSHAPED-AUNCT07881770
Semaglutide Health Outcomes and Patient Adherence in Australia
An observational study of Overweight and Obesity, run by Novo Nordisk A/S at 1 site in Australia.
Trial summary
This observational study aims to generate real-world evidence on the use of semaglutide in adults with overweight or obesity receiving care through a digital weight loss service (DWLS) programme in Australia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Semaglutide
- How many people
- 10,000 participants
- Where
- 1 siteAustralia
- Study dates
- 13 Oct 2026to 28 Feb 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will recruit individuals who are receiving semaglutide for the management of overweight or obesity and who are enrolled in one of the Eucalyptus Digital Weight Loss Service (DWLS) programmes.
Who may be able to join
- Willing and able to provide informed consent
- Greater than or equal to (>=) 18 years of age at time of informed consent
- Body Mass Index (BMI) >= 27 kg/m2 and have >= 1 excess weight-related comorbidity OR BMI >= 30 kg/m2
- Eligible to be prescribed semaglutide for the management of overweight or obesity
- Have provided at least one weight measurement within 30 days of index date
- Enrolled in existing Eucalyptus DWLS programme.
Who cannot join
- Presence of a documented refusal to participate in research.
- Previous reported use of GLP-1 RA in the 3-month period before index date.
- Are currently taking another obesity medication i.e. medication indicated for weight management treatment.
- Any prior irreversible bariatric surgery for weight management
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Semaglutide Health Outcomes and Patient Adherence on Digital Health Platforms in Australia (SHAPED-AU)
This observational study aims to generate real-world evidence on the use of semaglutide in adults with overweight or obesity receiving care through a digital weight loss service (DWLS) programme in Australia. The study will evaluate treatment patterns, adherence, quality of life, safety, and other health outcomes associated with semaglutide use in routine clinical practice. Information will be collected from data generated during standard clinical care, and no study-specific treatment or procedures will be required.
- Conditions
- Overweight, Obesity
- Being tested
- Semaglutide
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
All decisions regarding treatment will be made at the sole discretion of the treating HCP in accordance with their usual practices. No study medication will be provided as part of the study.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide Cohort | Adults with overweight or obesity who will initiate semaglutide as part of routine clinical care through a digital weight management programme in Australia and will be followed for up to 12 months. Semaglutide will be prescribed by healthcare professionals according to routine clinical practice for the management of overweight or obesity. Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in body weight from baseline
Measured in kilograms (kg).
Measured: 12 months (365 days ±14 days)
Percentage change in body weight from baseline
Measured in percent (%) change from baseline.
Measured: 12 months (365 days ±14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start13 Oct 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eucalyptus Services Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881770
- Sponsor's protocol ID
- NN9536-8871
- Acronym
- SHAPED-AU
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com