Which patients are offered and start prescription medicines for obesity
391/2025/OssF/AOUBo
This project will see which people offered prescription medicines for overweight or obesity accept them and how those who start treatment do over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT07414043 on ClinicalTrials.gov |
What this trial studies
This is a multicenter observational project with a cross-sectional phase that records characteristics of all patients who are offered drug therapy for overweight or obesity and a prospective phase that follows patients who choose to start treatment. Data collected will include medical history, social and behavioral factors, clinical and laboratory measurements, and treatment tolerance. Patients aged 12 years and older who have an indication for approved anti-obesity drugs are eligible, while those with type 1 or type 2 diabetes or secondary forms of obesity are excluded. Those who start medication will be followed regularly for up to five years after treatment start or for 12 months after stopping therapy to monitor effectiveness, safety, and adherence in real-world care.
Who should consider this trial
Good fit: Ideal candidates are people aged 12 or older who are offered prescription anti-obesity medications (orlistat, naltrexone/bupropion, liraglutide, semaglutide, or tirzepatide) and do not have diabetes or secondary forms of obesity.
Not a fit: People with type 1 or type 2 diabetes or with secondary/syndromic or endocrinopathic forms of obesity are excluded and will not be represented in the results.
Why it matters
Potential benefit: If successful, the findings could help clinicians target and personalize support and prescribing to improve outcomes and adherence for people using anti-obesity medications.
How similar studies have performed: Real-world observational studies of GLP-1 receptor agonists and other anti-obesity drugs have demonstrated effectiveness and tolerability, but comprehensive long-term phenotyping of who accepts and adheres to therapy is less common.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age ≥ 12 years * Therapeutic indication for taking one of the following drugs for the treatment of obesity: Orlistat, Naltrexone/Bupropion (Mysimba®), Liraglutide (Saxenda®), Semaglutide (Wegovy®), Tirzepatide (Mounjaro®) Exclusion Criteria: - Type 1 and type 2 diabetes mellitus \- Secondary forms of obesity: * Hypothalamic obesity (both monogenic and acquired forms); * Syndromic obesity (e.g., Prader-Willi, Alstrom, Bardet Biedl, etc.); * Endocrinopathies associated with obesity (Cushing's syndrome, uncompensated hypothyroidism)
Where this trial is running
Bologna, Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Uberto Pagotto, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Uberto Pagotto, MD
- Email: uberto.pagotto@unibo.it
- Phone: 0512144190
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.